torrent pharmaceuticals limited - Medication Listings

Montelukast sodium, the active ingredient in montelukast sodium tablets USP and montelukast sodium oral granules USP, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor. Montelukast sodium is described chemically as [ R-(E) ]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl] cyclopropaneacetic acid, monosodium salt. The empirical formula is C 35 H 35 ClNNaO 3 S, and its molecular weight is 608.18. The structural formula is: Montelukast sodium is a hygroscopic, optically active, white to off-white powder. Montelukast sodium is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile. Each 10-mg film-coated montelukast sodium tablet USP contains 10.4 mg montelukast sodium, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: croscarmellose sodium, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and titanium dioxide. Each 4-mg and 5-mg chewable montelukast sodium tablet USP contains 4.2 and 5.2 mg montelukast sodium, respectively, which are equivalent to 4 and 5 mg of montelukast, respectively. Both chewable tablets contain the following inactive ingredients: aspartame, cellulose microcrystalline, cherry flavor, croscarmellose sodium, ferric oxide red, magnesium stearate, mannitol. Each packet of Montelukast sodium oral granules USP 4 mg contains 4.16 mg Montelukast sodium USP, which is equivalent to 4 mg of montelukast. The oral granule formulation contains the following inactive ingredients: mannitol, hydroxypropyl cellulose, tribasic sodium phosphate and magnesium stearate. str

The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl] -1 H -benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C 16 H 14 F 2 N 3 NaO 4 S x 1.5 H 2 O, with a molecular weight of 432.4. The structural formula is: Pantoprazole sodium sesquihydrate, USP is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate, USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.56 mg of pantoprazole sodium) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium). Pantoprazole sodium delayed-release tablet, USP contains the following inactive ingredients: calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid copolymer dispersion, propylene glycol, sodium carbonate, talc, titanium dioxide, and triethyl citrate. Pantoprazole sodium delayed-release tablets, USP (40 mg and 20 mg) complies with USP dissolution test 3. structure

Trazodone hydrochloride tablets for oral administration contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4,3-a]pyridin-3(2 H )-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows: Molecular Formula: C 19 H 2 2 ClN 5 O · HCl Molecular Weight: 408.33 Each tablet, for oral administration, contains 50 mg, 100 mg, 150 mg or 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, sodium lauryl sulfate, and sodium starch glycolate. strucure

The active ingredient in esomeprazole magnesium for delayed-release oral suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H- benzimidazole-1-yl) magnesium, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17 H 18 N 3 O 3 S) 2 Mg with molecular weight of 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored crystalline powder. The stability of esomeprazole magnesium USP is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium for delayed-release oral suspension is supplied in packets. Each packet of esomeprazole magnesium for delayed-release oral suspension contains esomeprazole, in the form of enteric-coated pellets, and also inactive granules. 10 mg esomeprazole (equivalent to 10.353 mg esomeprazole magnesium USP) The inactive granules are composed of the following ingredients: citric acid monohydrate, colloidal silicon dioxide, crospovidone, dextrose monohydrate, ferric oxide yellow, hydroxy propyl cellulose and xanthan gum. Esomeprazole 10 mg pellets contains following ingredients: ethyl cellulose, magnesium oxide (light), magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, mono and diglycerides, polysorbate 80, povidone, sugar spheres 60-80 mesh, talc and triethyl citrate. The esomeprazole pellets and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration. Image

The active ingredient in esomeprazole magnesium for delayed-release oral suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole-1-yl) magnesium, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C 17 H 18 N 3 O 3 S) 2 Mg with molecular weight of 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored crystalline powder. The stability of esomeprazole magnesium USP is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium for delayed-release oral suspension is supplied in packets. Each packet of Esomeprazole magnesium for delayed-release oral suspension contains esomeprazole magnesium USP equivalent to esomeprazole 2.5 mg, 5 mg, 20 mg, or 40 mg, in the form of enteric-coated pellets. Each packet of esomeprazole magnesium for delayed-release oral suspension contains esomeprazole, in the form of enteric-coated pellets, and also inactive granules: 2.5 mg esomeprazole (equivalent to 2.588 mg esomeprazole magnesium USP) 5 mg esomeprazole (equivalent to 5.176 mg esomeprazole magnesium USP) 20 mg esomeprazole (equivalent to 20.706 mg esomeprazole magnesium USP) 40 mg esomeprazole (equivalent to 41.411 mg esomeprazole magnesium USP) The inactive granules are composed of the following ingredients: citric acid monohydrate, colloidal silicon dioxide, crospovidone, dextrose monohydrate, ferric oxide yellow, hydroxy propyl cellulose and xanthan gum. Esomeprazole 2.5 mg, 5 mg, 20 mg, and 40 mg pellets contains following ingredients: ethyl cellulose, magnesium oxide (light), magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, mono and diglycerides, polysorbate 80, povidone, sugar spheres 60-80 mesh, talc and triethyl citrate. The esomeprazole pellets and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration. Image

Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib, USP for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzene sulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17 H 14 F 3 N 3 O 2 S, and it has the following chemical structure: Celecoxib, USP is a white or almost white, crystalline powder with a pKa of 11. Celecoxib is freely soluble in ethanol, soluble in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsule include: croscarmellose sodium, lactose monohydrate DCL 11, magnesium stearate, povidone (K 30) and sodium lauryl sulfate. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, 50 mg capsule shell contain iron oxide red, 100 mg capsule shell contain FD&C blue 1 and FD&C red 40, 200 mg capsule shell contain iron oxide yellow and 400 mg capsule shell contain FD&C blue 2 and iron oxide yellow. The imprinting ink contains iron oxide black, propylene glycol, potassium hydroxide, povidone, shellac, sodium hydroxide and titanium dioxide. structure

Fluoxetine tablets, USP are a selective serotonin reuptake inhibitor (SSRI) for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p -tolyl)oxy]propylamine hydrochloride and has the empirical formula of C 17 H 18 F 3 NO•HCl. Its molecular weight is 345.79. The structural formula is: Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each Fluoxetine tablets, USP contains fluoxetine hydrochloride equivalent to 10 mg or 20 mg of fluoxetine. Each tablet also contains colloidal silicon dioxide, croscarmellose sodium, D&C yellow no. 10 lake, FD&C yellow no. 6 lake, magnesium stearate, microcrystalline cellulose, and povidone. Structure

Clopidogrel tablets, USP are a thienopyridine class inhibitor of P2Y 12 ADP platelet receptors. Chemically it is methyl (+)-( S )-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5( 4H )acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C 16 H 16 ClNO 2 S•H 2 SO 4 and its molecular weight is 419.9. The structural formula is as follows: Clopidogrel bisulfate, USP is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Clopidogrel tablets, USP for oral administration are provided as light pink colored, round, beveled edge, biconvex, film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base. Each tablet contains colloidal silicon dioxide, hydrogenated castor oil, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose and polyethylene glycol 6000 as inactive ingredients. The light pink film coating contains ferric oxide red, hypromellose 2910, and titanium dioxide. str

Rosuvastatin calcium USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium USP is 6-Heptenoic acid, 7-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl) amino]-5-pyrimidinyl]-3,5-dihydroxy-, calcium salt (2:1), (3R,5S,6E) with the following structural formula: The empirical formula for rosuvastatin calcium USP is (C 22 H 27 FN 3 O 6 S) 2 Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a White or almost white, hygroscopic powder that is freely soluble in methylene chloride, slightly soluble in water practically insoluble in anhydrous ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: Each tablet contains: crospovidone, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate powder, titanium dioxide, triacetin. structural_formula

Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium USP is bis[(E)-7-[4- (4-fluorophenyl)-6-isopropyl-2 [methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S) -3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The empirical formula for rosuvastatin calcium USP is (C 22 H 27 FN 3 O 6 S) 2 Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: Each tablet contains: crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. Additionally, the 5 mg tablet contains ferric oxide yellow and the 10 mg, 20 mg and 40 mg tablets contain ferric oxide red. Structure

Sildenafil tablets, USP, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA ® for erectile dysfunction. Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H -pyrazolo [4,3- d ] pyrimidin-5-yl)-4- ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil Tablets USP: Sildenafil citrate is formulated as white, film-coated round tablets for oral administration. Each tablet contains sildenafil citrate equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, microcrystalline cellulose, sodium stearyl fumarate, titanium dioxide and triacetin. 1

Sildenafil tablets USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H -pyrazolo [4,3- d ] pyrimidin-5-yl)-4- ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil Citrate USP is formulated as blue, round, biconvex, film-coated tablets containing sildenafil citrate equivalent to 25 mg, 50 mg or 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lake of indigo carmine, microcrystalline cellulose, sodium stearyl fumarate, titanium dioxide and triacetin. chemical-structure

Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3­dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula: The molecular formula is C 20 H 22 BrFN 2 O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, corn starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. image description

Donepezil hydrochloride USP is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1 H -inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020. It has an empirical formula of C 24 H 29 NO 3 HCl and a molecular weight of 415.96. Donepezil hydrochloride, USP is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in n-hexane. Donepezil hydrochloride is available for oral administration in film-coated tablets containing 5 or 10 mg of donepezil hydrochloride, USP. Inactive ingredients in 5 mg and 10 mg tablets are lactose monohydrate, magnesium stearate, maize starch ( Zea mays ) and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Additionally, the 10 mg tablet contains ferric oxide red and ferric oxide yellow as coloring agents. str

Escitalopram tablets contain escitalopram, a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S- enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1- [3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula: The molecular formula is C 20 H 21 FN 2 O • C 2 H 2 O 4 and the molecular weight is 414.40. Escitalopram oxalate, USP occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram tablets, USP are white to off-white, round, biconvex, film-coated tablets containing 6.38 mg, 12.75 mg and 25.55 mg escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively, of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: cellulose microcrystalline, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, povidone and talc. The film coating contains hypromellose, polyethylene glycol 400 and titanium dioxide. Meets USP Dissolution Test 2. 1

Acyclovir ointment, USP 5% is a synthetic nucleoside analogue active against herpes viruses. Acyclovir ointment, USP 5% is a formulation for topical administration. Each gram of Acyclovir ointment, USP 5% contains 50 mg of acyclovir USP in a polyethylene glycol (PEG) base. Acyclovir is a white, crystalline powder with the molecular formula C 8 H 11 N 5 O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9- [(2-hydroxyethoxy)methyl]-6 H- purin-6-one; it has the following structural formula: Acyclovir Structure VIROLOGY: Mechanism of Antiviral Action : Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro , acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities: The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC 50 ), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC 50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC 50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC 50 of 1.35 mcg/mL. Drug Resistance: Resistance of HSV and VZV to acyclovir can result from qualitative or quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy.

Anagrelide hydrochloride, USP is a platelet-reducing agent. Its chemical name is 6,7-dichloro-1,5 dihydroimidazo[2,1-b] quinazolin-2(3H)-one monohydrochloride monohydrate and it has the following structural formula: C 10 H 7 Cl 2 N 3 O·HCl·H 2 O M.W. 310.56 Anagrelide hydrochloride, USP is a white to off white powder that is practically insoluble in water and slightly soluble in dimethyl sulfoxide and very slightly soluble in dimethylformamide. Each Anagrelide Capsule USP, for oral administration, contains either 0.5 mg or 1 mg of anagrelide as anagrelide hydrochloride, USP and has the following inactive ingredients: black iron oxide, gelatin, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, hydroxypropyl cellulose, propylene glycol, shellac and titanium dioxide, potassium hydroxide. Image

Aprepitant capsules, USP contain the active ingredient, aprepitant, USP. Aprepitant, USP is a substance P/neurokinin 1 (NK 1 ) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2 R ,3 S )-2-[(1 R )-1-[3,5bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3 H -1,2,4-triazol-3one. Its empirical formula is C 23 H 21 F 7 N 4 O 3 , and its structural formula is: Aprepitant, USP is a white to off-white powder, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in alcohol and slightly soluble in acetonitrile. Each capsule of aprepitant for oral administration contains either 40 mg, 80 mg, or 125 mg of aprepitant, USP and the following inactive ingredients: hypromellose 2910, poloxamer 407, sucrose, microcrystalline cellulose and imprinting ink (shellac glaze, iron oxide black and propylene glycol). The capsule shell excipients are gelatin, titanium dioxide and sodium lauryl sulfate. The 40-mg capsule shell also contains yellow ferric oxide, sodium lauryl sulfate and titanium dioxide, 80-mg capsule shell contains sodium lauryl sulfate and titanium dioxide and the 125-mg capsule contains red ferric oxide, sodium lauryl sulfate and titanium dioxide. Meets USP Dissolution Test 2. Structural formula

Aripiprazole, USP is an atypical antipsychotic drug that is available as aripiprazole tablets, USP. Aripiprazole, USP is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl] butoxy]-3,4-dihydrocarbostyril. The empirical formula is C 23 H 27 Cl 2 N 3 O 2 and its molecular weight is 448.38. The chemical structure is: Aripiprazole tablets, USP are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, magnesium stearate, mannitol and microcrystalline cellulose. Additionally, 2 mg tablets contain ferric oxide yellow. description image

Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as extended-release tablets of 100, 200, and 400 mg. Its chemical name is 5 H -dibenz[ b,f ]azepine-5-carboxamide, and its structural formula is: Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients Tablets : Cellulose acetate (CA-320S), cellulose acetate (CA-398-10), dextrates (milled), ferric oxide red (200 mg and 400 tablets only), ferric oxide yellow (100 mg and 400 mg tablets only), hydroxyethyl cellulose (natrosol 250 HX), hydroxyethyl cellulose (natrosol 250L), hypromellose E 15 LV, hypromellose-3 cps, magnesium stearate, mannitol 25, polyethylene glycol 8000, sodium lauryl sulfate, titanium dioxide (200 mg tablets only). The imprinting ink contains ferrosoferric oxide, propylene glycol and shellac. FDA approved dissolution test specifications differ from USP. Image

Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as chewable tablets of 100 mg and tablets of 200 mg. Its chemical name is 5H -dibenz[ b,f ]azepine-5-carboxamide, and its structural formula is: Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Carbamazepine tablets, USP, 200 mg contain the inactive ingredients: colloidal silicon dioxide, FD&C Red #40 aluminum lake, hypromellose, magnesium stearate, pregelatinized maize starch, corn starch, and sodium starch glycolate. Carbamazepine tablets, USP, (chewable) contain the inactive ingredients: artificial flavors, colloidal silicon dioxide, compressible sugar, corn starch, FD&C Red #40 aluminum lake, hydroxypropyl methyl cellulose, magnesium stearate, and sodium starch glycolate. Carbamazepine tablets, USP, 200 mg meet USP Dissolution Test 2 and Carbamazepine Tablets USP (Chewable), 100 mg meet USP Dissolution Test 1. Structural Formula

Clobetasol propionate cream, USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11ß, 16ß)-21-chloro-9- fluoro-11-hydroxy-16-methyl-17-(1- oxopropoxy)-pregna-1, 4- diene-3, 20-dione, and it has the following structural formula: Clobetasol propionate has the empirical formula C 25 H 32 ClFO 5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base of cetyl alcohol, citric acid anhydrous, glycol stearate, lanolin oil, methylparaben, polyoxyl 8 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearyl alcohol, and white petrolatum (white soft paraffin). Sodium hydroxide may be used to adjust pH. Image

Dapsone Gel, 7.5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. Dapsone Gel, 7.5% is an off-white to yellow color homogeneous gel with suspended particles, no phase separation and sedimentation, free of lumps and foreign matter. Chemically, dapsone has an empirical formula of C 12 H 12 N 2 O 2 S. It is a white to creamy white crystalline powder that has a molecular weight of 248.30. Dapsone's chemical name is 4-[(4'-aminobenzene) sulfonyl] aniline and its structural formula is: Each gram of dapsone gel, 7.5% contains 75 mg of dapsone, USP in a gel of carbomer homopolymer type C, diethylene glycol monoethyl ether, methylparaben, sodium hydroxide and purified water. structure

Darifenacin extended-release tablet is an extended-release tablet for oral administration which contains 7.5 mg or 15 mg darifenacin as its hydrobromide salt. The active moiety, darifenacin, is a potent muscarinic receptor antagonist. Chemically, darifenacin hydrobromide is (S) -2-{1-[2-(2,3-dihydrobenzofuran-5-yl)ethyl]-3-pyrrolidinyl}-2,2-diphenylacetamide hydrobromide. The empirical formula of darifenacin hydrobromide is C 28 H 30 N 2 O 2 •HBr. The structural formula is: Darifenacin hydrobromide is a white to almost white to off-white powder, with a molecular weight of 507.5. Darifenacin extended-release tablet is a once-a-day extended-release tablet and contains the following inactive ingredients: colloidal silicon dioxide, hypromellose (E15 LV), hypromellose (methocel K4M CR), magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, talc and titanium dioxide. The 15 mg tablet also contains ferric oxide red and ferric oxide yellow. structure

Dichlorphenamide tablets USP contain dichlorphenamide, an oral carbonic anhydrase inhibitor. Dichlorphenamide USP, a dichlorinated benzenedisulfonamide, is known chemically as 4, 5–dichloro- 1,3-benzenedisulfonamide. Its empirical formula is C 6 H 6 Cl 2 N 2 O 4 S 2 and its structural formula is: Dichlorphenamide USP is a white or practically white, crystalline powder with a molecular weight of 305.16. It is very slightly soluble in water but soluble in dilute solutions of alkali carbonate and hydroxide. Dichlorphenamide tablets USP are supplied as tablets, for oral administration, each containing 50 mg dichlorphenamide USP. Inactive ingredients are lactose monohydrate, partially pregelatinized starch and magnesium stearate. FDA Approved dissolution test specifications differ from USP. image description

Diclofenac potassium for oral solution, USP is a nonsteroidal anti-inflammatory drug, available as a buffered soluble powder, designed to be mixed with water prior to oral administration. Diclofenac potassium for oral solution, USP is a white to pale yellow, buffered, flavored powder for oral solution packaged in individual unit dose packets. The chemical name is potassium [2-(2,6-dichlorophenyl)amino] phenyl]acetate. The molecular weight is 334.24. Its molecular formula is C 14 H 10 Cl 2 NKO 2 , and it has the following structure. The inactive ingredients in diclofenac potassium for oral solution include: mannitol, povidone, sucralose, potassium bicarbonate, peppermint flavor, glyceryl dibehenate. structure

Erythromycin delayed-release tablets are an antibacterial product containing erythromycin base in a specially enteric-coated tablet. The coating protects the antibiotic from the inactivating effects of gastric acidity and permits efficient absorption of the antibiotic in the small intestine. Erythromycin delayed-release tablets for oral administration are available in three dosage strengths, each white to off white oval tablet containing 250 mg, 333 mg and 500 mg of erythromycin as the free base. Erythromycin delayed-release tablets comply with USP Dissolution Test 1 . Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus ) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, freely soluble in alcohol and soluble in methanol. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*,13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3- dimethylamino)-β-D-xylo-hexopyranosyl]oxy] oxacyclotetradecane-2,10-dione. The molecular formula is C 37 H 67 NO 13 , and the molecular weight is 733.93. The structural formula is: chemical-structure Inactive Ingredients Calcium silicate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, mannitol, methacrylic acid and ethyl acrylate copolymer, poloxamer 407, polyethylene glycol, pregelatinized maize starch, sodium bicarbonate, sodium citrate, sodium lauryl sulphate, talc and titanium dioxide.

Erythromycin tablets, USP are an antibacterial product containing erythromycin, USP in a unique, nonenteric film coating for oral administration. Erythromycin tablets are available in two strengths containing 250 mg or 500 mg erythromycin base. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus ) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L- ribo -hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)- β-D- xylo –hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C 37 H 67 NO 13 , and the molecular weight is 733.94. The structural formula is: chemical-structure Inactive Ingredients Colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, magnesium stearate, mannitol, pregelatinized maize starch, sodium citrate, talc, calcium silicate, methacrylic acid & ethyl acetate copolymer, poloxamer, sodium bicarbonate, sodium lauryl sulfate, titanium dioxide.

The chemical name of eslicarbazepine acetate, USP is (S)-10-Acetoxy-10,11-dihydro-5H dibenz[b,f]azepine-5-carboxamide. Eslicarbazepine acetate, USP is 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 296.32. The chemical structure is: Eslicarbazepine acetate, USP is a white to almost white crystalline Powder. It is Freely soluble in Dimethylsulphoxide and Dichloromethane. Each eslicarbazepine acetate tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate, USP and the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and povidone (K-30). image description

Felodipine is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ± ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2, 6-dimethyl-3,5-pyridinedicarboxylate. Its molecular formula is C 18 H 19 Cl 2 NO 4 and its structural formula is: Felodipine, USP is a light yellow to yellow crystalline powder with a molecular weight of 384.26. It is insoluble in water and is freely soluble in acetone and in methanol; very slightly soluble in heptane. Felodipine is a racemic mixture. Felodipine extended-release tablets provide extended release of felodipine. They are available as tablets containing 2.5 mg, 5 mg or 10 mg of felodipine, USP for oral administration. Inactive ingredients are: colloidal silicon dioxide, hydroxy propyl cellulose, hypromellose, lactose anhydrous, magnesium oxide, microcrystalline cellulose, polyoxyl 40 hydrogenated castor oil, propyl gallate, propylene glycol, sodium stearyl fumarate, talc, titanium dioxide and additional agents listed below: 2.5 mg tablets: Ferric oxide yellow and lake of indigo carmine 5 and 10 mg tablets: Ferric oxide red and ferric oxide yellow Meets USP Dissolution Test 3. str

Fenofibrate Capsules, USP are a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate. The chemical name for fenofibrate is Isopropyl 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 is very soluble in methylene chloride, slightly soluble in alcohol and practically insoluble in water. The melting point is 79 to 82°C. Fenofibrate is a white or almost white, crystalline powder which is stable under ordinary conditions. For 200 mg strength: Meets USP Dissolution Test 6. Inactive Ingredients: Each capsule contains colloidal silicon dioxide, crospovidone type B, lactose monohydrate, magnesium stearate, pregelatinized starch (modified corn starch), sodium lauryl sulphate and sodium stearyl fumarate. Ingredients of capsule shells: Each capsule contains FD & C Red 40, FD & C Blue 1, Gelatin, Iron Oxide Red, Iron Oxide Yellow, Polyethylene Glycol, Sodium Lauryl Sulphate, Titanium Dioxide. Ingredients of printing ink: Black iron oxide-E172, Potassium hydroxide-E525, Propylene glycol-E1520 and Shellac-E904. Image

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. Fidaxomicin tablets are film-coated and contain 200 mg of fidaxomicin per tablet and the following inactive ingredients: butylated hydroxyl toluene, hydroxypropyl cellulose, lecithin (soya), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, sodium starch glycolate, talc and titanium dioxide. figure-1

Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Each tablet, for oral administration, contains either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, diethyl phthalate, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc and titanium dioxide. The molecular formula of ISMN is C 6 H 9 NO 6 and the molecular weight is 191.14. The chemical name for ISMN is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula: ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +144° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, ethanol, methanol, chloroform, ethyl acetate, and dichloromethane. For 30 mg: Meets USP Dissolution Test 6. For 60 mg and 120 mg: Meets USP Dissolution Test 1. chemical-structure

Itraconazole, USP is an azole antifungal agent. Itraconazole is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by the following structural formula and nomenclature: 3 H -1,2,4-Triazol-3-one,4-[4-[4-[4-[[2-(2,4-dichlorophenyl)-2-(1 H -1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-4-dihydro-2-(1-methylpropyl)- or (±)-1- sec -Butyl-4-[ p -[4-[ p -[[(2 R *,4 S *)-2-(2,4-dichlorophenyl)-2-(1 H -1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ 2 -1,2,4-triazolin-5-one Itraconazole USP has a molecular formula of C 35 H 38 Cl 2 N 8 O 4 and a molecular weight of 705.63. It is a white or almost white powder. It is practically insoluble in water, very slightly soluble in alcohol, freely soluble in methylene chloride, and sparingly soluble in tetrahydrofuran. It has a pKa of 3.7* (* Merck Index, Fifteenth Edition ) and a log (n-octanol/water) partition coefficient of 5.66 at pH 8.1. Itraconazole capsules, USP contain 100 mg of itraconazole, USP coated on sugar spheres (composed of maize starch and sucrose). Inactive ingredients are hard gelatin capsule, hypromellose, polyethylene glycol, sugar spheres & talc. In addition, the blue opaque capsule shell contains FD&C Blue No. 1, FD&C Blue No. 2, gelatin & titanium dioxide and the pink transparent body contains D&C Red No. 28 & gelatin. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac. Meets USP Dissolution Test 2. structural formula

Lamotrigine extended-release tablets, USP (lamotrigine), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as -triazine, its molecular formula is C 9 H 7 N 5 Cl 2 , and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pK a of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is: Lamotrigine extended-release tablets, USP are supplied for oral administration as 25-mg (light yellow to yellow), 50-mg (light green to green), 100-mg (light orange to orange), and 200-mg (light blue to blue) tablets. Each tablet contains the labeled amount of lamotrigine, USP and the following inactive ingredients: diethyl phthalate, ferric oxide black (50-mg tablet only), ferric oxide red (100-mg tablet only), ferric oxide yellow (25-mg, 50-mg and 100-mg tablets only), hypromellose, hypromellose phthalate, lactose monohydrate, lake of indigo carmine (200-mg tablet only), magnesium stearate, polyethylene glycol, talc, titanium dioxide. Lamotrigine extended-release tablets, USP contain a modified-release eroding formulation as the core. The tablets are coated with polymer to prevent release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. Meets USP Dissolution Test 3 1

Lamotrigine USP, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as -triazine, its molecular formula is C 9 H 7 N 5 Cl 2 , and its molecular weight is 256.09. Lamotrigine USP is a white to off white powder and has a pKa of 5.7. Lamotrigine USP is soluble in dimethylformamide, slightly soluble in acetone, in methanol and in acetic acid, very slightly soluble in acetonitrile. The structural formula is: Lamotrigine orally disintegrating tablets, USP are supplied for oral administration. The tablets contain 25 mg (white to off-white), 50 mg (white to off-white), 100 mg (white to off-white), or 200 mg (white to off-white) of lamotrigine, USP and the following inactive ingredients: mannitol, colloidal silicon dioxide, amino methacrylate copolymer, stearic acid, magnesium stearate, microcrystalline cellulose, croscarmellose sodium, crospovidone, peppermint flavor, sucralose. Lamotrigine orally disintegrating tablets, USP are formulated using in-house technologies designed to mask the bitter taste of lamotrigine. The formulation contains flavor and sweetener and has a good mouth feel, no grittiness, no after taste, better palatability and gives a rapid dissolution profile. FDA approved dissolution test specifications differ from USP. structure

Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)- as -triazine, its molecular formula is C 9 H 7 N 5 Cl 2 , and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pK a of 5.7. Lamotrigine, USP is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is: Lamotrigine tablets, USP are supplied for oral administration as 25-mg (white to off white), 100-mg (white to off white), 150-mg (white to off white), and 200-mg (white to off white) tablets. Each tablet contains the labeled amount of lamotrigine, USP and the following inactive ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; povidone; and sodium starch glycolate. Meets USP Dissolution Test 3 Structure

Levetiracetam extended-release tablets, USP are an antiepileptic drug available as 500 mg and 750 mg (white) extended-release tablets for oral administration. The chemical name of levetiracetam, USP a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8 H 14 N 2 O 2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.) Levetiracetam extended-release tablets, USP contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, copovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400 and titanium dioxide. The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. Meets USP Dissolution Test 4. image description

Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1,000 mg (white) tablets. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8 H 14 N 2 O 2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.) Levetiracetam tablets, USP contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, polyethylene glycol 400, povidone, sodium starch glycolate, talc, titanium dioxide, and additional agents listed below: 250 mg tablets: FD&C Blue #2 Lake of indigo carmine 500 mg tablets: Ferric oxide yellow 750 mg tablets: Ferric oxide red and FD&C #6 lake of sunset yellow Meets USP Dissolution Test 3. str

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 highly soluble in methanol, very slightly soluble in isopropyl alcohol and ethyl acetate, sparingly soluble in dimethylformamide and insoluble in toluene. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 60 mg of lurasidone hydrochloride. Inactive ingredients are croscarmellose sodium, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, polyethylene glycol and titanium dioxide. structure

Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis (dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is: Each minocycline hydrochloride capsule, USP for oral administration contains the equivalent of 50 mg, 75 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and titanium dioxide. The 75 mg and 100 mg capsule shells also contain black iron oxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, and shellac. description

Minocycline hydrochloride, USP is a semisynthetic derivative of tetracycline, 4,7- Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is: Minocycline hydrochloride tablets, USP for oral administration, contains minocycline hydrochloride, USP equivalent to 50 mg, 75 mg or 100 mg of minocycline. In addition, each film-coated tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol 6000, silicified microcrystalline cellulose, stearic acid, and titanium dioxide. chemical-structure

Mometasone Furoate Ointment USP, 0.1% contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate is 9a,21-dichloro-11b,17-dihydroxy-16a-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C 27 H 30 Cl 2 O 6 , a molecular weight of 521.4 and the following structural formula: Mometasone furoate is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol. Each gram of Mometasone Furoate Ointment USP, 0.1% contains 1 mg mometasone furoate in a white to off-white uniform ointment base of hexylene glycol, phosphoric acid, propylene glycol stearate (55% monoester), purified water, white wax, and white petrolatum. Structure

The chemical name for the active ingredient in nebivolol tablets is (1RS,1'RS)-1,1'-[(2RS,2'SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2'-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol's molecular formula is (C 22 H 25 F 2 NO 4 •HCl) with the following structural formula: Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: cellulose microcrystalline, croscarmellose sodium, D&C Red #27 (10 mg only), FD&C Blue #2 Lake, FD&C Yellow #6 Lake (5 mg only), hypromellose, lactose monohydrate, magnesium stearate, pregelatinized maize starch and maize starch. Image Image

Nilotinib capsule contains nilotinib, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib drug substance, in the form of monohydrochloride monohydrate, is a white to slightly yellowish to slightly greenish yellow powder with the molecular formula and weight, respectively, of C 28 H 22 F 3 N 7 O•HCl • H 2 O and 584 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 in aqueous solutions decreases with increasing pH. Nilotinib is not optically active. The pK a 1 was determined to be 2.1; pK a 2 was estimated to be 5.4. The chemical name of nilotinib monohydrochloride monohydrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide, monohydrochloride, monohydrate. Its structure is shown below: Nilotinib capsules, for oral use, contain 150 mg, or 200 mg nilotinib base, anhydrous (equivalent to 166 mg and 221 mg nilotinib monohydrochloride monohydrate respectively) with the following inactive ingredients: colloidal silicone dioxide, crospovidone, lactose monohydrate, magnesium stearate and poloxamer 188. The capsule shell for 150 mg and 200 mg contains gelatin, iron oxide (yellow) and titanium dioxide. Additionally, the capsule shell for 150 mg contains iron oxide red. The black imprinting ink for 150 mg contains iron oxide (black), potassium hydroxide, propylene glycol and shellac. The red imprinting ink for 200 mg contains FD&C Red No. 40 aluminum lake, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Image

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Structural formula: Molecular formula : C 47 H 75 NO 17 Molecular weight : 926.09 g/mol Nystatin cream is for dermatologic use. Nystatin cream, USP for topical use, contains 100,000 USP nystatin units per gram. Inactive ingredients: aluminium hydroxide gel, ceteareth-15, mono- and di- glyceride, polyoxyl 8 stearate, propylene glycol, simethicone emulsion, sorbitol solution, titanium dioxide, white petrolatum, methylparaben and propylparaben. Image

Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei. Structural formula: Molecular formula : C 47 H 75 NO 17 Molecular weight : 926.09 g/mol Nystatin ointment is for dermatologic use. Nystatin ointment for topical use contains 100,000 USP nystatin units per gram in an ointment base of light mineral oil and white petrolatum. Image

Nystatin and triamcinolone acetonide cream USP for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin USP is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder. Is hygroscopic and is affected by long exposure to light, heat and air. freely soluble in dimethylformamide and in dimethyl sulfoxide; very slightly soluble in methanol, practically insoluble or insoluble in water in alcohol, in n-propyl alcohol, in n-butyl alcohol, in chloroform and in ether. Structural formula: Molecular formula : C 47 H 75 NO 17 Molecular weight : 926.13 Triamcinolone acetonide USP is designated chemically as 9-fluoro-11ß, 16α, 17, 21-tetrahydroxy pregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder having not more than a slight odour, is practically insoluble in water, and sparingly soluble in dehydrated alcohol, in chloroform, and in methanol. Structural formula: Molecular formula : C 24 H 31 FO 6 Molecular weight : 434.50 Nystatin and triamcinolone acetonide cream USP is a soft, smooth cream having a light yellow to buff color. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an aqueous cream base containing aluminium hydroxide gel, ceteareth-15, methylparaben, mono- and di- glycerides, polyoxyl 8 stearate, polysorbate 60, propylparaben, propylene glycol, simethicone emulsion, sorbic acid, noncrystallizing sorbitol solution, titanium dioxide and white petrolatum. Image Image

Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)- 10H -thieno[2,3- b ] [1,5]benzodiazepine. The molecular formula is C 17 H 20 N 4 S, which corresponds to a molecular weight of 312.44. The chemical structure is: Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, magnesium stearate, mannitol and microcrystalline cellulose. For olanzapine tablets, USP: Meets USP Dissolution Test 2. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, crospovidone, magnesium stearate, mannitol and microcrystalline cellulose. For olanzapine orally disintegrating tablets, USP: Meets USP Disintegration Test 2. str

Pazopanib is a kinase inhibitor. Pazopanib is presented as the hydrochloride salt, with the chemical name 5-[[4-[(2, 3-dimethyl-2H-indazol-6-yl)methylamino]-2-pyrimidinyl]amino]-2- methylbenzenesulfonamide monohydrochloride. It has the molecular formula C 21 H 23 N 7 O 2 S•HCl and a molecular weight of 473.99 g/mol. Pazopanib hydrochloride has the following chemical structure: Pazopanib hydrochloride is a white to off-white crystalline powder. It is very slightly soluble at pH 1 and practically insoluble above pH 4 in aqueous media. Pazopanib tablets are for oral use. Each 400-mg tablet of pazopanib contains 400 mg of pazopanib equivalent to 433.4 mg of pazopanib hydrochloride. The inactive ingredients of pazopanib tablets are: Tablet Core: magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Coating: White film-coat: hypromellose, polyethylene glycol 400, polysorbate 80, and titanium dioxide. Chemical Structure