Drugs Similar to ABIRATERONE ACETATE

Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg or 500 mg of abiraterone acetate USP. Abiraterone acetate USP is designated chemically as (3β)­17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg and 500 mg film-coated tablets with the following inactive ingredients: 250 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide. 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP.

Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet contains either 250 mg or 500 mg of abiraterone acetate. Abiraterone acetate is designated chemically as 17-(Pyridin-3-yl)androsta-5,16-dien-3β-yl acetate and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: • 500 mg film-coated tablets: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. • 250 mg uncoated tablets: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate. Meets USP Dissolution Test 3 for the 500 mg tablets. Abiraterone Acetate Structural Formula

Abiraterone acetate, the active ingredient of abiraterone acetate tablets is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet contains 500 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl)-androsta-5,16-dien-3-ol acetate and its structure is: Abiraterone acetate is a white to off-white powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 500 mg film-coated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. FDA approved dissolution test specifications differ from USP. Structure

Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate USP. Abiraterone acetate USP is designated chemically as (3β)­17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg film-coated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide. FDA approved dissolution test specifications differ from USP.

Abiraterone acetate, USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets, USP are available in 250 mg uncoated tablets with the following inactive ingredients: 250 mg uncoated tablets: silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. Meets USP Dissolution Test 3. Chemical Structure

Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet contains 250 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 3.57 and is practically insoluble in water. The pKa at about 25°C is 3.06. Abiraterone acetate Tablets, USP are available in 250 mg uncoated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. structure

Abiraterone acetate, USP the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-‑17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55 g/mol. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate. Structure

Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets and 500 mg film-coated tablets with the following inactive ingredients: 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry ® II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Abiraterone acetate tablets USP, 250 mg meets USP Dissolution Test 3. Abiraterone acetate tablets USP, 500 mg meets USP Dissolution Test 2. 1

Abiraterone acetate, USP the active ingredient of Abiraterone Acetate Tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each Abiraterone acetate tablet contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate, USP is a white or almost white, non-hygroscopic, solid powder and freely soluble in methylene chloride, tetrahydrofuran, and toluene, soluble in methanol, ethanol, ethyl acetate, isobutyl methyl ketone, N,N-dimethylformamide, and acetone, sparingly soluble in acetonitrile and dimethyl sulfoxide, slightly soluble in hexane, very slightly soluble in 0.1 N hydrochloric acid and practically insoluble aqueous media over a wide range of pH values. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.6 g/mol. Abiraterone Acetate Tablets, USP are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: • 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K–30 and sodium lauryl sulfate. The coating, Opadry II 85F500121 Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide. • 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate. FDA approved dissolution test specifications differ from USP. Structure.jpg

Abiraterone acetate, USP the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-acetoxy-17-(3-pyridinyl)androsta-5,16-diene and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55 g/mol. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets and 500 mg film-coated tablets with the following inactive ingredients: 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry ® II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Abiraterone acetate tablets USP, 250 mg meets USP Dissolution Test 3. Abiraterone acetate tablets USP, 500 mg meets USP Dissolution Test 2. Structural Formula

Abiraterone acetate, USP the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-acetoxy-17-(3-pyridinyl)androsta-5,16-diene and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55 g/mol. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets and 500 mg film-coated tablets with the following inactive ingredients: 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry ® II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Abiraterone acetate tablets USP, 250 mg meets USP Dissolution Test 3. Abiraterone acetate tablets USP, 500 mg meets USP Dissolution Test 2. 1

Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg or 500 mg of abiraterone acetate USP. Abiraterone acetate USP is designated chemically as (3β)­17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg and 500 mg film-coated tablets with the following inactive ingredients: 250 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide. 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP.

Abiraterone acetate, USP the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-­17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55 g/mol. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate.

Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Inactive ingredients in the tablets are colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. USP dissolution test pending. 1

Abiraterone acetate, USP the active ingredient of Abiraterone Acetate Tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each Abiraterone acetate tablet contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate, USP is a white or almost white, non-hygroscopic, solid powder and freely soluble in methylene chloride, tetrahydrofuran, and toluene, soluble in methanol, ethanol, ethyl acetate, isobutyl methyl ketone, N,N-dimethylformamide, and acetone, sparingly soluble in acetonitrile and dimethyl sulfoxide, slightly soluble in hexane, very slightly soluble in 0.1 N hydrochloric acid and practically insoluble aqueous media over a wide range of pH values. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.6 g/mol. Abiraterone Acetate Tablets, USP are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: • 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K–30 and sodium lauryl sulfate. The coating, Opadry II 85F500121 Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide. • 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate. FDA approved dissolution test specifications differ from USP. Structure.jpg

Abiraterone acetate, the active ingredient of Abiraterone Acetate tablet is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each Abiraterone Acetate Tablet contains 125 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate is micronized (smaller particle size) white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Inactive ingredients in the tablets are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, sodium stearyl fumarate, butylated hydroxyanisole, butylated hydroxytoluene. image description

Abiraterone acetate, USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets, USP are available in 500 mg film-coated tablets with the following inactive ingredients: 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose PH101, and sodium lauryl sulfate. The coating, Opadry ® 85F100098-CN Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Meets USP Dissolution Test 3. Chemical Structure

Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate or 17-(Pyridin-3-yl)androsta-5,16-dien-3β-yl acetate and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55 g/mol. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets, USP are available in 500 mg and 250 mg film-coated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry ® II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Meets USP Dissolution Test 2. Abiraterone Acetate Structural Formula

Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets, USP are available in 250 mg uncoated tablets with the following inactive ingredients: • 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate (derived from potato). abiraterone-chem-structure

Abiraterone acetate, the active ingredient of abiraterone acetate tablets USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet USP contains 250 mg or 500 mg of abiraterone acetate. Abiraterone is designated chemically as 17-(Pyridin-3-yl)androsta-5,16-dien-3β-yl acetate and its structure is: Abiraterone acetate is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 3.57 (Log P) and Freely soluble in methylene chloride, in tetrahydrofuran, and in toluene, soluble in methanol, in ethanol, in ethyl acetate, in isobutyl methyl ketone, in N,N-dimethyl formamide and in acetone, sparingly soluble in acetonitrile and in dimethyl sulfoxide, slightly soluble in hexane, very slightly soluble in 0.1N hydrochloride and practically insoluble in water. The pKa value of abiraterone Acetate is 3.06. Abiraterone acetate tablets USP are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: • 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The film-coating contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. • 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. 250 mg uncoated tablets : FDA approved dissolution test specifications differ from USP. 500 mg film-coated tablets : Meets USP dissolution test 3. abiraterone-structure

Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets, USP are available in 250 mg uncoated tablets with the following inactive ingredients: • 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate (derived from potato). Chemical Structure

Abiraterone acetate, the active ingredient of abiraterone acetate tablets USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet USP contains 250 mg or 500 mg of abiraterone acetate. Abiraterone is designated chemically as 17-(Pyridin-3-yl)androsta-5,16-dien-3β-yl acetate and its structure is: Abiraterone acetate is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 3.57 (Log P) and Freely soluble in methylene chloride, in tetrahydrofuran, and in toluene, soluble in methanol, in ethanol, in ethyl acetate, in isobutyl methyl ketone, in N,N-dimethyl formamide and in acetone, sparingly soluble in acetonitrile and in dimethyl sulfoxide, slightly soluble in hexane, very slightly soluble in 0.1N hydrochloride and practically insoluble in water. The pKa value of abiraterone Acetate is 3.06. Abiraterone acetate tablets USP are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The film-coating contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulphate. 250 mg uncoated tablets: FDA approved dissolution test specifications differ from USP. 500 mg film-coated tablets: Meets USP dissolution test 3. abiraterone-structure

Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets, USP are available in 250 mg uncoated tablets with the following inactive ingredients: • 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate (derived from potato). abiraterone-structure-02-04-2025.jpg

Abiraterone acetate, the active ingredient of abiraterone acetate tablets USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet USP contains 250 mg or 500 mg of abiraterone acetate. Abiraterone is designated chemically as 17-(Pyridin-3-yl)androsta-5,16-dien-3β-yl acetate and its structure is: Abiraterone acetate is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 3.57 (Log P) and Freely soluble in methylene chloride, in tetrahydrofuran, and in toluene, soluble in methanol, in ethanol, in ethyl acetate, in isobutyl methyl ketone, in N,N-dimethyl formamide and in acetone, sparingly soluble in acetonitrile and in dimethyl sulfoxide, slightly soluble in hexane, very slightly soluble in 0.1N hydrochloride and practically insoluble in water. The pKa value of abiraterone Acetate is 3.06. Abiraterone acetate tablets USP are available in 250 mg and 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: 250 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The film-coating contains iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The film-coating contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. 250 mg uncoated tablets : FDA approved dissolution test specifications differ from USP. 250 mg and 500 mg film-coated tablets : Meets USP dissolution test 3. abiraterone-structure

Abiraterone acetate, USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets, USP are available in 500 mg film-coated tablets with the following inactive ingredients: 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose PH101, and sodium lauryl sulfate. The coating, Opadry ® 85F100098-CN Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Meets USP Dissolution Test 3. Chemical Structure

Abiraterone acetate, USP the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-‑17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55 g/mol. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate. Structure

Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate or 17-(Pyridin-3-yl)androsta-5,16-dien-3β-yl acetate and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55 g/mol. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets, USP are available in 500 mg and 250 mg film-coated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry ® II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Meets USP Dissolution Test 2. Abiraterone Acetate Structural Formula

Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg or 500 mg of abiraterone acetate USP. Abiraterone acetate USP is designated chemically as (3β)­17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg and 500 mg film-coated tablets with the following inactive ingredients: 250 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide. 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP.

Abiraterone acetate, USP the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-­17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55 g/mol. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate.

Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg or 500 mg of abiraterone acetate USP. Abiraterone acetate USP is designated chemically as (3β)­17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg and 500 mg film-coated tablets with the following inactive ingredients: 250 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide. 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP.

Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet contains either 250 mg or 500 mg of abiraterone acetate. Abiraterone acetate is designated chemically as 17-(Pyridin-3-yl)androsta-5,16-dien-3β-yl acetate and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: • 500 mg film-coated tablets: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. • 250 mg uncoated tablets: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate. Meets USP Dissolution Test 3 for the 500 mg tablets. Abiraterone Acetate Structural Formula

Abiraterone acetate, the active ingredient of Abiraterone Acetate tablet is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each Abiraterone Acetate Tablet contains 125 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate is micronized (smaller particle size) white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Inactive ingredients in the tablets are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, sodium stearyl fumarate, butylated hydroxyanisole, butylated hydroxytoluene. image description

Abiraterone acetate, the active ingredient of abiraterone acetate tablets is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet contains 500 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl)-androsta-5,16-dien-3-ol acetate and its structure is: Abiraterone acetate is a white to off-white powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 500 mg film-coated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. FDA approved dissolution test specifications differ from USP. Structure

Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet contains 250 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 3.57 and is practically insoluble in water. The pKa at about 25°C is 3.06. Abiraterone acetate Tablets, USP are available in 250 mg uncoated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. structure

Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate USP. Abiraterone acetate USP is designated chemically as (3β)­17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg film-coated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide. FDA approved dissolution test specifications differ from USP.

Abiraterone acetate, USP the active ingredient of Abiraterone Acetate Tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each Abiraterone acetate tablet contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate, USP is a white or almost white, non-hygroscopic, solid powder and freely soluble in methylene chloride, tetrahydrofuran, and toluene, soluble in methanol, ethanol, ethyl acetate, isobutyl methyl ketone, N,N-dimethylformamide, and acetone, sparingly soluble in acetonitrile and dimethyl sulfoxide, slightly soluble in hexane, very slightly soluble in 0.1 N hydrochloric acid and practically insoluble aqueous media over a wide range of pH values. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.6 g/mol. Abiraterone Acetate Tablets, USP are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: • 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K–30 and sodium lauryl sulfate. The coating, Opadry II 85F500121 Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide. • 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate. FDA approved dissolution test specifications differ from USP. Structure.jpg

Abiraterone acetate, USP the active ingredient of Abiraterone Acetate Tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each Abiraterone acetate tablet contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate, USP is a white or almost white, non-hygroscopic, solid powder and freely soluble in methylene chloride, tetrahydrofuran, and toluene, soluble in methanol, ethanol, ethyl acetate, isobutyl methyl ketone, N,N-dimethylformamide, and acetone, sparingly soluble in acetonitrile and dimethyl sulfoxide, slightly soluble in hexane, very slightly soluble in 0.1 N hydrochloric acid and practically insoluble aqueous media over a wide range of pH values. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.6 g/mol. Abiraterone Acetate Tablets, USP are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: • 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K–30 and sodium lauryl sulfate. The coating, Opadry II 85F500121 Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide. • 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate. FDA approved dissolution test specifications differ from USP. Structure.jpg

Abiraterone acetate, USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets, USP are available in 250 mg uncoated tablets with the following inactive ingredients: 250 mg uncoated tablets: silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. Meets USP Dissolution Test 3. Chemical Structure

Abiraterone acetate, the active ingredient of abiraterone acetate tablets USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet USP contains 250 mg or 500 mg of abiraterone acetate. Abiraterone is designated chemically as 17-(Pyridin-3-yl)androsta-5,16-dien-3β-yl acetate and its structure is: Abiraterone acetate is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 3.57 (Log P) and Freely soluble in methylene chloride, in tetrahydrofuran, and in toluene, soluble in methanol, in ethanol, in ethyl acetate, in isobutyl methyl ketone, in N,N-dimethyl formamide and in acetone, sparingly soluble in acetonitrile and in dimethyl sulfoxide, slightly soluble in hexane, very slightly soluble in 0.1N hydrochloride and practically insoluble in water. The pKa value of abiraterone Acetate is 3.06. Abiraterone acetate tablets USP are available in 250 mg and 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: 250 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The film-coating contains iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The film-coating contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. 250 mg uncoated tablets : FDA approved dissolution test specifications differ from USP. 250 mg and 500 mg film-coated tablets : Meets USP dissolution test 3. abiraterone-structure

Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets, USP are available in 250 mg uncoated tablets with the following inactive ingredients: • 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate (derived from potato). abiraterone-structure-02-04-2025.jpg

Abiraterone acetate, the active ingredient of abiraterone acetate tablets USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet USP contains 250 mg or 500 mg of abiraterone acetate. Abiraterone is designated chemically as 17-(Pyridin-3-yl)androsta-5,16-dien-3β-yl acetate and its structure is: Abiraterone acetate is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 3.57 (Log P) and Freely soluble in methylene chloride, in tetrahydrofuran, and in toluene, soluble in methanol, in ethanol, in ethyl acetate, in isobutyl methyl ketone, in N,N-dimethyl formamide and in acetone, sparingly soluble in acetonitrile and in dimethyl sulfoxide, slightly soluble in hexane, very slightly soluble in 0.1N hydrochloride and practically insoluble in water. The pKa value of abiraterone Acetate is 3.06. Abiraterone acetate tablets USP are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: • 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The film-coating contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. • 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. 250 mg uncoated tablets : FDA approved dissolution test specifications differ from USP. 500 mg film-coated tablets : Meets USP dissolution test 3. abiraterone-structure

Abiraterone acetate, the active ingredient of abiraterone acetate tablets USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet USP contains 250 mg or 500 mg of abiraterone acetate. Abiraterone is designated chemically as 17-(Pyridin-3-yl)androsta-5,16-dien-3β-yl acetate and its structure is: Abiraterone acetate is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 3.57 (Log P) and Freely soluble in methylene chloride, in tetrahydrofuran, and in toluene, soluble in methanol, in ethanol, in ethyl acetate, in isobutyl methyl ketone, in N,N-dimethyl formamide and in acetone, sparingly soluble in acetonitrile and in dimethyl sulfoxide, slightly soluble in hexane, very slightly soluble in 0.1N hydrochloride and practically insoluble in water. The pKa value of abiraterone Acetate is 3.06. Abiraterone acetate tablets USP are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The film-coating contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulphate. 250 mg uncoated tablets: FDA approved dissolution test specifications differ from USP. 500 mg film-coated tablets: Meets USP dissolution test 3. abiraterone-structure

Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets, USP are available in 250 mg uncoated tablets with the following inactive ingredients: • 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate (derived from potato). abiraterone-chem-structure

Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets, USP are available in 250 mg uncoated tablets with the following inactive ingredients: • 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate (derived from potato). Chemical Structure

Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg or 500 mg of abiraterone acetate USP. Abiraterone acetate USP is designated chemically as (3β)­17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg and 500 mg film-coated tablets with the following inactive ingredients: 250 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide. 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP.

Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets and 500 mg film-coated tablets with the following inactive ingredients: 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry ® II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Abiraterone acetate tablets USP, 250 mg meets USP Dissolution Test 3. Abiraterone acetate tablets USP, 500 mg meets USP Dissolution Test 2. 1

Abiraterone acetate, USP the active ingredient of Abiraterone Acetate Tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each Abiraterone acetate tablet contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate, USP is a white or almost white, non-hygroscopic, solid powder and freely soluble in methylene chloride, tetrahydrofuran, and toluene, soluble in methanol, ethanol, ethyl acetate, isobutyl methyl ketone, N,N-dimethylformamide, and acetone, sparingly soluble in acetonitrile and dimethyl sulfoxide, slightly soluble in hexane, very slightly soluble in 0.1 N hydrochloric acid and practically insoluble aqueous media over a wide range of pH values. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.6 g/mol. Abiraterone Acetate Tablets, USP are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: • 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K–30 and sodium lauryl sulfate. The coating, Opadry II 85F500121 Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide. • 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate. FDA approved dissolution test specifications differ from USP. Structure.jpg

Abiraterone acetate, the active ingredient of abiraterone acetate tablets is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet contains 500 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl)-androsta-5,16-dien-3-ol acetate and its structure is: Abiraterone acetate is a white to off-white powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 500 mg film-coated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. FDA approved dissolution test specifications differ from USP. Structure

Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate USP. Abiraterone acetate USP is designated chemically as (3β)­17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg film-coated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide. FDA approved dissolution test specifications differ from USP.

Abiraterone acetate, the active ingredient of Abiraterone Acetate tablet is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each Abiraterone Acetate Tablet contains 125 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate is micronized (smaller particle size) white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Inactive ingredients in the tablets are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, sodium stearyl fumarate, butylated hydroxyanisole, butylated hydroxytoluene. image description

Abiraterone acetate, USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets, USP are available in 250 mg uncoated tablets with the following inactive ingredients: 250 mg uncoated tablets: silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. Meets USP Dissolution Test 3. Chemical Structure

Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Inactive ingredients in the tablets are colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. USP dissolution test pending. 1

Abiraterone acetate, USP the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-‑17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55 g/mol. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate. Structure

Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains 250 mg or 500 mg of abiraterone acetate USP. Abiraterone acetate USP is designated chemically as (3β)­17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg and 500 mg film-coated tablets with the following inactive ingredients: 250 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide. 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicified microcrystalline cellulose, sodium lauryl sulfate, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP.

Abiraterone acetate, USP the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate, USP is designated chemically as (3β)-acetoxy-17-(3-pyridinyl)androsta-5,16-diene and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55 g/mol. Abiraterone acetate, USP is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 250 mg uncoated tablets and 500 mg film-coated tablets with the following inactive ingredients: 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, silicified microcrystalline cellulose, and sodium lauryl sulfate. The coating, Opadry ® II Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Abiraterone acetate tablets USP, 250 mg meets USP Dissolution Test 3. Abiraterone acetate tablets USP, 500 mg meets USP Dissolution Test 2. 1

Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet contains either 250 mg or 500 mg of abiraterone acetate. Abiraterone acetate is designated chemically as 17-(Pyridin-3-yl)androsta-5,16-dien-3β-yl acetate and its structure is: Abiraterone acetate, USP is a white to off-white, non-hygroscopic, powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 5.12 (Log P) and is practically insoluble in water. The pKa of the aromatic nitrogen is 5.19. Abiraterone acetate tablets are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: • 500 mg film-coated tablets: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin. • 250 mg uncoated tablets: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate. Meets USP Dissolution Test 3 for the 500 mg tablets. Abiraterone Acetate Structural Formula

Abiraterone acetate, USP the active ingredient of Abiraterone Acetate Tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each Abiraterone acetate tablet contains either 250 mg or 500 mg of abiraterone acetate, USP. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate, USP is a white or almost white, non-hygroscopic, solid powder and freely soluble in methylene chloride, tetrahydrofuran, and toluene, soluble in methanol, ethanol, ethyl acetate, isobutyl methyl ketone, N,N-dimethylformamide, and acetone, sparingly soluble in acetonitrile and dimethyl sulfoxide, slightly soluble in hexane, very slightly soluble in 0.1 N hydrochloric acid and practically insoluble aqueous media over a wide range of pH values. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.6 g/mol. Abiraterone Acetate Tablets, USP are available in 500 mg film-coated tablets and 250 mg uncoated tablets with the following inactive ingredients: • 500 mg film-coated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K–30 and sodium lauryl sulfate. The coating, Opadry II 85F500121 Purple, contains iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide. • 250 mg uncoated tablets: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate. FDA approved dissolution test specifications differ from USP. Structure.jpg

Abiraterone acetate, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet contains 250 mg of abiraterone acetate. Abiraterone acetate is designated chemically as (3β)-17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate and its structure is: Abiraterone acetate USP is a white to off-white, non-hygroscopic, crystalline powder. Its molecular formula is C 26 H 33 NO 2 and it has a molecular weight of 391.55. Abiraterone acetate is a lipophilic compound with an octanol-water partition coefficient of 3.57 and is practically insoluble in water. The pKa at about 25°C is 3.06. Abiraterone acetate Tablets, USP are available in 250 mg uncoated tablets with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. structure