cipla usa inc. - Medication Listings

Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine: The chemical name of FTC is 5-fluoro-1-(2 R ,5 S )-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C 8 H 10 FN 3 O 3 S and a molecular weight of 247.24. It has the following structural formula: FTC is a white to off-white crystalline powder with a solubility of approximately 112 mg/mL in water at 25°C. The partition coefficient (log p) for emtricitabine is -0.43 and the pKa is 2.65. Tenofovir Disoproxil Fumarate: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[( R )-2 [[bis[[(isopropoxycarbonyl)oxy]- methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C 19 H 30 N 5 O 10 P • C 4 H 4 O 4 and a molecular weight of 635.52. It has the following structural formula: Tenofovir disoproxil fumarate is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in water at 25 °C. The partition coefficient (log p) for tenofovir disoproxil is 1.25 and the pKa is 3.75. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration. Each film-coated tablet contains 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate, (which is equivalent to 245 mg of tenofovir disoproxil), as active ingredients. The tablets also include the following inactive ingredients: Lactose Monohydrate, Croscarmellose Sodium, Microcrystalline Cellulose, Pregelatinized Starch, Magnesium Stearate, Opadry Blue II 32K505061 which contains Lactose monohydrate, hypromellose, titanium dioxide, triacetin, FD&C Blue #2 Aluminium lake. Image Image

Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine: The chemical name of FTC is 5-fluoro-1-(2 R ,5 S )-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C 8 H 10 FN 3 O 3 S and a molecular weight of 247.24. It has the following structural formula: FTC is a white to off-white crystalline powder with a solubility of approximately 112 mg/mL in water at 25°C. The partition coefficient (log p) for emtricitabine is -0.43 and the pKa is 2.65. Tenofovir Disoproxil Fumarate: TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[( R )-2 [[bis[[(isopropoxycarbonyl)oxy]- methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C 19 H 30 N 5 O 10 P • C 4 H 4 O 4 and a molecular weight of 635.52. It has the following structural formula: Tenofovir disoproxil fumarate is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in water at 25 °C. The partition coefficient (log p) for tenofovir disoproxil is 1.25 and the pKa is 3.75. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration. Each film-coated tablet contains 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate, (which is equivalent to 245 mg of tenofovir disoproxil), as active ingredients. The tablets also include the following inactive ingredients: Lactose Monohydrate, Croscarmellose Sodium, Microcrystalline Cellulose, Pregelatinized Starch, Magnesium Stearate, Opadry II 32K580000 White which contains Lactose monohydrate, hypromellose, titanium dioxide, triacetin. emtricitabine-structure tdf-structure

Entecavir, a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1, 9-dihydro-9-[( 1S, 3R, 4S )-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6 H -purin-6-one, monohydrate. Its molecular formula is C 12 H 15 N 5 O 3 •H 2 O, which corresponds to a molecular weight of 295.3. Entecavir has the following structural formula: Entecavir, USP is a white to off-white powder. It is slightly soluble in water (2.4 mg/mL), and the pH of the saturated solution in water is 7.9 at 25° C ± 0.5° C. Entecavir film-coated tablets USP are available for oral administration in strengths of 0.5 mg and 1 mg of entecavir. Entecavir 0.5 mg and 1 mg film-coated tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone, and magnesium stearate. The tablet coating contains titanium dioxide, hypromellose, polyethylene glycol and iron oxide red (1 mg tablet only). image

Exemestane tablets, USP for oral administration contain 25 mg of exemestane, an irreversible, steroidal aromatase inactivator. Exemestane is chemically described as 6-methylenandrosta-1,4-diene-3,17-dione. Its molecular formula is C 20 H 24 O 2 and its structural formula is as follows: The active ingredient is a white to slightly yellow crystalline powder with a molecular weight of 296.40. Exemestane is freely soluble in N, N-dimethylformamide, soluble in methanol, and practically insoluble in water. Each exemestane tablet, USP contains the following inactive ingredients: mannitol, crospovidone, hypromellose, polysorbate 80, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate. The film-coating contains: hypromellose, titanium dioxide and polyethylene glycol 6000. Structure of Exemestane

Fenofibrate capsules, USP (micronized) are a lipid regulating agent available as capsules for oral administration. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2- methylpropanoic acid, 1-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; fenofibrate is insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Each 67 mg fenofibrate capsule contains the following inactive ingredients: lactose monohydrate, crospovidone, povidone, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, FD&C Blue No.1, FD&C Red No.3, D&C Yellow No.10, titanium dioxide and gelatin. Each 134 mg fenofibrate capsule contains the following inactive ingredients: lactose monohydrate, crospovidone, povidone, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, FD&C Blue No.1, D&C Red No.28, titanium dioxide and gelatin. Each 200 mg fenofibrate capsule contains the following inactive ingredients: lactose monohydrate, crospovidone, povidone, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, FD&C Blue No.1, FD&C Red No.40, FD&C Yellow No.6, titanium dioxide and gelatin. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. USP dissolution test is pending. Fenofibrate Structural Formula

Fenofibrate, is a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula: The empirical formula is C 20 H 21 O 4 Cl and the molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Inactive Ingredients Each tablet contains hypromellose 2910 (3 cps), docusate sodium, sucrose, sodium lauryl sulfate, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, and magnesium stearate. In addition, individual tablets contain: 48 mg tablets polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum, D&C Yellow #10 aluminum lake, FD&C Yellow #6 /sunset yellow FCF aluminum lake, FD&C Blue #2 /indigo carmine aluminum lake. 145 mg tablets polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum. image

Fosfomycin tromethamine granules for oral solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: mandarin flavor, orange powder flavor, saccharin, and sucrose. The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (1 R ,2 S )-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white or almost white, hygroscopic powder with a molecular weight of 259.19. Its empirical formula is C 3 H 7 O 4 P.C 4 H 11 NO 3 , and its chemical structure is as follows: Image

Fosinopril sodium tablet, USP is the sodium salt of fosinopril USP, the ester prodrug of an angiotensin converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin converting enzyme. Fosinopril sodium, USP is designated chemically as: L-proline,4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy) propoxy](4-phenylbutyl)phosphinyl]acetyl]-, sodium salt, trans-. Fosinopril sodium, USP is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is: Its empirical formula is C 30 H 45 NNaO 7 P, and its molecular weight is 585.65. Fosinopril Sodium, USP is available for oral administrations as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: crospovidone, lactose, microcrystalline cellulose, magnesium stearate, and povidone. image

Fosinopril sodium, USP is a white to off-white crystalline powder, soluble (> 100 mg/mL) in water, in ethanol, and in methanol, and slightly soluble in hexane. Fosinopril sodium, USP's chemical name is L-proline, 4-cyclohexyl-1-[[[2- methyl-1-(1-oxopropoxy)-propoxy]-(4 phenylbutyl)-phosphinyl] acetyl]-, sodium salt, trans-; its structural formula is: Fosinoprilat, the active metabolite of fosinopril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Fosinopril is converted to fosinoprilat by hepatic cleavage of the ester group. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide's chemical name is 6-chloro-3,4-dihydro-2 H -1 ,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide; its structural formula is: Hydrochlorothiazide is a thiazide diuretic. Fosinopril sodium and hydrochlorothiazide tablets are a combination of fosinopril sodium and hydrochlorothiazide, USP. It is available for oral use in two tablet strengths: fosinopril sodium and hydrochlorothiazide tablets, 10 mg/12.5 mg, containing 10 mg of fosinopril sodium and 12.5 mg of hydrochlorothiazide, USP; and fosinopril sodium and hydrochlorothiazide tablets, 20 mg/12.5 mg, containing 20 mg of fosinopril sodium and 12.5 mg of hydrochlorothiazide, USP. The inactive ingredients of the tablets include lactose anhydrous, crospovidone, povidone USP, microcrystalline cellulose, sodium stearate and Talc USP. fosinopril-structure hydrochlorothiazide-structure

Gemfibrozil, USP is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, NF; croscarmellose sodium, NF; calcium stearate, NF; microcrystalline cellulose, NF; methylcellulose, USP and opadry white. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula: The empirical formula is C 15 H 22 O 3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58° to 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions. image

Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is synthesized by solid phase peptide synthesis. The chemical structure of the glucagon is identical to human glucagon. Glucagon is a single-chain polypeptide that contains 29 amino acid residues and has a molecular weight of 3483 Daltons. The empirical formula is C 153 H 225 N 43 O 49 S. The primary sequence of glucagon is shown below. Crystalline glucagon is a white to off-white powder. It is relatively insoluble in water but is soluble at a pH of less than 3 or more than 9.5. Glucagon for injection, USP is a sterile lyophilized white to off white powder in a vial and a syringe of sterile diluent for intravenous, intramuscular, or subcutaneous use. The vial contains 1 mg of glucagon, 49 mg of lactose monohydrate. Hydrochloric acid may have been added during manufacture to adjust the pH of the glucagon to 2.5 to 3.0. One International Unit of glucagon is equivalent to 1 mg of glucagon. The 1-mL diluent syringe contains 12 mg of glycerin, 1 mg hydrochloric acid, and Water for Injection, at pH 1.8 to 2.2. emperical-formula

Griseofulvin oral suspension USP (microsize) contains griseofulvin, USP (microsize) for oral administration. The active ingredient, griseofulvin, USP, is a fungistatic antibiotic, derived from a species of Penicillium . The chemical name of griseofulvin, USP is 7-Chloro-2',4,6-trimethoxy-6'b-methylspiro[benzofuran-2(3H),1'-[2]cyclohexene]- 3,4'-dione. Its structural formula is: Griseofulvin, USP occurs as a white to creamy white, odorless powder which is very slightly soluble in water, soluble in acetone, dimethylformamide, and chloroform and sparingly soluble in alcohol. Griseofulvin is a pink to orange colored, tutti-frutti flavored, uniform suspension. Each 5 mL of griseofulvin suspension contains 125 mg of griseofulvin, USP (microsize) and also contains the following inactive ingredients: artificial flavors, carboxymethyl cellulose sodium, dl-alpha-tocopherol, FD&C red #40, FD&C yellow #6, glycerin, hydrochloric acid, methylparaben, microcrystalline cellulose, propylene glycol, propylparaben, simethicone emulsion, sodium alginate, sodium hydroxide, sodium lauryl sulfate and sucrose. Image

Hydrocortisone sodium succinate for injection, USP is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate, USP as the active ingredient. Hydrocortisone sodium succinate for injection, USP is available in below mentioned package for intravenous or intramuscular administration. 100 mg Plain —Vials containing hydrocortisone sodium succinate, USP equivalent to 100 mg hydrocortisone, 0.8 mg monobasic sodium phosphate anhydrous, 8.73 mg dibasic sodium phosphate dried. Hydrocortisone sodium succinate for injection, USP 100 mg plain does not contain diluent (see DOSAGE AND ADMINISTRATION , Preparation of Solutions ). When necessary, the pH was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8. The chemical name for hydrocortisone sodium succinate is pregn-4-ene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11β)- and its molecular weight is 484.52. The structural formula is represented below: Hydrocortisone sodium succinate is a white or nearly white, odorless, hygroscopic amorphous solid. It is very soluble in water and in alcohol, very slightly soluble in acetone, and insoluble in chloroform. Image

Icatibant is a synthetic decapeptide with five non-proteinogenic amino acids. The chemical structure of icatibant acetate is presented in Figure 1. Figure 1 Chemical Structure Chemical name: D-Arginyl-L-arginyl-L-prolyl-L[(4R)-4-hydroxyprolyl]-glycyl-L[3-(2-thienyl)alanyl]-L-seryl-D-(1,2,3,4-tetrahydroisoquinolin-3-ylcarbonyl)-L[(3aS,7aS)-octahydroindol-2-ylcarbonyl]-L-arginine, acetate salt Icatibant injection 30 mg/3ml (10 mg/mL) is provided as a sterile, isotonic, and buffered solution of icatibant acetate in a single-dose, prefilled syringe for subcutaneous administration. Each mL of the solution contains 10 mg of icatibant (free base) which is equilvalent to 11.38 mg of icatibant acetate. Each prefilled syringe delivers 3 mL of solution equivalent to a 30 mg icatibant dose. The solution is clear and colorless. The solution also contains sodium chloride (isotonicity reagent), glacial acetic acid (pH adjuster), sodium hydroxide (pH adjuster) and water for injection with a pH of approximately 5.5. The solution does not contain preservatives. Pharmacological class: Icatibant is a bradykinin B2 receptor antagonist. Image

The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP are albuterol sulfate and ipratropium bromide. Albuterol sulfate, is a salt of racemic albuterol and a relatively selective β 2 -adrenergic bronchodilator chemically described as α1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-α, α'-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C 13 H 21 NO 3 ) 2 •H 2 SO 4 . It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. Figure 3 1-1. Chemical structure of albuterol sulfate. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8 -azoniabicyclo [3.2.1]-octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C 20 H 30 BrNO 3 •H 2 O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Figure 3. 1-2. Chemical structure of ipratropium bromide. Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP contains 3.0 mg (0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg (0.017%) of ipratropium bromide in an isotonic, sterile, aqueous solution containing sodium chloride, hydrochloric acid to adjust to pH 4, and edetate disodium, USP (a chelating agent). Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution,USP like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus™ nebulizer (with face mask or mouthpiece) connected to a PRONEB™ compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION ). 1 2

The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution are albuterol sulfate and ipratropium bromide. Albuterol sulfate, is a salt of racemic albuterol and a relatively selective β 2 -adrenergic bronchodilator chemically described as α 1 -[( tert -butylamino)methyl]-4-hydroxy- m -xylene-α, α'-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C 13 H 21 NO 3 ) 2 •H 2 SO 4 . It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. Figure 3.1-1. Chemical structure of albuterol sulfate. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]-octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8methyl-8-(1-methylethyl)-, bromide, monohydrate ( endo, syn )-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C 20 H 30 BrNO 3 •H 2 O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Figure 3.1-2. Chemical structure of ipratropium bromide. Each 3 mL Sterile Unit-dose Vial contains 0.5 mg of ipratropium bromide (0.017%) and 3 mg Equivalent to 2.5 mg albuterol base albuterol sulfate (0.083%) in an isotonic, sterile, aqueous solution containing sodium chloride and 1 N hydrochloric acid to adjust to pH 4 *Equivalent to 2.5 mg albuterol base Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus® nebulizer (with face mask or mouthpiece) connected to a PRONEB® compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION) albuterol sulfate iprabr

Isoproterenol hydrochloride is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a beta-adrenergic agonist and a synthetic sympathomimetic amine that is structurally related to epinephrine. The molecular formula is C 11 H 17 NO 3 ·HCl. It has a molecular weight of 247.72 and the following structural formula: Isoproterenol hydrochloride is a racemic compound. Each milliliter of the sterile solution contains: Isoproterenol hydrochloride, USP 0.2 mg Edetate disodium USP (EDTA) 0.2 mg Sodium citrate, dihydrate USP 2.07 mg Citric acid, anhydrous USP 2.5 mg Sodium chloride USP 7.0 mg Hydrochloric acid NF q.s to adjust pH Sodium hydroxide NF q.s to adjust pH Water for Injection USP q.s to 1.0 mL The pH is adjusted between 2.5 and 4.5 with hydrochloric acid NF and/or sodium hydroxide NF. The sterile solution is nonpyrogenic and can be administered by the intravenous route. Image

Lanreotide Injection 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL is a prolonged-release formulation for deep subcutaneous injection. It contains the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occurring somatostatin, water for injection and acetic acid (for pH adjustment). Lanreotide Injection is available as sterile, ready-to-use, single-dose prefilled syringes containing lanreotide acetate supersaturated bulk solution of 24.6% w/w lanreotide base. Each syringe contains: Lanreotide Injection 60 mg/0.2 mL Lanreotide Injection 90 mg/0.3 mL Lanreotide Injection 120 mg/0.5 mL Lanreotide acetate 89.9 mg 123.2 mg 156.6 mg Acetic Acid q.s. q.s. q.s. Water for injection 236.4 mg 324.1 mg 411.6 mg Total Weight 328.9 mg 450.9 mg 572.8 mg Lanreotide acetate is a synthetic cyclical octapeptide analog of the natural hormone, somatostatin. Lanreotide acetate is chemically known as [cyclo S-S]-3-(2-naphthyl)-D­ alanyl-L-cysteinyl-L-tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamide, acetate salt. Its molecular weight is 1096.34 (base) and its amino acid sequence is: The Lanreotide Injection in the prefilled syringe is a white to pale yellow, semi-solid formulation. Chemical Structure

Lanreotide Injection 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL is a prolonged-release formulation for deep subcutaneous injection. It contains the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occurring somatostatin, water for injection and acetic acid (for pH adjustment). Lanreotide Injection is available as sterile, ready-to-use, single-dose prefilled syringes containing lanreotide acetate supersaturated bulk solution of 24.6% w/w lanreotide base. Each syringe contains: LANREOTIDE ACETATE LANREOTIDE ACETATE LANREOTIDE ACETATE 60 mg/0.2 mL 90 mg/0.3 mL 120 mg/0.5 mL Lanreotide acetate 74.9 mg 108.2 mg 141.5 mg Acetic Acid q.s. q.s. q.s. Water for injection 196.8 mg 284.5 mg 372.1 mg Total Weight 273.9 mg 395.9 mg 517.8 mg Lanreotide acetate is a synthetic cyclical octapeptide analog of the natural hormone, somatostatin. Lanreotide acetate is chemically known as [cyclo S-S]-3-(2-naphthyl)-D-alanyl-L-cysteinyl-L- tyrosyl-D-tryptophyl-L-lysyl-L-valyl-L-cysteinyl-L-threoninamide, acetate salt. Its molecular weight is 1096.34 (base) and its amino acid sequence is: The Lanreotide Injection in the prefilled syringe is a white to pale yellow, semi-solid formulation. structure

Lanthanum carbonate chewable tablets contains lanthanum carbonate with molecular formula La 2 (CO3) 3 and molecular weight 457.8 (anhydrous mass). Lanthanum carbonate is described as white to almost-white powder. Lanthanum carbonate is practically insoluble in water and is insoluble in organic solvents; it dissolves in dilute mineral acids with effervescence. Each lanthanum carbonate chewable tablet, off-white to yellowish, chewable tablet contains lanthanum carbonate equivalent to 500, 750, or 1,000 mg of elemental lanthanum and the following inactive ingredients: microcrystalline cellulose, guar gum, sucralose, hydroxypropyl cellulose, dextrates, colloidal silicon dioxide, stearic acid, magnesium stearate.

Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2 H -isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure: 3-(4-amino-1-oxo 1,3-dihydro-2 H -isoindol-2-yl) piperidine-2,6-dione The empirical formula for lenalidomide is C 13 H 13 N 3 O 3 , and with relative molecular mass 259.26 a.m.u. Lenalidomide is an off-white to pale-yellow solid powder. It is freely soluble in dimethyl formamide and practically insoluble in water, diethyl ether, ethanol and buffered aqueous solvents. Solubility was significantly lower in buffers, ranging from 1.2 to 6.8 as 0.01g in 100 mL. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. Lenalidomide is available in 2.5 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The 2.5 mg capsule shell contains FD&C Blue # 2, gelatin, titanium dioxide, and yellow iron oxide. The imprinting ink of 2.5 mg contains black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Image

Lenalidomide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2 H -isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure: 3-(4-amino-1-oxo 1,3-dihydro-2 H -isoindol-2-yl) piperidine-2,6-dione The empirical formula for lenalidomide is C 13 H 13 N 3 O 3 , and with relative molecular mass 259.27. Lenalidomide is an off-white to pale-yellow solid powder. It is freely soluble in dimethyl formamide and practically insoluble in water, diethyl ether, ethanol, and buffered aqueous solvents. Solubility was significantly lower in buffers, ranging from ranging from 1.2 to 6.8 as 0.01g in 100 mL. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. Lenalidomide capsules are available in 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 10 mg capsule shell contains gelatin, yellow iron oxide, indigotine FD&C Blue # 2, titanium dioxide, and black ink. The 15 mg capsule shell contains gelatin, indigotine FD&C Blue # 2, titanium dioxide, and black ink. The 20 mg capsule shell contains gelatin, yellow iron oxide, FD&C Blue # 2, titanium dioxide, and black ink. The imprinting ink for 5 mg, 10 mg, 15 mg and 25 mg contains black iron oxide, potassium hydroxide, propylene glycol, purified water, and shellac. The imprinting ink for 20 mg contains black iron oxide, D & C yellow # 10, FD & C blue # 1, FD & C blue # 2, FD & C red # 40, and propylene glycol and shellac glaze. Image

Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula: Where: n=1 or 2 Leuprolide acetate has a molecular weight of 1209.41 as free base”. Leuprolide is freely soluble in water. LEUPROLIDE ACETATE FOR DEPOT SUSPENSION 22.5 mg for 3-month administration is available in a vial containing white to off white sterile lyophilized microspheres together with the corresponding sterile reconstitution diluent in a pre-filled syringe. When LEUPROLIDE ACETATE FOR DEPOT SUSPENSION and the diluent are mixed together they become a suspension intended as an intramuscular injection to be given ONCE EVERY 12 WEEKS as a single dose. Each vial of LEUPROLIDE ACETATE FOR DEPOT SUSPENSION 22.5 mg for 3-month administration delivers leuprolide acetate (22.5 mg), polylactic acid (188.4 mg), triethylcitrate (10.4 mg), polysorbate 80 (3.8 mg), mannitol (88.4 mg) and carmellose sodium (25 mg). The prefilled syringe containing the clear reconstitution diluent (2 mL) contains mannitol (16 mg), water for injections, and sodium hydroxide and hydrochloric acid to control pH. Leuprolide acetate for depot suspension is an extended release sterile, single dose injection in suspension form for intramuscular administration. fig 11

Liraglutide injection contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. Liraglutide is manufactured by synthetic process. The peptide precursor of liraglutide has been manufactured to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor. The molecular formula of liraglutide is C 172 H 265 N 43 O 51 and the molecular weight is 3751.2 Daltons. The structural formula (Figure 1) is: Figure 1. Structural Formula of Liraglutide Liraglutide injection is a sterile, aqueous, clear, colorless or almost colorless solution for subcutaneous use. Each 1 mL of liraglutide injection solution contains 6 mg of liraglutide and the following inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection. Liraglutide injection has a pH of approximately 8.15, hydrochloric acid or sodium hydroxide may be added to adjust pH. Each prefilled pen contains a 3 mL solution of liraglutide injection equivalent to 18 mg liraglutide (free-base, anhydrous). Figure 1

Lisinopril and hydrochlorothiazide tablets, USP combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C 21 H 31 N 3 O 5 . 2H 2 O and its structural formula is: Lisinopril, USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7 H 8 ClN 3 O 4 S 2 and its structural formula is: Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.72, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and hydrochlorothiazide tablets, USP are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg, containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide, lisinopril and hydrochlorothiazide tablets 20 mg/12.5 mg, containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide and lisinopril and hydrochlorothiazide tablets 20 mg/25 mg, containing 20 mg lisinopril and 25 mg hydrochlorothiazide. Inactive ingredients are dibasic calcium phosphate anhydrous, mannitol, corn starch, pre-gelatinized starch and magnesium stearate. Lisinopril and hydrochlorothiazide tablets USP, 10 mg/12.5 mg and 20 mg/25 mg also contain both yellow iron oxide and red iron oxide. Structural formula 1 Structural formula 2

Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride. Its molecular formula is C 28 H 36 N 4 O 2 S·HCl and its molecular weight is 529.14. The chemical structure is: Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, corn starch, hydroxy Propyl methyl cellulose, colloidal silicon dioxide, magnesium stearate, titanium dioxide, hypermellose, polyethelene glycol, polysorbate and additionally 80 mg tablets contains yellow iron oxide and FDC Blue #2/Indigotine Aluminum lake (12 to 14% dye). structure.

Meprobamate is a white powder with a characteristic odor and a bitter taste. It is slightly soluble in water, freely soluble in acetone and alcohol, and sparingly soluble in ether. The structural formula of meprobamate is: C 9 H 18 N 2 O 4 M.W.218.25 Meprobamate Tablets USP 200 mg and 400 mg for oral administration contain the following inactive ingredients: microcrystalline cellulose,sodium starch glycolate, pre-gelatinized starch, colloidal silicondioxide, stearic acid and magnesium stearate. structure

Metaxalone tablets, USP are available as 400 mg round shaped, light pink tablets. Chemically, metaxalone, USP is 5-[(3,5-dimethylphenoxy)methyl]-2-oxazolidinone. The empirical formula is C 12 H 15 NO 3 , which corresponds to a molecular weight of 221.25. The structural formula is: Metaxalone, USP is a white to almost white, crystalline powder freely soluble in dichloromethane, soluble in methanol, sparingly soluble in ethanol and ethyl acetate, slightly soluble in toluene and isopropanol, insoluble in water and n -hexane. Each tablet contains 400 mg metaxalone, USP and the following inactive ingredients: alginic acid, corn starch, ferric oxide red, copovidone, magnesium stearate, povidone, pregelatinized starch, sodium alginate. Metaxalone 800 mg - Chemical Structure

Nabumetone, USP is a naphthylalkanone designated chemically as 4-(6-methoxy-2- naphthalenyl)-2-butanone. Nabumetone is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2400 at pH 7.4. Each tablet, for oral administration contains either 500 mg or 750 mg of nabumetone. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxy propyl methyl cellulose, sodium lauryl sulphate, colloidal silicon dioxide and magnesium stearate. The 500 mg tablets also contain opadry white (Titanium dioxide, Hypromellose 3cP, Hypromellose 6cP, Macrogol and Polysorbate 80) and the 750 mg tablets contain opadry beige (Hypromellose 6cP, titanium dioxide, iron oxide yellow, iron oxide red and Macrogol). Structure

Nadolol is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-( tert -butylamino)-3-[(5, 6, 7, 8-tetrahydro- cis -6, 7-dihydroxy-1-naphthyl)oxy]-2-propanol. Structural formula: Nadolol, USP is a white crystalline powder. It is freely soluble in ethanol, soluble in hydrochloric acid, slightly soluble in water and in chloroform, and very slightly soluble in sodium hydroxide. Nadolol tablets, USP are available for oral administration as 20 mg, 40 mg, and 80 mg tablets. Inactive ingredients: lactose monohydrate, microcrystalline cellulose, povidone, D&C yellow No. 10, croscarmellose sodium, and magnesium stearate. image

Nicardipine hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride is a dihydropyridine derivative with IUPAC (International Union of Pure and Applied Chemistry) chemical name (±)-2-(benzyl-methyl amino) ethyl methyl 1,4-dihydro-2, 6-dimethyl-4- (m-nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride and has the following structure: Nicardipine hydrochloride is a pale greenish yellow powder that has a melting point range of 167-171°C. It is soluble in methanol and acetic acid, sparingly soluble in ethanol, slightly soluble in water. It has a molecular weight of 515.99. Nicardipine hydrochloride in 0.9% sodium chloride injection is available as a single-use, ready-to-use, iso-osmotic, clear, colorless to yellow solution for intravenous administration in a 200 mL single dose container. Each mL contains 0.1 mg or 0.2 mg nicardipine hydrochloride USP in 9 mg sodium chloride, USP. Hydrochloric acid (q.s.) may have been added to adjust pH to 3.5 to 4.7. structure

Nilotinib Capsules contains nilotinib d-tartrate, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib d-tartrate is a white to yellow powder with the molecular formula and weight, respectively, of C 32 H 28 F 3 N 7 O 7 and 679.61 g/mol (corresponding molecular formula and weight of nilotinib base, anhydrous are C 28 H 22 F 3 N 7 O and 529 g/mol, respectively). The solubility of nilotinib d-tartrate in aqueous solutions decreases with increasing pH. The pK a 1 of nilotinib d-tartrate was determined to be 4.0. The chemical name of nilotinib d-tartrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide D-Tartrate . Its structure is shown below: Nilotinib Capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib, anhydrous (equivalent to 64.172 mg, 192.517 mg, and 256.689 mg nilotinib d-tartrate, respectively). The inactive ingredients of Nilotinib Capsules are colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium aluminometasilicate, magnesium stearate, and polysorbate 80. The inactive ingredients in the empty capsules contain gelatin, iron oxide (black), iron oxide (red), iron oxide (yellow), and titanium dioxide. The black ink contains iron oxide (black), potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. structure

Omeprazole and sodium bicarbonate is a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2- [[(4-methoxy-3,5dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is C 17H 19N 3O 3S, with a molecular weight of 345.42. The structural formula is: Omeprazole, USP is a white or almost white powder which melts with decomposition at about 155°C. Soluble in dichloromethane, practically insoluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media but has acceptable stability under alkaline conditions. Omeprazole and sodium bicarbonate is supplied as immediate-release capsules. Each capsule contains either 40 mg or 20 mg of omeprazole and 1100 mg of sodium bicarbonate with the following excipients: croscarmellose sodium and sodium stearyl fumarate. The capsules consist of gelatin and titanium dioxide. In addition the 20 mg/1100 mg capsule shell contains sodium lauryl sulfate and the 40 mg/1100 mg capsule shell contains FD&C Blue 1. The capsules are printed with edible ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide, shellac and strong ammonia solution. Omeprazole and sodium bicarbonate capsules are immediate-release formulations that contain sodium bicarbonate which raises the gastric pH and thus protects omeprazole from acid degradation. STR

Oseltamivir phosphate, USP an influenza neuraminidase inhibitor (NAI), is available as a powder for oral suspension, which when constituted with water as directed contains 6 mg per mL oseltamivir base. In addition to the active ingredient, the powder for oral suspension contains colloidal silicon dioxide, monosodium citrate, saccharin sodium, sodium benzoate, sorbitol, titanium dioxide, tutti-frutti flavoring, and xanthan gum. Oseltamivir phosphate, USP is a white to off-white powder with the chemical name (3R,4R,5S)-4-acetylamino-5-amino-3(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester, phosphate (1:1). The chemical formula is C 16 H 28 N 2 O 4 (free base). The molecular weight is 312.4 for oseltamivir free base and 410.4 for oseltamivir phosphate salt. The structural formula is as follows: Oseltamivir phosphate_Structure

Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is paclitaxel formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers. Paclitaxel exists in the particles in a non‑crystalline, amorphous state. Paclitaxel is a microtubule inhibitor. The chemical name for paclitaxel is 5β,20-Epoxy- 1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2 R ,3 S )- N -benzoyl-3-phenylisoserine. The empirical formula is C 47 H 51 NO 14 and the molecular weight is 853.93. Paclitaxel has the following structural formula: Paclitaxel is a white to off-white crystalline powder. It is highly lipophilic, insoluble in water, and melts at approximately 206°C to 215°C. Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is supplied as a white to yellow, sterile, lyophilized cake or powder for reconstitution with 20 mL of 0.9% Sodium Chloride Injection, USP prior to intravenous infusion. Each single-dose vial contains 100 mg of paclitaxel, USP (semi-synthetic) (bound to human albumin) and approximately 900 mg of human albumin (containing sodium caprylate and sodium acetyltryptophanate). Each milliliter (mL) of reconstituted suspension contains 5 mg paclitaxel formulated as albumin-bound particles. Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is free of solvents. Image

Palonosetron Hydrochloride Injection is an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT 3 ) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3a S) -2-[( S )-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1 H benz[ de ]isoquinoline hydrochloride. The empirical formula is C 19 H 24 N 2 O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula: image Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Palonosetron Hydrochloride Injection is a sterile, clear, colorless, non pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron Hydrochloride Injection is available as 5 mL single use vial. Each 5 mL vial contains 0.25 mg palonosetron base as 0.28 mg palonosetron hydrochloride, 207.5 mg mannitol, disodium edetate and citrate buffer in water for intravenous administration. The pH of the solution in the 5 mL vials is 4.5 to 5.5. description

Phytonadione is a vitamin K replacement, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.70. Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is C 31 H 46 O 2 and its molecular structure is: Phytonadione Injectable Emulsion, USP injection is a yellow, sterile, aqueous colloidal solution of vitamin K 1 , with a pH of 3.5 to 7.0, available for injection by the intravenous, intramuscular, and subcutaneous routes. Phytonadione Injectable Emulsion, USP is available in 1 mg (1 mg/0.5 mL) single-dose pre-filled syringe. Each 0.5 mL of Phytonadione Injectable Emulsion, USP contains the following inactive ingredients: 0.125 mg L-cysteine hydrochloride monohydrate, 10 mg polysorbate 80, 10.4 mg propylene glycol, 0.17 mg sodium acetate anhydrous, and 0.00002 mL glacial acetic acid. Additional glacial acetic acid or sodium acetate anhydrous may have been added to adjust pH to meet USP limits of 3.5 to 7.0. The air above the liquid in the individual containers has been displaced by flushing with nitrogen during the filling operation. structure

Phytonadione is a vitamin K replacement, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.70. Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is C 31 H 46 O 2 and its molecular structure is: Phytonadione injectable emulsion, USP is a clear yellow, sterile, aqueous colloidal solution of vitamin K 1 , with a pH of 4.5 to 7.0, available for injection by the intravenous, intramuscular, and subcutaneous routes. Phytonadione injectable emulsion, USP is available in 1 mg (2 mg/mL) and 10 mg (10 mg/mL) single-dose vials. Each milliliter of phytonadione injectable emulsion, USP contains the following inactive ingredients: 70 mg polyoxyl 35 castor oil, 37.5 mg dextrose monohydrate, 9 mg benzyl alcohol (preservative), and water for injection. Phytonadione injectable emulsion, USP contains glacial acetic acid for pH adjustment to 6.3 (4.5 – 7.0). structure

Phytonadione is a vitamin K replacement, which is a clear, yellow to amber, viscous, and nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.7. Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is C 31 H 46 O 2 and its structural formula is: Phytonadione tablets, USP for oral administration contain 5 mg of phytonadione, USP and are pale yellow colored, round tablets, scored on one side. Inactive ingredients are acacia, anhydrous dibasic calcium phosphate, lactose monohydrate, magnesium stearate, pregelatinized starch, silicon dioxide and talc. Structure

Pirfenidone belongs to the chemical class of pyridone. Pirfenidone capsules is available as white opaque hard gelatin capsules containing 267 mg of pirfenidone for oral administration. Pirfenidone has a molecular formula of C 12 H 11 NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white or pale yellow, crystalline powder. It is sparingly soluble in water, freely soluble in ethanol (96%), very slightly soluble in heptane. The melting point is approximately 109°C. Pirfenidone capsules contain pirfenidone and the following inactive ingredients: silicified microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. In addition, the capsule shell contains gelatin, titanium dioxide and sodium lauryl sulfate. The capsule brown printing ink includes shellac glaze, n-butyl alcohol, isopropyl alcohol, ferroso ferric oxide/black iron oxide, iron oxide red, propylene glycol, iron oxide yellow and ammonium hydroxide. Chemical Structure

Pirfenidone belongs to the chemical class of pyridone. Pirfenidone is available as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone. Pirfenidone has a molecular formula of C 12 H 11 NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white or pale yellow, crystalline powder. It is sparingly soluble in water, freely soluble in ethanol (96%), very slightly soluble in heptane. The melting point is approximately 109°C. Pirfenidone tablets contain pirfenidone and the following inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, magnesium stearate, silicified microcrystalline cellulose, hypromellose, titanium dioxide, macrogol (polyethylene glycol). Additionally 267 mg tablets contain iron oxide yellow, iron oxide red and 801 mg tablets contain iron oxide yellow, iron oxide red, iron oxide black. pirfenidone

Potassium phosphates injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial. Monobasic Potassium Phosphate is chemically designated KH 2 PO 4 , molecular weight 136.09, white or colorless crystals or crystalline powder freely soluble in water. Dibasic Potassium Phosphate is chemically designated K 2 HPO 4 , molecular weight 174.18, colorless to white granular powder freely soluble in water. Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate. Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0. This product contains no more than 900 mcg/L of aluminum [ see Warnings and Precautions (5.5)] . The osmolarity is 7.4 mOsmol/mL (calc). The solution is administered after dilution or admixing by the intravenous route.

Pravastatin Sodium Tablets, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthaleneheptanoic acid, 1,2,6,7,8,8a-hexahydro-b,d,6-trihydroxy-2- methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula: Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin Sodium Tablets, USP for oral use contain 10 mg, 20 mg, 40 mg, and 80 mg pravastatin sodium, which is equivalent to 9.48 mg, 18.97 mg, 37.94 mg and 75.88 mg of pravastatin, respectively. Inactive ingredients include: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, mannitol, meglumine, microcrystalline cellulose and starch. The 10 mg, 20 mg and 80 mg tablets also contain D&C yellow no. 10 aluminum lake and the 40 mg tablet also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake. STRUCTURE

Pregabalin, USP is described chemically as ( S )-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8 H 17 NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is: Pregabalin, USP is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, USP along with pregelatinized starch, corn starch and talc as inactive ingredients. Capsule shells for 25 mg, 50 mg & 150 mg contains: gelatin & titanium dioxide Capsule shells for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: gelatin, FD&C Blue No.1, FD&C Red No.40, FD&C Yellow No.6 and titanium dioxide. Imprinting ink contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. Chemical Structure

Pregabalin is described chemically as ( S )-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8 H 17 NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is: Pregabalin is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with co-processed starch and talc as inactive ingredients. The capsule shell for 25 mg, 50 mg & 150 mg contains: gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule shell for 75 mg, 100 mg, 200 mg, 225 mg & 300 mg contains: FD &C Blue 1, FD& C Red 40, FD& C Yellow 6, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac. pregabalin

Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT 4 ) receptor agonist. The IUPAC name is: 4-amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydrobenzofuran-7-carboxamide succinate. The molecular formula is C 18 H 26 ClN 3 O 3 .C 4 H 6 O 4 and the molecular weight is 485.96. The structural formula is: Prucalopride succinate is a white to almost white powder. It is freely soluble in water, sparingly soluble in methanol and slightly soluble in N, N-Dimethyl acetamide Each film-coated tablet contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 1 mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide, and triacetin. Each film-coated tablet contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The coating for the 2 mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide, triacetin, red iron oxide. Prucalopride structure

Quinapril hydrochloride, USP is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochloride, USP is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C 25 H 30 N 2 O 5 •HCl and its structural formula is: Quinapril hydrochloride, USP is a white to off-white amorphous powder that is freely soluble in aqueous solvents. Quinapril tablets, USP contain quinapril hydrochloride equivalent to 5 mg, 10 mg, 20 mg, or 40 mg of quinapril for oral administration. Each tablet also contains lactose monohydrate, magnesium carbonate, magnesium stearate, crospovidone, povidone and opadry brown (hypromellose, titanium dioxide, iron oxide and macrogol). Image

Quinapril and hydrochlorothiazide tablets, USP are fixed-combination tablet that combines an angiotensin-converting enzyme (ACE) inhibitor, quinapril hydrochloride, and a thiazide diuretic, hydrochlorothiazide. Quinapril hydrochloride, USP is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C 25 H 30 N 2 O 5 . HCl and its structural formula is: Quinapril hydrochloride, USP is a white to off-white amorphous powder that is freely soluble in aqueous solvents. Hydrochlorothiazide, USP is chemically described as: 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7 H 8 CIN 3 O 4 S 2 and its structural formula is: Hydrochlorothiazide, USP is a white to off-white, crystalline powder which is slightly soluble in water but freely soluble in sodium hydroxide solution. Quinapril and hydrochlorothiazide tablets, USP are available for oral use as fixed combination tablets in three strengths of quinapril with hydrochlorothiazide: 10 mg with 12.5 mg (quinapril and hydrochlorothiazide 10/12.5), 20 mg with 12.5 mg (quinapril and hydrochlorothiazide 20/12.5), and 20 mg with 25 mg (quinapril and hydrochlorothiazide 20/25). Inactive ingredients: lactose, magnesium carbonate, crospovidone, povidone, magnesium stearate and opadry pink 03B14436 (hypromellose, titanium dioxide, polyethylene glycol and iron oxide red). image image

Raloxifene hydrochloride, USP is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is: The chemical designation is methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl]-[4-[2-(1-piperidinyl) ethoxy]phenyl]-, hydrochloride. Raloxifene hydrochloride (HCl) has the empirical formula C 28 H 27 NO 4 S•HCl, which corresponds to a molecular weight of 510.05. Raloxifene HCl, USP is an off-white to pale-yellow solid that is very slightly soluble in water. Raloxifene hydrochloride tablets, USP are supplied in a tablet dosage form for oral administration. Each raloxifene hydrochloride tablet contains 60 mg of raloxifene HCl, USP which is the molar equivalent of 55.71 mg of free base. Inactive ingredients include mannitol, crospovidone, hydroxypropyl cellulose, poloxamer 407, magnesium stearate and opadry white (titanium Dioxide, hypromellose 2910 (3cP), hypromellose 2910 (6cP), macrogol/PEG 400 and polysorbate 80). Image

Ritonavir is an inhibitor of HIV protease with activity against the Human Immunodeficiency Virus (HIV). Ritonavir is chemically designated as 2,4,7,12-Tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C 37 H 48 N 6 O 5 S 2 , and its molecular weight is 720.94. Ritonavir has the following structural formula: Ritonavir USP is a white to almost white powder. It is freely soluble in methanol and in methylene chloride, very slightly soluble in acetonitrile, practically insoluble in water. Ritonavir Tablets USP are available for oral administration containing 100 mg ritonavir USP and the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, copovidone, hypromellose, isopropyl alcohol, polysorbate 80, polyethylene glycol, purified water, sodium stearyl fumarate, sorbitan monolaurate, and titanium dioxide. Image