apotex corp. - Medication Listings

Cladribine tablets contains the nucleoside metabolic inhibitor cladribine, which is a white to off-white crystalline powder with the molecular formula C 10 H 12 ClN 5 O 3 and molecular weight 285.69 g/mol. It differs in structure from the naturally occurring nucleoside, deoxyadenosine, by the substitution of chlorine for hydrogen in the 2-position of the purine ring. The chemical name of cladribine is 2-chloro-2′-deoxy-adenosine. The structural formula is shown below: Cladribine is stable at slightly basic and at neutral pH. The main degradation pathway is hydrolysis and at acidic pH significant decomposition occurs with time. The ionization behavior of the molecule over the pH range 0 to 12 is characterized by a single pKa of approximately 1.21. Cladribine tablets are provided as 10 mg tablet for oral use. Each 10 mg tablet contains cladribine as an active ingredient and magnesium stearate and sorbitol as inactive ingredients. Cladribine tablets also contain hydroxypropyl betadex.

Chemically, clorazepate dipotassium is a benzodiazepine. The molecular formula is C 16 H 11 ClK 2 N 2 O 4 ; the molecular weight is 408.92 g/mol; 1 H -1, 4 Benzodiazepine-3-carboxylic acid, 7-chloro-2, 3-dihydro-2-oxo-5-phenyl-, potassium salt compound with potassium hydroxide (1:1) and the structural formula may be represented as follows:­- The compound occurs as a white or light yellow crystalline powder. It is insoluble in the common organic solvents, but very soluble in water. Aqueous solutions are unstable, clear, light yellow, and alkaline. Each tablet contains 3.75 mg, 7.5 mg and 15 mg of Clorazepate Dipotassium, USP equivalent to 2.9 mg, 5.8 mg and 11.5 mg of Clorazepate. Inactive ingredients for clorazepate dipotassium tablets, USP: Colloidal silicon dioxide, FD&C Blue No. 2 Aluminum Lake (3.75 mg only), FD&C Red No. 40 Aluminum Lake (15 mg only), FD&C Yellow No. 6 Aluminum Lake (7.5 mg only), magnesium oxide, magnesium stearate, microcrystalline cellulose, potassium carbonate, and potassium chloride.

Cyclosporine ophthalmic emulsion, 0.05% contains a topical calcineurin inhibitor immunosuppressant with anti-inflammatory effects. Cyclosporine’s chemical name is Cyclo[[( E )-(2 S ,3 R ,4 R )-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl- N -methylglycyl- N -methyl-L-leucyl-L-valyl- N -methyl-L-leucyl-L-alanyl-D-alanyl- N -methyl-L-leucyl- N -methyl-L-leucyl- N -methyl-L-valyl] and it has the following structure: Structural Formula Formula: C 62 H 111 N 11 O 12 Mol. Wt.: 1202.6 Cyclosporine is a fine white powder. Cyclosporine ophthalmic emulsion appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mOsmol/kg and a pH of 6.5-8.0. Each mL of cyclosporine ophthalmic emulsion contains: Active: cyclosporine 0.05%. Inactives: glycerin; castor oil; polysorbate 80; carbomer copolymer type A; purified water; and sodium hydroxide to adjust pH. Structural Formula

Cyclosporine, USP, the active principle in cyclosporine capsules, USP (NON-MODIFIED) is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Tolypocladium inflatum Gams. Chemically, cyclosporine is designated as [ R -[ R *, R *-( E )]]-cyclic(L-alanyl-D-alanyl- N -methyl-L-leucyl- N -methyl-L-leucyl- N -methyl-L-valyl-3-hydroxy- N ,4-dimethyl-L-2-amino-6-octenoyl-L-α-amino-butyryl- N -methylglycyl- N -methyl-L-leucyl-L-valyl- N -methyl-L-leucyl). Cyclosporine capsules, USP (NON-MODIFIED) are available in 25 mg and 100 mg strengths. Each 25 mg capsule contains: Cyclosporine, USP……………………………………………………………………...25 mg Each 100 mg capsule contains: Cyclosporine, USP……………………………………………………..……………...100 mg Each capsule contains the following inactive ingredients: methanol, sodium lauryl sulfate and talc. The 25 mg and the 100 mg capsule shell contains gelatin, red iron oxide and titanium dioxide. The 25 mg and 100 mg capsule black imprinting ink contains the following inactive ingredients: n-butyl alcohol, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide. The chemical structure of cyclosporine (also known as cyclosporin A) is: structure

Cyclosporine capsule, USP (modified) is an oral formulation of cyclosporine that immediately forms a microemulsion in an aqueous environment. Cyclosporine, USP, the active principle in cyclosporine capsules, USP (modified), is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Beauveria nivea. Chemically, cyclosporine, USP is designated as [ R -[ R *, R *-( E )]]-cyclic-( L -alanyl- D -alanyl- N -methyl- L -leucyl­- N -methyl- L -leucyl- N -methyl- L -valyl-3-hydroxy- N ,4-dimethyl- L -2-amino-6-octenoyl- L -α-aminobutyryl- N -methylglycyl- N -methyl- L -leucyl- L -valyl- N -methyl- L -leucyl). Cyclosporine capsules, USP (modified) (Soft Gelatin Capsules) are available in 25 mg, 50 mg and 100 mg strengths. Each 25 mg capsule contains: cyclosporine, USP…………………………………………………………………...25 mg benzyl alcohol..................................................................... 7.79% v/v (8.13% wt/vol.) Each 50 mg capsule contains: cyclosporine, USP…………………………………………………………………...50 mg benzyl alcohol......................................................................7.79% v/v (8.13% wt/vol.) Each 100 mg capsule contains: cyclosporine, USP…………………………………………………..……………...100 mg benzyl alcohol....................................................................... 7.79% v/v (8.13% wt/vol.) Inactive Ingredients: Polyethylene glycol 400, polyoxyl 35 castor oil, and propylene glycol monolaurate. The capsule shell contains the following inactive ingredients: gelatin, glycerine, iron oxide black (25 mg and 100 mg capsules only) and titanium dioxide. The capsule imprinting ink contains hypromellose, iron oxide black, and propylene glycol. The chemical structure of cyclosporine is: structure

The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N -[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1 H -benzimidazol-5-yl]carbonyl]- N -2-pyridinyl-ethyl ester, methanesulfonate. The molecular formula is C 34 H 41 N 7 O 5 ●CH 4 O 3 S and the molecular weight is 723.86 g/mol. The structural formula is: Dabigatran etexilate mesylate is a yellow to white powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol, very slightly soluble in acetone, practically insoluble in ethyl acetate. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 172.97 mg dabigatran etexilate mesylate, which is equivalent to 150 mg of dabigatran etexilate, 126.86 mg dabigatran etexilate mesylate, which is equivalent to 110 mg dabigatran etexilate, or 86.49 mg dabigatran etexilate mesylate which is equivalent to 75 mg dabigatran etexilate. The capsule fill also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, fumaric acid, magnesium stearate and mannitol. The capsule shell is composed of FD&C blue No.1, hypromellose, iron oxide red, iron oxide yellow, titanium dioxide and edible black ink which consists of non-volatile ingredients ammonium hydroxide, iron oxide black, potassium hydroxide, propylene glycol and shellac. dabigatran etexilate structure

Daptomycin for injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus . The chemical name is N -decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl- threo -3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε 1 -lactone. The chemical structure is: The empirical formula is C 72 H 101 N 17 O 26 ; the molecular weight is 1620.67. Daptomycin for injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized cake containing approximately 500 mg of daptomycin for intravenous (IV) use following reconstitution with 0.9% sodium chloride injection [see Dosage and Administration (2.7) ]. The only inactive ingredient is sodium hydroxide, which is used for pH adjustment. Freshly reconstituted solutions of daptomycin for injection range in color from pale yellow to light brown. Chemical Structure

Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide, monohydrate. The molecular formula is C 22 H 26 ClN 7 O 2 S•H 2 O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01. Dasatinib has the following chemical structure: Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol, methanol, polyethylene glycol 400 and propylene glycol; very slightly soluble in acetone and acetonitrile; and practically insoluble in corn oil. Dasatinib tablets are white to off-white, biconvex, film-coated tablets containing dasatinib, with the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hydroxypropyl cellulose, hypromellose, titanium dioxide and triethyl citrate. Dasatinib tablets are supplied for oral administration. Chemical Structure

Deferoxamine mesylate for injection USP, is an iron-chelating agent, available in vials for injection via intramuscular, subcutaneous, and intravenous administration. Deferoxamine mesylate for injection USP, is supplied as vials containing 500 mg and 2 grams of deferoxamine mesylate USP (corresponding to 426.82 mg and 1.707 grams of deferoxamine as free base) in sterile, lyophilized form. Deferoxamine mesylate is N­-[5-[3-[(5-aminopentyl)hydroxycarbamoyl]propionamido]pentyl]-3-[[5-(N­-hydroxyacetamido) pentyl]carbamoyl]propionohydroxamic acid monomethanesulfonate (salt), and its structural formula is: Deferoxamine mesylate USP is a white crystalline powder. It is freely soluble in water and slightly soluble in methanol. Its molecular weight is 656.79 g/mol.

Desmopressin Acetate Tablets are a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows: Mol. Wt. 1129.27 Empirical Formula: C46H64N14O12S2 • C2H4O2 where 1<x<1.5 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt). Desmopressin acetate tablets, for oral administration, contain either 0.1 or 0.2 mg desmopressin acetate. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, corn starch, and magnesium stearate. desmo-image01

Desmopressin nasal spray, USP is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. The structural formula for the active ingredient is: Mol. wt . 1183.34 g/mol Molecular formula: C 46 H 64 N 14 O 12 S 2 • C 2 H 4 O 2 • 3H 2 O Chemical name: 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin nasal spray, USP is provided as an aqueous solution for intranasal use. Each mL contains: Desmopressin acetate 0.1 mg Inactive: Benzalkonium chloride solution (50% w/v) 0.2 mg Citric acid monohydrate 1.7 mg Sodium chloride 7.5 mg Sodium phosphate dibasic heptahydrate 4.52 mg Purified water to 1 mL The desmopressin nasal spray, USP compression pump delivers 0.1 mL (10 mcg) of desmopressin acetate per spray.

Desogestrel and ethinyl estradiol tablets USP 0.15 mg/0.03 mg provide an oral contraceptive regimen of 21 light orange round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol) and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17,diol). Inactive ingredients include colloidal anhydrous silica, corn starch, ferric oxide red, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, stearic acid, talc, titanium dioxide, and vitamin E. Each green tablet contains the following inactive ingredients: colloidal anhydrous silica, FD&C Blue No.2 Aluminum Lake, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch (maize), talc and titanium dioxide. Desogestrel and Ethinyl Estradiol Tablets USP 0.15 mg/0.03 mg meet USP Dissolution Test 2. deso-ee-structure

Dexamethasone Tablets USP are available for oral administration containing either 0.5 mg, 0.75 mg, 1 mg, 1.5 mg, 2 mg, 4 mg or 6 mg of dexamethasone USP. Each tablet contains the following inactive ingredients: croscarmellose sodium, ferric-ferrous oxide (4 mg only), ferric oxide red (1.5 mg and 6 mg only), ferric oxide yellow (0.5 mg, 1 mg, 4 mg and 6 mg only), magnesium stearate, microcrystalline cellulose, and lactose monohydrate. Dexamethasone, a synthetic adrenocortical steroid, is a white or almost white, crystalline powder. It is practically insoluble in water, sparingly soluble in anhydrous ethanol, slightly soluble in methylene chloride. The molecular formula is C 22 H 29 FO 5 . The molecular weight is 392.46 g/mol. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione and the structural formula is: FDA approved dissolution test method differs from the USP dissolution test methods.

Diclofenac sodium topical solution, USP contains 2% w/w diclofenac sodium, a benzeneacetic acid derivative that is a nonsteroidal anti-inflammatory drug, and is available as a clear, colorless free flowing viscous solution for topical application. The chemical name is 2-[(2,6-Dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.1. Its molecular formula is C 14 H 10 Cl 2 NNaO 2 and it has the following chemical structure: Each 1 gram of solution contains 20 mg of diclofenac sodium. In addition, diclofenac sodium topical solution, USP contains the following inactive ingredients: dimethyl sulfoxide USP (DMSO, 45.5% w/w), ethanol (31.35% v/v), hydroxypropyl cellulose, propylene glycol and purified water.

Diltiazem hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl) monohydrochloride, (+)-cis-. Its molecular formula is C 22 H 26 N 2 O 4 S HCl and its molecular weight is 450.99. Its structural formula is as follows: Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform. DILT-XR [Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage)] complies with USP Drug Release Test #2. DILT-XR [Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage)] contain multiple units of diltiazem HCI extended-release 60 mg, resulting in 120 mg, 180 mg, or 240 mg dosage strengths allowing for the controlled release of diltiazem HCI over a 24-hour period. Inactive Ingredients DILT-XR [Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage)] also contain Black SW-9008/SW9009, colloidal silicon dioxide, D&C Red # No.28, D&C Yellow # No.10, FD&C Blue # No.1, FD&C Red # No.40, gelatin, hypromellose, magnesium stearate, red iron oxide, titanium dioxide and yellow iron oxide. For oral administration.

Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7- dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C 23 H 25 N 5 O 5 • CH 4 O 3 S and the molecular weight is 547.6. It has the following structure: Doxazosin mesylate is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Each doxazosin tablet, USP, for oral administration, contains 1 mg, 2 mg, 4 mg and 8 mg of doxazosin as the free base. In addition, each doxazosin tablet, USP contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose.

Doxycycline capsules 40 mg are hard gelatin capsule shells filled with 33.25 mg immediate release and 6.75 mg delayed release minitablets that together provide a dose of 40 mg of doxycycline. The structural formula of doxycycline, USP is: with a molecular formula of C 22 H 24 N 2 O 8 •H 2 O and a molecular weight of 462.45; 444.43 (anhydrous). The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate (USP). It is very slightly soluble in water. Doxycycline capsules are supplied in 40 mg strength for oral administration containing doxycycline as the active ingredient and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, methacrylic acid and methyl methacrylate copolymer (1:2), microcrystalline cellulose, talc, and triethyl citrate. FDA approved dissolution test method and specifications differ from USP.

Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.03 mg provide an oral contraceptive regimen consisting of 28 film coated tablets that contain the ingredients specified for each tablet below: 21 Yellow, round, biconvex film coated tablets, debossed with ‘EV1’ on one side and plain on other side containing 3 mg drospirenone and 0.03 mg ethinyl estradiol. 7 inert white to off white, round, biconvex, film coated tablets, debossed with ‘EV2’ on one side and plain on other side. The inactive ingredients in the yellow tablets are lactose monohydrate, corn starch, pregelatinized starch (maize), povidone, magnesium stearate, hypromellose, macrogol, titanium dioxide, talc, and ferric oxide pigment, yellow. The white inert film coated tablets contain lactose monohydrate, corn starch, pregelatinized starch (maize), povidone, magnesium stearate, hypromellose, talc, and triacetin. Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11,12,13,14,15, 15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa- [6,7:15,16]cyclopenta[a] phenanthrene-17,2'(5H)-furan]-3,5'(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C 24 H 30 O 3 . Ethinyl estradiol (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3,17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C 20 H 24 O 2 . The structural formulas are as follows: description

Eribulin mesylate injection contains eribulin mesylate, a microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai . The chemical name for eribulin mesylate is 11,15:18,21:24,28-Triepoxy-7,9-ethano-12,15-methano-9 H ,15 H -furo[3,2- i ]furo[2',3':5,6]pyrano[4,3- b ][1,4]dioxacyclopentacosin-5(4 H )-one,2-[(2 S )-3-amino-2-hydroxypropyl]hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)-(2 R ,3 R ,3a S ,7 R ,8a S ,9 S ,10a R ,11 S ,12 R ,13a R ,13b S ,15 S ,18 S ,21 S ,24 S ,26 R ,28 R ,29a S ),methanesulfonate (salt). It has a molecular weight of 826.0 (729.9 for free base). The empirical formula is C 40 H 59 NO 11 •CH 4 O 3 S. Eribulin mesylate has the following structural formula: Eribulin mesylate injection is a clear, colorless, sterile solution for intravenous administration. Each single-dose vial contains 1 mg of eribulin mesylate in 2 mL of solution. Each mL of solution contains 0.5 mg of eribulin mesylate (equivalent to 0.44 mg eribulin) in dehydrated alcohol (5% v/v) and water for injection (95% v/v). Sodium hydroxide or hydrochloric acid may be used for pH adjustment. eribulin-spl-structure

Eribulin mesylate injection contains eribulin mesylate, a microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai . The chemical name for eribulin mesylate is 11,15:18,21:24,28-Triepoxy-7,9-ethano-12,15-methano-9 H ,15 H -furo[3,2- i ]furo[2',3':5,6]pyrano[4,3- b ][1,4]dioxacyclopentacosin-5(4 H )-one,2-[(2 S )-3-amino-2-hydroxypropyl]hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)-(2 R ,3 R ,3a S ,7 R ,8a S ,9 S ,10a R ,11 S ,12 R ,13a R ,13b S ,15 S ,18 S ,21 S ,24 S ,26 R ,28 R ,29a S ),methanesulfonate (salt). It has a molecular weight of 826.0 (729.9 for free base). The empirical formula is C 40 H 59 NO 11 •CH 4 O 3 S. Eribulin mesylate has the following structural formula: Eribulin mesylate injection is a clear, colorless, sterile solution for intravenous administration. Each single-dose vial contains 1 mg of eribulin mesylate in 2 mL of solution. Each mL of solution contains 0.5 mg of eribulin mesylate (equivalent to 0.44 mg eribulin) in dehydrated alcohol (5% v/v) and water for injection (95% v/v). Sodium hydroxide or hydrochloric acid may be used for pH adjustment. eribulin-spl-structure

Ertapenem for injection is a sterile, synthetic, parenteral, 1-β methyl-carbapenem that is structurally related to beta-lactam antibiotics. Chemically, Ertapenem for injection is described as [4R-[3(3S*,5S*),4α,5β,6β(R*)]]-3-[[5-[[(3­carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-(1-hydroxyethyl)-4-methyl-7-oxo-1­ azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monosodium salt. Its molecular weight is 497.50. The empirical formula is C 22 H 24 N 3 O 7 SNa, and its structural formula is: Ertapenem sodium is a white to off-white hygroscopic, weakly crystalline powder. It is soluble in water and 0.9% sodium chloride solution, practically insoluble in ethanol, and insoluble in isopropyl acetate and tetrahydrofuran. Ertapenem for injection is supplied as sterile lyophilized powder for intravenous infusion after reconstitution with appropriate diluent [see Dosage and Administration (2.7) ] and transfer to 50 mL 0.9% Sodium Chloride Injection or for intramuscular injection following reconstitution with 1% lidocaine hydrochloride. Each single-dose vial contains 1 gram ertapenem equivalent to 1.046 grams ertapenem sodium. The sodium content is approximately 137 mg (approximately 6.0 mEq). Each vial of Ertapenem for injection contains the following inactive ingredients: 175 mg sodium bicarbonate and sodium hydroxide to adjust pH to 7.5. Chemcial Structure

The chemical name of eslicarbazepine acetate is (10S)-10-(Acetoxy)-10, 11-dihydro-5Hdibenz [b, f]azepine-5-carboxamide. Eslicarbazepine acetate tablets are a dibenz [b, f] azepine-5-carboxamide derivative. Its molecular formula is C 17 H 16 N 2 O 3 and its molecular weight is 296.33 g/mol. The chemical structure is: Eslicarbazepine acetate is a white to almost white crystalline powder. It is freely soluble in dimethyl sulfoxide and dichloromethane, and soluble in acetonitrile. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg and 800 mg of eslicarbazepine acetate and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.

Etodolac is a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Etodolac is a racemic mixture of [+] S and [-] R-enantiomers. Etodolac is a white or almost white crystalline powder, practically insoluble in water but freely soluble in acetone and in ethanol (96%) The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b] indole-1-acetic acid. The molecular weight of the base is 287.36. It has a pKa of 4.65 and an n-octanol:water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C 17 H 21 NO 3 , and it has the following structural formula: Each etodolac capsule, USP is for oral administration, contains 200 mg or 300 mg of etodolac. In addition, each capsule contains the following inactive ingredients: black iron oxide, black SW-9008/SW-9009, colloidal silicon dioxide, croscarmellose sodium, gelatin, lactose monohydrate, sodium lauryl sulfate, stearic acid, talc and titanium dioxide.

Etodolac is a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Etodolac is a racemic mixture of [+] S and [-] R-enantiomers. Etodolac is a white or almost white crystalline powder, practically insoluble in water but freely soluble in acetone and in ethanol (96%). The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b] indole-1-acetic acid. The molecular weight of the base is 287.36. It has a pKa of 4.65 and an n-octanol:water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C 17 H 21 NO 3 , and it has the following structural formula: Each etodolac tablet, USP is for oral administration, contains 400 mg or 500 mg of etodolac. In addition, each tablet contains the following inactive ingredients: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide. etodolac-01.jpg

The active ingredient in famciclovir tablets is famciclovir, an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir is known as 2-[2-(2-amino-9 H -purin-9-yl)ethyl]-1,3-propanediol diacetate. Its molecular formula is C 14 H 19 N 5 O 4 ; its molecular weight is 321.3. It is a synthetic acyclic guanine derivative and has the following structure Famciclovir is a white to off-white powder. It is freely soluble in acetone and methanol, and sparingly soluble in ethanol and isopropanol. At 25°C famciclovir is freely soluble (greater than 25% w/v) in water initially, but rapidly precipitates as the sparingly soluble (2% to 3% w/v) monohydrate. Famciclovir is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8) P =1.09 and octanol/phosphate buffer (pH 7.4) P =2.08. Famciclovir tablets, USP contain 125 mg, 250 mg or 500 mg of famciclovir, together with the following inactive ingredients: hypromellose, poloxamer, polyethylene glycol, stearic acid, and titanium dioxide. Meets USP Dissolution Test 2.

Fenofibrate capsules, USP is a lipid regulating agent available as capsules for oral administration. Each capsule contains 43 mg or 130 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-­2-methyl-propanoic acid, l-methylethyl ester with the following structural formula: The molecular formula is C 20 H 21 O 4 Cl and the molecular weight is 360.83 g/mol; fenofibrate is insoluble in water. The melting point is 79°C to 82°C. Fenofibrate, USP is a white crystalline powder which is stable under ordinary conditions. Fenofibrate capsules, USP for oral administration contain 43 mg or 130 mg of fenofibrate and the following inactive ingredients: colloidal silicon dioxide, crospovidone and sodium lauryl sulfate. The capsule shell contains D & C Yellow #10, FD & C Blue #2, gelatin and titanium dioxide. The capsule imprinting ink contains ammonium hydroxide, iron oxide black, propylene glycol and shellac. Meets USP Dissolution Test 3

Fentanyl transdermal system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 10.5 cm 2 ). The composition per unit area of all transdermal system sizes is identical. Strength* (mcg/hour) Size (cm 2 ) Fentanyl Content (mg) 12** 5.35 1.38 25 10.7 2.76 37.5 50 16.05 21.4 4.14 5.52 62.5 75 26.75 32.1 6.90 8.28 87.5 100 37.45 42.8 9.66 11.04 * Nominal delivery rate per hour ** Nominal delivery rate is 12.5 mcg/hour The molecular weight of fentanyl base is 336.5 g/mol, and the empirical formula is C 22 H 28 N 2 O. The n-octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is: Fentanyl transdermal system is a rectangular transparent unit comprising a release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are: 1) a backing layer of polyethylene terephalate film; 2) a drug-in-adhesive layer. Before use, a release liner covering the drug-in-adhesive layer is removed and discarded.

Fentanyl transdermal system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 10.5 cm 2 ). The composition per unit area of all transdermal system sizes is identical. Strength* (mcg/hour) Size (cm 2 ) Fentanyl Content (mg) Color of Printing on Back of Patch 12** 5.35 1.38 Orange 25 10.7 2.76 Pink 37.5 50 16.05 21.4 4.14 5.52 Green Green 62.5 75 26.75 32.1 6.90 8.28 Green Blue 87.5 100 37.45 42.8 9.66 11.04 Green Gray * Nominal delivery rate is 12.5 mcg/hour ** Nominal delivery rate per hour The molecular weight of fentanyl base is 336.5 g/mol, and the empirical formula is C 22 H 28 N 2 O. The n-octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is: Fentanyl transdermal system is a rectangular unit comprising a release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are: 1) a backing layer of polyethylene/aluminum/polyester film; 2) a drug-in-adhesive layer. Before use, a release liner covering the drug-in-adhesive layer is removed and discarded. Structure Structure

Fidaxomicin tablets (fidaxomicin) is a macrolide antibacterial drug for oral administration. Its CAS chemical name is Oxacyclooctadeca-3,5,9,13,15-pentaen-2-one, 3-[[[6-deoxy-4- O -(3,5-dichloro-2-ethyl-4,6-dihydroxybenzoyl)-2- O -methyl-β-D-mannopyranosyl]oxy]methyl]-12-[[6-deoxy-5- C -methyl-4- O -(2-methyl-1-oxopropyl)-β-D- lyxo -hexopyranosyl]oxy]-11-ethyl-8-hydroxy-18-[(1 R )-1-hydroxyethyl]-9,13,15-trimethyl-,(3 E ,5 E ,8 S ,9 E ,11 S ,12 R ,13 E ,15 E ,18 S )-.The structural formula of fidaxomicin is shown in Figure 1. Figure 1: Structural Formula of Fidaxomicin Fidaxomicin tablets are film-coated and contain 200 mg of fidaxomicin per tablet and the following inactive ingredients: butylated hydroxytoluene, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, sodium starch glycolate, talc, and titanium dioxide.

Fingolimod, USP is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod, USP is 2-Amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol hydrochloride. Its structure is shown below: Fingolimod hydrochloride, USP is a white to practically white powder that is freely soluble in water and in alcohol and soluble in propylene glycol. It has a molecular weight of 343.93 g/mol. Fingolimod Capsules are provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride, USP equivalent to 0.5 mg of fingolimod, USP. Each Fingolimod Capsules 0.5 mg contains the following inactive ingredients: fumaric acid, stearic acid, pregelatinized starch and empty hard gelatin capsules. The hard gelatin capsule shell contains gelatin, titanium dioxide, and is imprinted with black ink. Black imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. fingo-str-01.jpg

Use s Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion itchy nose runny nose itchy, watery eyes sneezing

Use s Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • itchy nose • runny nose • itchy, watery eyes • sneezing

Fluticasone propionate, the active component of Fluticasone Propionate Nasal Spray USP, is a synthetic corticosteroid having the chemical name S-(fluoromethyl)6α,9-difluoro-11β-17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure: Fluticasone propionate is a white or almost white, crystalline powder with a molecular weight of 500.6, and the molecular formula is C 25 H 31 F 3 O 5 S. It is practically insoluble in water, freely soluble in dimethylformamide, sparingly soluble in acetone and in dichloromethane and slightly soluble in ethanol (95%). Fluticasone Propionate Nasal Spray USP, 50 mcg is an aqueous suspension of microfine fluticasone propionate for topical administration to the nasal mucosa by means of a metering, atomizing spray pump. Fluticasone Propionate Nasal Spray USP also contains 0.02% w/w benzalkonium chloride, dextrose, microcrystalline cellulose and carboxymethylcellulose sodium, 0.25% w/w phenylethyl alcohol, polysorbate 80, purified water, and has a pH between 5 and 7. It is necessary to prime the pump before first use or after a period of non-use (1 week or more). After initial priming (6 actuations), each actuation delivers 50 mcg of fluticasone propionate in 100 mg of formulation through the nasal adapter. Each 16 g bottle of Fluticasone Propionate Nasal Spray USP provides 120 metered sprays. After 120 metered sprays, the amount of fluticasone propionate delivered per actuation may not be consistent and the unit should be discarded.

Fluvoxamine maleate, USP is a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones. It is chemically unrelated to other SSRIs and clomipramine. It is chemically designated as 5-methoxy-4′-(trifluoromethyl) valerophenone (E)-O-(2-aminoethyl) oxime maleate (1:1) and has the molecular formula C 15 H 21 O 2 N 2 F 3 •C 4 H 4 O 4 . Its molecular weight is 434.4. The structural formula is: Fluvoxamine maleate, USP is a white to off-white powder which is sparingly soluble in water, freely soluble in ethanol and chloroform and practically insoluble in diethyl ether. Fluvoxamine maleate tablets, USP are available in 25 mg, 50 mg and 100 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate USP, each tablet contains the following inactive ingredients: hydroxyethyl cellulose (25 mg and 50 mg), hydroxypropyl cellulose (100 mg), hypromellose (100 mg), iron oxide black (100 mg), iron oxide red (100 mg), iron oxide yellow (50 mg and 100 mg), magnesium stearate, mannitol, polyethylene glycol and titanium dioxide. Meets USP Organic Impurities Test 2. fluvoxamine-malea-01

Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is C 21 H 27 N 5 O 4 S; the molecular weight is 445.55; the structural formula is shown below: Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. Glipizide tablets, USP for oral use are available in 5 and 10 mg strengths. Inert ingredients are: anhydrous lactose; colloidal silicon dioxide; magnesium stearate; sodium starch glycolate. Meets USP Dissolution Test 2.

Guanfacine extended-release tablets, USP are a once-daily, extended-release formulation of guanfacine hydrochloride in a matrix tablet formulation for oral administration only. The chemical designation is N -amidino-2-(2,6-dichlorophenyl) acetamide monohydrochloride. The molecular formula is C 9 H 9 Cl 2 N 3 O·HCl corresponding to a molecular weight of 282.55 g/mol. The chemical structure is: Guanfacine hydrochloride, USP is a white to off-white powder, sparingly soluble in water (approximately 1 mg/mL) and alcohol and slightly soluble in acetone. The only organic solvent in which it has relatively high solubility is methanol (>30 mg/mL). Each tablet contains guanfacine hydrochloride, USP equivalent to 1 mg, 2 mg, 3 mg, or 4 mg of guanfacine base. The tablets also contain anhydrous lactose, colloidal silicon dioxide, fumaric acid, hypromellose and magnesium stearate. In addition, the 3-mg and 4-mg tablets also contain FD&C Blue #2 and ferric oxide yellow. Dissolution test pending. spd503-chemical-stucture

Ibandronate sodium is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The chemical name for ibandronate sodium is 1-Hydroxy-3-(methylpentylamino) propylidene]bisphosphonic acid sodium salt. Monohydrate with the molecular formula C 9 H 22 NO 7 P 2 Na•H 2 O and a molecular weight of 359.21. Ibandronate sodium is a white- to off-white powder. It is freely soluble in water and practically insoluble in organic solvents. Ibandronate sodium has the following structural formula: Ibandronate sodium Injection is intended for intravenous administration only. Ibandronate sodium Injection is available as a sterile, clear, colorless, ready-to-use solution in a prefilled syringe that delivers 3.375 mg of ibandronate monosodium salt monohydrate in 3 mL of solution, equivalent to a dose of 3 mg ibandronate free acid. Inactive ingredients include sodium chloride, glacial acetic acid, sodium acetate trihydrate and water for injection. Glacial acetic acid and sodium acetate trihydrate are used to adjust pH. Chemical Structure

Ibandronate sodium is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The drug substance used in ibandronate sodium tablets 150 mg is ibandronate sodium in the form of propylene glycol solvate. The chemical name for ibandronate sodium propylene glycol solvate is monosodium {1-hydroxy-3-[methyl(pentyl) amino]-1-phosphonopropyl} phosphonate propylene glycolate with the molecular formula C 9 H 22 NO 7 P 2 Na•C 3 H 8 O 2 and a molecular weight of 417.30. Ibandronate sodium propylene glycol solvate is a white to off-white powder. It is freely soluble in water and practically insoluble in organic solvents. Ibandronate sodium propylene glycol solvate has the following structural formula: Ibandronate sodium tablets are available as white to off-white oval, biconvex, 150-mg film-coated tablets for once-monthly oral administration. One 150-mg film-coated tablet contains 196 mg of ibandronate sodium propylene glycol solvate, equivalent to 160.25 mg ibandronate sodium or to 150 mg of ibandronic acid. Ibandronate sodium tablets also contain the following inactive ingredients: microcrystalline cellulose, crospovidone, magnesium stearate, and colloidal silicon dioxide. The tablet film coating contains hypromellose, polyethylene glycol 8000, and purified water.

Icosapent ethyl, a lipid-regulating agent, is supplied as a 1 gram oblong, natural colored transparent soft gelatin capsule for oral administration. Each icosapent ethyl capsule contains 1 gram of icosapent ethyl. Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The molecular formula of icosapent ethyl is C 22 H 34 O 2 and the molecular weight is 330.5 g/mol. The chemical name for icosapent ethyl is ethyl (5Z,8Z,11Z,14Z,17Z)-icosa-5,8,11,14,17-pentaenoate with the following chemical structure: Icosapent ethyl capsules (1 gram capsules) also contain the following inactive ingredients: gelatin, glycerine, purified water and tocopherol. The capsule imprinting ink contains ammonium hydroxide, propylene glycol, shellac, simethicone, and titanium dioxide. Chemical Structure

Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.5 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 478 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is: Imatinib mesylate is a white to off-white crystalline powder. Its molecular formula is C 29 H 31 N 7 O • CH 4 SO 3 and its molecular weight is 589.7 g/mol. Imatinib mesylate is freely soluble in water and freely to sparingly soluble in methanol. Inactive Ingredients: colloidal silicon dioxide (NF); crospovidone (NF); and magnesium stearate (NF). Tablet coating: ferric oxide red (NF); ferric oxide yellow (NF); hypromellose (USP); hydroxypropyl cellulose, and polyethylene glycol (NF).

The active ingredient in ipratropium bromide nasal solution is ipratropium bromide monohydrate. It is an anticholinergic agent chemically described as 8-azoniabicyclo (3.2.1) octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate ( endo, syn )-, ( + )-: a synthetic quaternary ammonium compound, chemically related to atropine. The structural formula is: ipratropium bromide C 20 H 30 BrNO 3 •H 2 O monohydrate Mol. Wt. 430.4 Ipratropium bromide is a white to off-white, crystalline substance. It is freely soluble in lower alcohols and water, existing in an ionized state in aqueous solutions, and relatively insoluble in non-polar media. Ipratropium bromide nasal solution, 0.03% is a metered-dose, manual pump spray unit which delivers 21 mcg (70 mcL) ipratropium bromide per spray on an anhydrous basis in an isotonic, aqueous solution. It also contains the following inactive ingredients: benzalkonium chloride, edetate disodium, purified water and sodium chloride. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH to 4.5 to 4.9. Each bottle contains 345 sprays.

The active ingredient in ipratropium bromide nasal solution is ipratropium bromide monohydrate. It is an anticholinergic agent chemically described as 8-azoniabicyclo (3.2.1) octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide monohydrate (endo, syn)-, ( + )-: a synthetic quaternary ammonium compound, chemically related to atropine. Its structural formula is: Ipratropium bromide is a white to off-white crystalline substance. It is freely soluble in lower alcohols and water, existing in an ionized state in aqueous solutions, and relatively insoluble in non-polar media. Ipratropium bromide nasal solution, 0.06% is a metered-dose, manual pump spray unit which delivers 42 mcg ipratropium bromide (on an anhydrous basis) per spray (70 mcL) in an isotonic, aqueous solution. It also contains the following inactive ingredients: benzalkonium chloride, edetate disodium, purified water and sodium chloride. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH to 4.5 to 4.9. Each bottle contains 165 sprays.

Irinotecan hydrochloride injection, USP is an antineoplastic agent of the topoisomerase I inhibitor class. Irinotecan hydrochloride injection, USP is supplied as a sterile, pale yellow, clear, aqueous solution. Each milliliter of solution contains 20 mg of irinotecan hydrochloride (on the basis of the trihydrate salt), 45 mg of sorbitol, NF, and 0.9 mg of lactic acid, USP. The pH of the solution has been adjusted to 3.5 (range, 3.0 to 3.8) with sodium hydroxide or hydrochloric acid. Irinotecan hydrochloride injection, USP is intended for dilution with 5% Dextrose Injection, USP (D5W), or 0.9% Sodium Chloride Injection, USP, prior to intravenous infusion. The preferred diluent is 5% Dextrose Injection, USP. Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as Camptotheca acuminata or is chemically synthesized . The chemical name is ( S ) -4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1 H- pyrano[3’,4’:6,7]-indolizino[1,2-b]quinolin-9-yl-[1,4’bipiperidine]-1’-carboxylate, monohydrochloride, trihydrate. Its empirical formula is C 33 H 38 N 4 O 6 •HCl•3H 2 O and molecular weight is 677.19. It is slightly soluble in water and organic solvents. Its structural formula is as follows: Irinotecan Hydrochloride Irinotecan Hydrochloride Structural formula

Irinotecan hydrochloride injection, USP is an antineoplastic agent of the topoisomerase I inhibitor class. Irinotecan hydrochloride injection, USP is supplied as a sterile, pale yellow, clear, aqueous solution. Each milliliter of solution contains 20 mg of irinotecan hydrochloride (on the basis of the trihydrate salt), 45 mg of sorbitol, NF, and 0.9 mg of lactic acid, USP. The pH of the solution has been adjusted to 3.5 (range, 3.0 to 3.8) with sodium hydroxide or hydrochloric acid. Irinotecan hydrochloride injection, USP is intended for dilution with 5% Dextrose Injection, USP (D5W), or 0.9% Sodium Chloride Injection, USP, prior to intravenous infusion. The preferred diluent is 5% Dextrose Injection, USP. Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as Camptotheca acuminata or is chemically synthesized . The chemical name is ( S ) -4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1 H- pyrano[3’,4’:6,7]-indolizino[1,2-b]quinolin-9-yl-[1,4’bipiperidine]-1’-carboxylate, monohydrochloride, trihydrate. Its empirical formula is C 33 H 38 N 4 O 6 •HCl•3H 2 O and molecular weight is 677.19. It is slightly soluble in water and organic solvents. Its structural formula is as follows: Irinotecan Hydrochloride Irinotecan Hydrochloride Structural formula

IVRA contains melphalan which is an alkylating drug. The chemical name of melphalan hydrochloride is 4-[bis(2-chloroethyl)amino]-L-phenylalanine hydrochloride. The molecular formula is C 13 H 18 Cl 2 N 2 O 2 • HCl and the molecular weight is 341.67. The structural formula is: Melphalan hydrochloride is a white to off-white powder, with a melting range of 199°C to 201°C. It is practically insoluble in water, but freely soluble in 1N HCl and methanol. IVRA is supplied as a sterile, clear colorless to yellow solution in a multiple-dose vial for intravenous use. Each mL contains 90 mg melphalan free base equivalent to 100.75 mg melphalan hydrochloride, 170 mg propylene glycol, 5 mg monothioglycerol, 0.5 mg (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid dihydrate), and 0.025 mL water for injection in polyethylene glycol 400. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH of the drug product solution after dilution with 0.9% sodium chloride ranges from 2.4 - 3.5. Each mL contains 90 mg melphalan free base equivalent to 100.75 mg melphalan hydrochloride.

Ketorolac tromethamine ophthalmic solution 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for topical ophthalmic use. Its chemical name is (±)-5-benzoyl-2,3-dihydro-1 H -pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure Ketorolac tromethamine ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac tromethamine ophthalmic solution contains a racemic mixture of R-(+) and S-(-) - ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of ketorolac tromethamine ophthalmic solution is 290 mOsmol/kg. Each mL of ketorolac tromethamine ophthalmic solution contains: Active: Ketorolac tromethamine 0.5%. Preservative: Benzalkonium chloride 0.01%. Inactives: Edetate disodium dihydrate 0.1%; octoxynol 40; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the pH; and water for injection. Chemical Structure

The chemical name of lacosamide, USP the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide. Lacosamide, USP is a functionalized amino acid. Its molecular formula is C 13 H 18 N 2 O 3 and its molecular weight is 250.30 g/mol. The chemical structure is: Lacosamide, USP is white or almost white or light-yellow powder. It is freely soluble in methanol, soluble in anhydrous ethanol, sparingly soluble in water, slightly soluble in acetonitrile and practically insoluble in heptane. 11.2 Lacosamide Injection, USP Lacosamide injection, USP is a clear, colorless, sterile solution containing 10 mg lacosamide per mL for intravenous infusion. One 20 mL vial contains 200 mg of lacosamide, USP drug substance. The inactive ingredients are sodium chloride (7.6 mg/mL) and water for injection. Hydrochloric acid is used for pH adjustment. Lacosamide injection, USP has a pH of 3.8 to 5.

Lamivudine tablets (HBV) is a synthetic nucleoside analogue with activity against HBV. The drug substance used in lamivudine tablets (HBV) is lamivudine in the form of lamivudine methanol solvate. The chemical name of lamivudine methanol solvate is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)­ )­2(1H)-pyrimidinone methanol solvate. It has a molecular formula of C 8 H 11 N 3 O 3 S• O.2 CH 4 O C 8 H 11 N 3 O 3 S and a molecular weight of 235.66 g/mol. It has the following structural formula: Lamivudine is a white to off-white powder. It is highly soluble in water. Lamivudine tablets (HBV) are for oral administration. Each tablet contains lamivudine methanol solvate equivalent to 100 mg of lamivudine and the inactive ingredients anhydrous lactose, colloidal silicon dioxide, crospovidone, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol and titanium dioxide. Meets with USP dissolution test # 2

Lamivudine is a synthetic nucleoside analogue with activity against HIV-1 and HBV. The drug substance used in lamivudine tablets, USP 150 mg and 300 mg is lamivudine in the form of lamivudine methanol solvate. The chemical name of lamivudine methanol solvate is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-2(1H)-pyrimidinone methanol solvate. It has a molecular formula of C 8 H 11 N 3 O 3 S·0.2CH 4 O and a molecular weight of 235.66 g/mol. It has the following structural formula: Lamivudine methanol solvate is a white to off-white powder. It is highly soluble in water. Lamivudine tablets, USP are for oral administration. Each scored 150-mg film-coated tablet contains lamivudine methanol solvate equivalent to 150 mg of lamivudine and the inactive ingredients colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose anhydrous, magnesium stearate, polyethylene glycol and titanium dioxide. Each 300-mg film-coated tablet contains lamivudine methanol solvate equivalent to 300 mg of lamivudine, and the inactive ingredients colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide black, lactose anhydrous, magnesium stearate, polyethylene glycol and titanium dioxide. Meets USP Dissolution Test 2.

Leflunomide is a pyrimidine synthesis inhibitor. The chemical name for leflunomide is N-(4′-trifluoromethylphenyl)-5-methylisoxazole-4-carboxamide. It has an empirical formula C 12 H 9 F 3 N 2 O 2 , a molecular weight of 270.2 and the following structural formula: Leflunomide tablets, USP are available for oral administration as tablets containing 10 or 20 mg of active drug. Each leflunomide tablet, USP contains anhydrous lactose, colloidal silicon dioxide, crospovidone, and magnesium stearate.