ascend laboratories, llc - Medication Listings

Droxidopa capsules contain droxidopa, which is a synthetic amino acid precursor of norepinephrine, for oral administration. Chemically, droxidopa is (–)-threo-3-(3,4-Dihydroxyphenyl)-L-serine. It has the following structural formula: Droxidopa is an odorless, tasteless, white to light brown color powder. It is slightly soluble in water, and practically insoluble in methanol, glacial acetic acid, ethanol, acetone, ether, and chloroform. It is soluble in dilute hydrochloric acid. It has a molecular weight of 213.19 and a molecular formula of C 9 H 11 NO 5 . Droxidopa capsules also contain the following inactive ingredients: mannitol, pregelatinised starch (corn starch), and magnesium stearate. The capsule shell is printed with black ink. The black inks contain shellac, propylene glycol, black iron oxide, potassium hydroxide. The capsule shell contains the following inactive ingredients: 100 mg – gelatin, titanium dioxide, FD&C Blue No. 2, black and red iron oxide; 200 mg – gelatin, titanium dioxide, FD&C Blue No. 2, black and yellow iron oxide; 300 mg – gelatin, titanium dioxide, FD&C Blue No. 2, yellow iron oxide. Droxidopa capsules differ in size and color by strength [see Dosage Forms and Strengths ( 3 )] . droxi01

Enalapril maleate oral solution is the maleate salt of enalapril, the ethyl ester prodrug of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as (S)-1-[N-[1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl]-L-proline, (Z)-2-butenedioate salt (1:1). Its empirical formula is C 20 H 28 N 2 O 5 •C 4 H 4 O 4 , and its structural formula is: Enalapril maleate is a off-white, crystalline powder with a molecular weight of 492.52. It is practically insoluble in n-Heptane (nonpolar organic solvent), slightly soluble in acetone (semi polar organic solvent), sparingly soluble in water, soluble in alcohol, and freely soluble in methanol and dimethyl formamide. Enalapril maleate oral solution is a ready-to-use oral solution. Each 1 mL contains 1 mg of enalapril maleate, USP equivalent to 0.764 mg of enalapril. Inactive ingredients include citric acid, mixed berry flavor, purified water, sodium citrate, methylparaben, propyl paraben, xylitol and sucralose. It may also contain hydrochloric acid or sodium hydroxide for pH adjustment. Enalapril maleate oral solution is clear and colorless. enalapril-st

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 either 250 mg or 500 mg of 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)-B-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: Inactive Ingredients croscarmellose sodium, crospovidone, D&C red #30/helendon pink aluminum lake, hydroxypropyl cellulose, hypromellose phthalate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, silicon dioxide, sodium citrate dehydrate, sodium hydroxide pellets, sorbitan monooleate, talc and titanium dioxide. erythromycin-structure

The chemical name of eslicarbazepine acetate is (S)-10-Acetoxy-10,11-dihydro-5H­dibenz[b,f]azepine-5-carboxamide. Eslicarbazepine acetate 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 is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each eslicarbazepine acetate tablets contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: copovidone, croscarmellose sodium, microcrystalline cellulose, colloidal silicon dioxide and sodium stearyl fumarate.

The active ingredient in the proton pump inhibitor esomeprazole magnesium delayed-release capsules, USP for oral administration is bis (5-methoxy-2-[(S)-[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl]sulfinyl]-1 H -benzimidazole-1-yl) magnesium trihydrate. 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 34 H 36 MgN 6 O 6 S 2 • 3H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium 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 is supplied as Esomeprazole magnesium delayed-release capsules, USP. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated pellets with the following inactive ingredients: Colloidal silicon dioxide, hypromellose, magnesium stearate, meglumine, methacrylic acid and ethyl acrylate copolymer dispersion, mono & diglycerides, poloxamer, sugar spheres, talc and triethyl citrate. The capsule shells and Imprinting Ink have the following inactive ingredients: Capsule shell: gelatin, FD & C Blue 1, FD & C Red 40, titanium dioxide, sodium lauryl sulphate and Imprinting Ink: potassium hydroxide, shellac, and titanium dioxide. Meets USP Dissolution Test 2. esomeprazole-structure

Everolimus is a macrolide immunosuppressant. The chemical name of everolimus is (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)­ 4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36­ dioxa-4-aza-tricyclo[30.3.1.04,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C 53 H 83 NO 14 and the molecular weight is 958.25. The structural formula is: Everolimus is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone type A, hypromellose, lactose anhydrous, lactose monohydrate and magnesium stearate as inactive ingredients. evero-str

Ezetimibe, USP is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe, USP is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The empirical formula is C 24 H 21 F 2 NO 3 . Its molecular weight is 409.4 and its structural formula is: Ezetimibe, USP is a white to off white, crystalline powder that is soluble in methanol. Ezetimibe, USP has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe Tablet, USP is available as a tablet for oral administration containing 10 mg of ezetimibe, USP and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, Hypromellose, sodium lauryl sulfate, crospovidone, microcrystaline cellulose, and magnesium stearate. ezetimibe-structure

Ezetimibe and simvastatin tablets contains ezetimibe, USP, a dietary cholesterol absorption inhibitor, and simvastatin, USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe, USP is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C 24 H 21 F 2 NO 3 and its molecular weight is 409.43. Ezetimibe, USP is a white to off white, crystalline powder, hygroscopic that is soluble in methanol. Its structural formula is: Simvastatin, USP, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2, 2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H -pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S- [1α,3α,7β,8β(2 S* ,4 S* ),-8aβ]]. The molecular formula of simvastatin, USP is C 25 H 38 O 5 and its molecular weight is 418.57. Simvastatin, USP is a white to off-white powder that is freely soluble in chloroform, methanol and alcohol. Sparingly soluble in Propylene glycol, very slightly soluble in Hexane. Practically insoluble in water. Its structural formula is: Ezetimibe and simvastatin tablets is available for oral use as tablets containing 10 mg of ezetimibe, USP, and 10 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin tablets 10/80). Each tablet contains the following inactive ingredients: Lactose Monohydrate, Microcrystalline Cellulose, Croscarmellose Sodium, Sodium Lauryl Sulfate, Hypromellose, Citric Acid Monohydrate, Propyl Gallate, Butylated Hydroxy Anisole and Magnesium Stearate. ES-Str1.jpg ES-Str2.jpg

The active ingredient in famotidine for oral suspension, USP is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl] methyl] thio] propanimidamide. The empirical formula of famotidine is C 8 H 15 N 7 O 2 S 3 and its molecular weight is 337.43. Its structural formula is: Each 5 mL of famotidine for oral suspension, USP when prepared as directed contains 40 mg of famotidine and the following inactive ingredients: sucrose, starch corn, powdered cellulose, citric acid, sucralose, xanthan gum and flavors (cherry, banana and peppermint). Added as preservatives are sodium benzoate, sodium methylparaben and sodium propylparaben. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol. fam01

The active ingredient in famotidine tablets is a histamine-2 (H2) receptor antagonist. Famotidine is N' -(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C 8 H 15 N 7 O 2 S 3 and its molecular weight is 337.43. Its structural formula is: Each famotidine tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate (type-A), hypromellose, titanium dioxide, triacetin, talc and macrogol. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol. famotidine-str

The active ingredient in famotidine tablets is a histamine-2 (H2) receptor antagonist. Famotidine is N' -(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C 8 H 15 N 7 O 2 S 3 and its molecular weight is 337.43. Its structural formula is: Each famotidine tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate (type-A), hypromellose, titanium dioxide, triacetin, talc and macrogol. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol. famotidine-str

Febuxostat is a xanthine oxidase inhibitor. The active ingredient in febuxostat tablets is 2-[3-cyano-4-(2-methylpropoxy) phenyl]-4-methylthiazole-5-carboxylic acid, with a molecular weight of 316.38. The empirical formula is C 16 H 16 N 2 O 3 S. The chemical structure is: Febuxostat is a non-hygroscopic, white crystalline powder that is freely soluble in dimethylformamide; soluble in dimethylsulfoxide; sparingly soluble in ethanol; slightly soluble in methanol and acetonitrile; and practically insoluble in water. The melting range is 205ºC to 208ºC. Febuxostat tablets for oral use contain the active ingredient, febuxostat, and are available in two dosage strengths, 40 mg and 80 mg. Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. Febuxostat tablets are coated with Opadry II, green. febuxostat-structure

Fesoterodine fumarate extended-release tablets contains fesoterodine fumarate. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist. Chemically, fesoterodine fumarate is designated as isobutyric acid 2-((R)-3-diisopropylammonium-1­ phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate. The empirical formula is C 30 H 41 NO 7 and its molecular weight is 527.66. The structural formula is: The asterisk (*) indicates the chiral carbon. Fesoterodine fumarate is a white to off-white powder, which is freely soluble in water. Each fesoterodine fumarate extended-release tablets contains either 4 mg or 8mg of fesoterodine fumarate and the following inactive ingredients: glyceryl behenate, hypromellose, FD&C Blue #2/Indigo carmine aluminum lake, soya lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. fesoterodine-str

Finasteride, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α -reductase, an intracellular enzyme that converts the androgen testosterone into 5α -dihydrotestosterone (DHT). Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1, 1-dimethylethyl)-3-oxo-, (5α , 17ß)-. The empirical formula of finasteride is C 23 H 36 N 2 O 2 and its molecular weight is 372.55. Its structural formula is: Finasteride USP is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents, but is practically insoluble in water. Finasteride tablets, USP for oral administration are film-coated tablets that contain 5 mg of finasteride and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate, lauroylmacrogol 32 Glycer, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and FD & C blue #2/indigo carmine aluminium lake. Structutre

Finasteride tablets, USP contain finasteride as the active ingredient. Finasteride, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). The chemical name of finasteride is N-tert -Butyl-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide. The empirical formula of finasteride is C 23 H 36 N 2 O 2 and its molecular weight is 372.55. Its structural formula is: Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents but is practically insoluble in water. Finasteride Tablets, USP are film-coated tablets for oral administration. Each tablet contains 1 mg of finasteride and the following inactive ingredients: hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, lauroylmacrogol 32 glycerides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, and titanium dioxide. finasteride-structure.jpg

Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below: Fingolimod hydrochloride is a white to practically white powder that is freely soluble in water and alcohol and soluble in propylene glycol. It has a molecular weight of 343.93 g/mol. Fingolimod capsules are provided as 0.5 mg hard gelatin capsules for oral use. Each capsule contains 0.56 mg of fingolimod hydrochloride, equivalent to 0.5 mg of fingolimod. Each fingolimod capsule 0.5 mg is supplied as an imprinted hard-shell capsule containing the following inactive ingredients: dibasic calcium phosphate, magnesium stearate. The capsule shells contain gelatin, iron oxide yellow, and titanium dioxide. The imprinting ink contains propylene glycol, shellac and in addition, the black ink contains black iron oxide, and potassium hydroxide and yellow ink contains yellow iron oxide. fingolimod-hcl-structure.

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: orange flavor, saccharin and sucrose. The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as ( 1R,2S )-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white granular compound with a molecular weight of 259.2. Its empirical formula is C 3 H 7 O 4 P.C 4 H 11 NO 3 , and its chemical structure is as follows: fosfo_str

HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is: C 8 H 8 N 4 • HCl HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg HydrALAZINE hydrochloride, USP. Tablets also contain microcrystalline cellulose, sodium starch glycolate, stearic acid, povidone K-30, colloidal silicon dioxide, mannitol and FD&C Yellow No 6. structure

Ibuprofen and famotidine is supplied as a tablet for oral administration which combines the nonsteroidal anti- inflammatory drug, ibuprofen, and the histamine H 2 -receptor antagonist, famotidine. Ibuprofen is (±)-2-( p- isobutylphenyl)propionic acid. Its chemical formula is C 13 H 18 O 2 and molecular weight is 206.28. Ibuprofen is a white powder that is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. Its structural formula is: Famotidine is N'- (aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. Its chemical formula is C 8 H 15 N 7 O 2 S 3 and molecular weight is 337.45. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol. Its structural formula is: Each ibuprofen and famotidine tablet contains ibuprofen, USP (800 mg) and famotidine, USP (26.6 mg). The inactive ingredients in ibuprofen and famotidine tablet include: Ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1/brilliant blue FCF aluminum, FD&C blue #2/indigo carmine aluminum lake, ferrosoferric oxide, hypromellose, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, propylene glycol, shellac, talc and titanium Dioxide. ibuprofen-structure famotidine-structure

Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets contain Imatinib mesylate equivalent to 100 mg or 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl­1-piperazinyl) methy1]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl] amino]-phenyl] benzamide methanesulfonate and Its structural formula is Imatinib mesylate is a off white to pale yellow crystalline powder. Its molecular formula is C 29 H 31 N 7 O·CH 4 SO 3 and its molecular weight is 589.7. Imatinib mesylate is soluble in water, slightly soluble in methanol and Dimethyl sulphoxide. Inactive Ingredients: Povidone (USP) and Magnesium Stearate (NF). Tablet coating: Hypromellose (USP), yellow iron oxide (NF), poly ethylene glycol (NF), talc (USP), titanium dioxide (USP), and red iron oxide (NF). imatinib-struc

Itraconazole, 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: (±)-1-[(R*)-sec-butyl]-4-[p-[4-[p-[[(2R*,4S*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ 2 -1,2,4-triazolin-5-one mixture with (±)-1-[(R*)-sec-butyl]-4-[p-[4-[p-[[(2S*,4R*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ 2 -1,2,4-triazolin-5-one or (±)-1-[(RS)-sec-butyl]-4-[p-[4-[p-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-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 has a molecular formula of C 35 H 38 Cl 2 N 8 O 4 and a molecular weight of 705.64. It is a white or almost white powder. Freely soluble in methylene chloride, sparingly soluble in tetrahydrofuran, very slightly soluble in alcohol and practically insoluble in water. It has a pKa of 3.70 (based on extrapolation of values obtained from methanolic solutions) and a log (n-octanol/water) partition coefficient of 5.66 at pH 8.1. Itraconazole capsules contain 100 mg of itraconazole coated on sugar spheres (composed of sucrose, maize starch and purified water). Inactive ingredients are hard gelatin capsule, hypromellose, poloxamer 188, ethanol absolute, methylene chloride, polyethylene glycol 20000, talc, colloidal silicon dioxide, SLS, titanium dioxide, FD&C blue 1, FD&C red 40, FD&C red 3 and white ink (containing: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, titanium dioxide and potassium hydroxide). FDA approved dissolution test specifications differ from USP itraconazole-struct

The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3­-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13 H 18 N 2 O 3 and its molecular weight is 250.30. The chemical structure is: Lacosamide, USP is a white to light yellow powder. It is freely soluble in methanol, soluble in anhydrous ethanol, sparingly soluble in water, slightly soluble in acetonitrile, and practically insoluble in heptane. 11.1 Lacosamide Tablets, USP Lacosamide tablets, USP for oral administration contain lacosamide and the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and dye pigments as specified below: Lacosamide tablets,USP are supplied as debossed tablets and contain the following coloring agents: 50 mg tablets: red iron oxide, black iron oxide, FD&C Blue #2/indigo carmine aluminum lake 100 mg tablets: yellow iron oxide 150 mg tablets: yellow iron oxide, red iron oxide, black iron oxide 200 mg tablets: FD&C Blue #2/indigo carmine aluminum lake FDA approved dissolution test specifications differ from USP laco-str

The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3­-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13 H 18 N 2 O 3 and its molecular weight is 250.30. The chemical structure is: Lacosamide, USP is a white to light yellow powder. It is freely soluble in methanol, soluble in anhydrous ethanol, sparingly soluble in water, slightly soluble in acetonitrile, and practically insoluble in heptane. 11.3 Lacosamide Oral Solution, USP Lacosamide oral solution, USP contains 10 mg of lacosamide per mL. The inactive ingredients are acesulfame potassium, carboxymethylcellulose sodium, citric acid anhydrous, glycerin, methyl paraben, noncrystallizing sorbitol solution, polyethylene glycol, sodium chloride, strawberry flavor (propylene glycol, artificial flavors, acetic acid), masking flavor (propylene glycol, water, acetic acid, artificial flavors, ammoniated glycyrrhizin, aspartame acesulfame). laco-structure

Lamotrigine tablets (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 is a white to pale cream-colored powder and has a pK a of 5.7. Lamotrigine 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 (Light yellow), 100 mg (Light yellow), 150 mg (Light yellow), and 200 mg (Light blue) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: Lactose monohydrate; Magnesium stearate; Microcrystalline cellulose; Pregelatinized starch (corn); Sodium starch glycolate; Sodium lauryl sulphate; Ferric oxide, yellow; Dual FD&C Blue 01 Lk (200 mg tablet only).

The active ingredient in lansoprazole delayed-release capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C 16 H 14 F 3 N 3 O 2 S with a molecular weight of 369.37. Lansoprazole has the following structure: Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules for oral administration. Lansoprazole is available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric- coated pellets consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, D&C Red No. 28, FD&C Blue No.1, FD&C Red No. 40, gelatin, hypromellose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol 6000, polysorbate-80, sodium lauryl sulphate, sucrose, sugar spheres, talc and titanium dioxide. The printing ink contains potassium hydroxide, propylene glycol, shellac, strong ammonia, titanium dioxide. In addition to this, the 15 mg capsule also contains FD&C Green No.3. FDA approved dissolution test specifications differ from USP Lansoprazole-str

Lanthanum carbonate chewable tablet contains lanthanum carbonate with molecular formula La 2 (CO 3 ) 3 xH 2 O (where x=8 moles of water) and molecular weight 457.8 (anhydrous mass). Lanthanum carbonate octahydrate is insoluble in water and soluble in acids. The molecular weight of lanthanum carbonate octahydrate is 601.95 g/mol. Each white to off-white, round flat with a beveled edge chewable tablet contains lanthanum carbonate hydrate equivalent to 500, 750, or 1,000 mg of elemental lanthanum and the following inactive ingredients: maltitol, crospovidone and sodium stearyl fumarate. The chemical structure of lanthanum carbonate octahydrate is: lanthanum-struc

Levetiracetam,USP is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 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 almost white powder. It is very soluble in water, soluble in acetonitrile, practically insoluble in hexane. Levetiracetam tablets, USP contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, magnesium stearate, maize starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, talc, titanium dioxide and additional agents listed below: 250 mg tablets: FD&C blue #2 indigo carmine aluminum lake 500 mg tablets: iron oxide yellow 750 mg tablets: iron oxide yellow, iron oxide red Meets USP Dissolution Test 3 leve-stru

Linezolid Tablets contain linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-({3-[3-fluoro-4-(morpholin-4-yl)phenyl]-2-oxo-1,3-oxazolidin-5-yl}methyl)acetamide. The empirical formula is C 16 H 20 FN 3 O 4 . Its molecular weight is 337.35, and its chemical structure is represented below: Linezolid Tablet for oral administration contains 600 mg linezolid as a film-coated compressed tablet. Inactive ingredients are pregelatinized starch, mannitol, colloidal silicon dioxide, copovidone, sodium stearyl fumarate, hypromellose, polyethylene glycol and titanium dioxide. The sodium (Na + ) content is 1.06 mg per 600 mg tablet (0.05 mEq/tablet). Linezolid-Image

Lurasidone hydrochloride tablets are 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)-1-piperazinyl] methyl] cyclohexyl methyl}hexahydro-4, 7-methano-1H-isoindole-1, 3 (2H)-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, lactose monohydrate, pregelatinized starch, croscarmellose sodium, povidone, anhydrous citric acid, magnesium stearate, hypromellose, titanium dioxide and Polyethylene glycol. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&C Blue No. 1 Aluminum Lake. lurasidone-structure

Each mesalamine extended-release capsule is a delayed-and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is: Molecular Weight: 153.14 Molecular Formula: C 7 H 7 NO 3 Each mesalamine extended-release capsules, USP contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of mesalamine extended-release capsules USP are black iron oxide, colloidal silicon dioxide, edible black ink which contains shellac, ethyl acrylate and methyl methacrylate copolymer, FD and C Blue # 1, FD and C Red # 3, gelatin, hypromellose, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, microcrystalline cellulose, polyethylene glycol, potassium hydroxide, propylene glycol, sodium lauryl sulphate, talc, titanium dioxide, triethyl citrate, vanillin. FDA approved dissolution test specifications differ from USP acceptance criteria mesalamine-structure

Metformin Hydrochloride Tablets USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown: Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4 H 11 N 5 • HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients povidone (K-30), povidone (K-90), pregelatinized starch,and magnesium stearate. In addition, the coating for the tablets contains artificial blackberry flavor, hypromellose and polyethylene glycol. Metformin Hydrochloride Structure

Methylphenidate hydrochloride oral solution contains methylphenidate hydrochloride a CNS stimulant. It is available as an oral solution in 5 mg/5 mL and 10 mg/5 mL strengths for oral administration. Chemically, methylphenidate hydrochloride is ( d, l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride and its structural formula is: Methylphenidate Hydrochloride C 14 H 19 NO 2 • HCl MW = 269.77 Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Each mL of methylphenidate hydrochloride oral solution 5 mg/5 mL contains 1 mg of methylphenidate hydrochloride USP. Each mL of methylphenidate hydrochloride oral solution 10 mg/5 mL contains 2 mg of methylphenidate hydrochloride USP. Methylphenidate hydrochloride oral solution also contains the following inactive ingredients: glycerin, polyethylene glycol 1450, hydrochloric acid, grape 501417C and purified water. methylphenidate-st

Methylphenidate hydrochloride tablets USP contains methylphenidate hydrochloride, a CNS stimulant. It is available as tablets of 5mg, 10mg, and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride tablets USP contains the following inactive ingredients: Colloidal Silicon Dioxide, D&C Yellow #10 Aluminium lake, FD&C Blue #1/Brilliant Blue FCF Aluminium lake (10-mg tablets), Lactose Monohydrate, Magnesium Stearate, Polyethylene glycol, Pregelatinized starch (5-mg and 20-mg tablets), Sucrose. Methylphenidate-structure

Metoprolol succinate, is a beta 1 -selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg, 47.5 mg, 95 mg and 190 mg of metoprolol succinate equivalent to 25 mg, 50 mg, 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is: Metoprolol succinate, USP is a white or almost white, crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in Isopropyl alcohol; practically insoluble in ethyl-acetate. Inactive ingredients: Microcrystalline cellulose, Colloidal silicon dioxide, Povidone, Ethyl cellulose, Hypromellose, Methacrylic acid and ethyl acrylate copolymer dispersion, Triethyl citrate, Talc, Silicified Microcrystalline Cellulose, Polyethylene Glycol, Croscarmellose sodium, Sodium Stearyl Fumarate, Titanium dioxide. "FDA approved dissolution testing specifications differ from USP" metoprolol-structure

Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4 S -(4α,4aα,5aα, 12aα)]-4,7–Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below: C 23 H 27 N 3 O 7 •HCl M. W. 493.95 Minocycline hydrochloride extended-release tablets, USP for oral administration contain minocycline hydrochloride USP equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg of minocycline. In addition, 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg tablets contain the following inactive ingredients: lactose monohydrate, hypromellose type 2910, hypromellose type 2208, colloidal silicon dioxide, magnesium stearate, titanium dioxide and triacetin. The 45 mg tablets also contain iron oxide black. The 65 mg tablets also contain FD&C blue #1/brilliant blue FCF aluminium lake, polyethylene glycol 3350, FD&C blue #2/indigo carmine aluminum lake and D&C yellow #10 aluminum lake. The 55 mg tablets also contain macrogol, FD&C RED #40. The 80 mg tablets also contain macrogol, FD&C blue #2, FD&C red #40, FD&C yellow #6. The 90 mg tablets also contain iron oxide yellow and polyethylene glycol 3350. The 105 mg tablets also D&C red #27, macrogol, FD&C blue #1. The 115 mg tablets also contain D&C yellow #10 aluminum lake, FD&C blue #1/brilliant blue FCF aluminium lake and FD&C blue #2/indigo carmine aluminum lake. The 135 mg tablets also contain polyethylene glycol 3350 and iron oxide red. The USP Dissolution Test is pending. mino-struc

Morphine sulfate tablets are an opioid agonist, available in 15 mg and 30 mg for oral administration: 15 mg tablet: Each tablet contains 15 mg morphine sulfate, USP (equivalent to 11.25 mg morphine). 30 mg tablet: Each tablet contains 30 mg morphine sulfate, USP (equivalent to 22.5 mg morphine). Chemically, morphine sulfate is 7,8-didehydro-4,5α-epoxy-17-methylmorphinan-3,6α-diol sulfate (2:1) (salt) pentahydrate. Morphine sulfate, USP is a white to off-white crystalline solid. It is soluble in water and slightly soluble in alcohol, but is practically insoluble in chloroform. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pka is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). Its molecular formula is (C 17 H 19 NO 3 ) 2 • H 2 SO 4 • 5H 2 O, and it has the following chemical structure: Each tablet contains 15 or 30 mg of morphine sulfate, USP and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinised starch. Structure

Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6 (1,3dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C 23 H 31 NO 7 , a molecular weight of 433.50, and the following structural formula: Mycophenolate mofetil is a white to off-white crystalline powder. It is slightly soluble in water (43 mcg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil USP for oral suspension is available for oral administration as a powder for oral suspension, which when constituted contains 200 mg/mL of mycophenolate mofetil Inactive ingredients in mycophenolate mofetil for oral solution 200 mg include Sorbitol, sodium citrate dihydrate, citric acid anhydrous, methylparaben, xanthan gum, aspartame, soybean lecithin and N &A gum fruit flavor. FDA approved dissolution test specifications differ from USP. mycophenolate-structure-.jpg

Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has an empirical formula of C 23 H 31 NO 7 , a molecular weight of 433.50, and the following structural formula: Mycophenolate mofetil is a white to off-white crystalline powder. It is slightly soluble in water (43 mcg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of mycophenolate mofetil. Inactive ingredients in Mycophenolate mofetil capsules USP 250 mg include croscarmellose sodium, pregelatinized starch, povidone (K-90), isopropyl alcohol and magnesium stearate. The capsule shells contain gelatin, sodium lauryl sulphate, FD&C blue 2, red iron oxide, yellow iron oxide and titanium dioxide. The capsule is printed with edible black ink comprised of black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, strong ammonia solution. Inactive ingredients in mycophenolate mofetil tablets USP 500 mg include croscarmellose sodium, povidone (K-90), isopropyl alcohol, microcrystalline cellulose, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, red iron oxide, black iron oxide, and yellow iron oxide. FDA approved dissolution test specifications differ from USP. Structure

Mycophenolic acid delayed-release tablets, USP are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid sodium salt. Its empirical formula is C 17 H 19 O 6 Na. The molecular weight is 342.32 g/mol and the structural formula is: Mycophenolic acid, as the sodium salt, is a white to off-white, crystalline powder and is highly soluble in aqueous media at physiological pH and practically insoluble in 0.1N hydrochloric acid. Mycophenolic acid, is available for oral use as delayed-release tablets containing either 180 mg or 360 mg of mycophenolic acid as the sodium salt. Inactive ingredients include anhydrous lactose, colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate and povidone (K-30). The enteric coating of the tablet consists of colloidal silicon dioxide, FD&C Blue #2/Indigo carmine Aluminium lake (180 mg), hypromellose phthalate (HP-50), iron oxide red (360 mg), iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, triethyl citrate, imprinted with edible ink consist of iron oxide black, propylene glycol, shellac. myco-str

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 off white crystalline powder that is sparingly soluble in dimethylformamide, slightly soluble in methanol, very slightly soluble in water and practically insoluble in 0.1 M hydrochloric acid. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 (for 10 mg strength), FD&C Blue #2 (for 2.5 mg, 10 mg and 20 mg strengths), FD&C Yellow #6 (for 5 mg strength), polyethylene glycol 6000, hypromellose 15cps, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and maize starch. neb-structure

Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester, C 17 H 18 N 2 O 6 , and has the structural formula: Nifedipine is a yellow powder, freely soluble in acetone; practically insoluble in water. It has a molecular weight of 346.3. Nifedipine extended-release tablet is formulated as a once-a-day controlled-release tablet for oral administration to provide 30, 60, or 90 mg of nifedipine. Each tablet contains 33 mg nifedipine to provide a 30 mg dose. Each tablet contains 66 mg nifedipine to provide a 60 mg dose. Each tablet contains 99 mg nifedipine to provide a 90 mg dose. Inert ingredients in the formulations are: ammonium hydroxide; black iron oxide; cellulose acetate; hydroxypropyl cellulose; propylene glycol; hypromellose; magnesium stearate; polyethylene glycol; polyethylene oxide; butylated hydroxytoluene; red ferric oxide; shellac; sodium chloride; titanium dioxide. FDA approved dissolution test specifications differ from USP. System Components and Performance Nifedipine extended-release tablet is similar in appearance to a conventional tablet. It consists, however, of a semipermeable membrane surrounding an osmotically active drug core. The core itself is divided into two layers: an “active” layer containing the drug, and a “push” layer containing pharmacologically inert (but osmotically active) components. As water from the gastrointestinal tract enters the tablet, pressure increases in the osmotic layer and “pushes” against the drug layer, releasing drug through the precision laser-drilled tablet orifice in the active layer. Nifedipine extended-release tablets are designed to provide nifedipine at an approximately constant rate over 24 hours. This controlled rate of drug delivery into the gastrointestinal lumen is independent of pH or gastrointestinal motility. Nifedipine extended-release tablets depends for its action on the existence of an osmotic gradient between the contents of the bi-layer core and fluid in the gastrointestinal tract. Drug delivery is essentially constant as long as the osmotic gradient remains constant, and then gradually falls to zero. Upon swallowing, the biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as an insoluble shell. nif-str

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, USP 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 lactose monohydrate, hydroxypropyl cellulose, mannitol, and magnesium stearate. The color coating contains pectin, triacetin, titanium dioxide, talc, and FD&C Blue No. 2 Aluminum Lake (15 mg strength) or Iron Oxide Red (20 mg strength). Olanzapine tablets, USP of all strengths are imprinted with edible ink which contains shellac, Iron Oxide Black, N-Butyl Alcohol, Propylene Glycol, Ammonium Hydroxide. FDA approved dissolution test specifications differ from USP. olanzapine-structure

Olmesartan medoxomil,USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4-(1 hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29 H 30 N 6 O 6 and its structural formula is: Olmesartan medoxomil, USP is a white to off-white crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and in heptanes,slightly soluble in ethanol (96%),sparingly soluble in methanol. Olmesartan medoxomil tablets, USP is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil,USP and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, hydroxy propyl cellulose ,stearic acid,magnesium stearate, talc, titanium dioxide, and (5 mg only) yellow iron oxide. If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 6. Structure

Olmesartan medoxomil and hydrochlorothiazide tablet is a combination of an angiotensin II receptor antagonist (AT 1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p (o- 1H -tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29 H 30 N 6 O 6 and its structural formula is: Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiadiazine-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 is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Olmesartan medoxomil and hydrochlorothiazide tablet is available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: hydroxypropylcellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, red iron oxide, talc, titanium dioxide and yellow iron oxide, stearic acid, polyethylene glycol. olmesartan-str-1 hctz-str-2

Oxcarbazepine oral suspension, USP is an antiepileptic drug available as a 300 mg/5 mL (60 mg/mL) oral suspension. Oxcarbazepine is 10,11-Dihydro-10-oxo- 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is: Oxcarbazepine, USP is light orange to creamish white or off-white powder. It is slightly soluble in chloroform, dichloromethane, acetone and methanol and practically insoluble in ethanol, ether and water. Its molecular weight is 252.27. Oxcarbazepine oral suspension, USP contains the following inactive ingredients: methyl paraben, propyl paraben, saccharin sodium dihydrate, polyoxyl stearate, malic acid, non-crystalline sorbitol, propylene glycol, microcrystalline cellulose, carboxy methyl cellulose sodium, hydroxyethyl cellulose, cherry flavour and purified water. FDA approved dissolution test specifications differ from USP. oxcarbazepine-12

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 pregelatinized starch, and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg) contain red iron oxide, yellow iron oxide. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac. Pregabalin 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 powder with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water . The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless transparent solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure.The oral solution contains 20 mg/mL of pregabalin, along with cherry flavour,disodium hydrogen phosphate anhydrous, methylparaben, monobasic sodium phosphate anhydrous, propylparaben, purified water and sucralose micronized as inactive ingredients. pregabalin-structure

Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [ b,f ] [1,4]thiazepin-11-yl-1-piperazinyl) ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42 H 50 N 6 O 4 S 2 •C 4 H 4 O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is: Quetiapine fumarate USP is a white to off-white crystalline powder which is moderately soluble in water. Quetiapine tablets, USP is supplied for oral administration as 25 mg (round peach), 50 mg (round, white), 100 mg (round yellow), 150 mg (round, off white to light yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets. Inactive ingredients are povidone, dibasic dicalcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide. The 25 mg tablets contain red iron oxide and yellow iron oxide and the 100 mg, 150 mg and 400 mg tablets contain only yellow iron oxide. Each 25 mg tablet contains 28.78 mg of quetiapine fumarate USP equivalent to 25 mg quetiapine. Each 50 mg tablet contains 57.56 mg of quetiapine fumarate USP equivalent to 50 mg quetiapine. Each 100 mg tablet contains 115.13 mg of quetiapine fumarate USP equivalent to 100 mg quetiapine. Each 150 mg tablet contains 172.70 mg of quetiapine fumarate USP equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230.27 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345.40 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. Each 400 mg tablet contains 460.54 mg of quetiapine fumarate USP equivalent to 400 mg quetiapine. Structure

The active ingredient in rabeprazole sodium delayed-release tablets is rabeprazole sodium, which is a proton pump inhibitor. It is a substituted benzimidazole known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfinyl]-1 H– benzimidazole sodium salt. It has an empirical formula of C 18 H 20 N 3 NaO 3 S and a molecular weight of 381.42. Rabeprazole sodium is a white to slightly yellowish-white solid. It is very soluble in water and methanol, freely soluble in ethanol, chloroform, and ethyl acetate and insoluble in ether and n-hexane. The stability of rabeprazole sodium is a function of pH; it is rapidly degraded in acid media, and is more stable under alkaline conditions. The structural figure is: Rabeprazole sodium delayed-release tablets is available for oral administration as Delayed-Release, enteric-coated tablets containing 20 mg of rabeprazole sodium. Inactive ingredients of the 20 mg tablet are Mannitol, Crospovidone, Magnesium Oxide Light, Hydroxy Propyl Cellulose, Sodium Stearyl Fumarate, Magnesium Stearate, Ethyl Cellulose, Hypromellose phthalate, Carnauba Wax, Diacetylated Monoglyceride. The coating material contains Polyvinyl Alcohol, Talc, Titanium Dioxide, Macrogol, Lecithin and Iron Oxide Yellow. The printing ink contains Shellac, Ferrosoferric Oxide, Propylene Glycol and Ammonium Hydroxide 28%. Rabe-Str

Ranolazine is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N ­ (2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has an empirical formula of C 24 H 33 N 3 O 4 , a molecular weight of 427.54 g/mole, and the following structural formula: Ranolazine is a white to off-white solid. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, ethanol, acetonitrile, and acetone; slightly soluble in ethyl acetate, isopropanol, toluene, and ethyl ether; and very slightly soluble in water. Ranolazine extended-release tablets contain 500 mg or 1000 mg of ranolazine and the following inactive ingredients: colloidal silicon dioxide, hypromellose, iron oxide yellow, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium hydroxide, talc, titanium dioxide and additional inactive ingredients for the 500 mg tablet include iron oxide red. ranolazine-structure