alembic pharmaceuticals limited - Medication Listings

Oseltamivir phosphate capsules, USP, an influenza neuraminidase inhibitor (NAI), are available as capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate, USP. In addition to the active ingredient, each capsule contains pregelatinized starch, croscarmellose sodium, povidone K-30, talc and sodium stearyl fumarate. The 30 mg and 75 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide. The 45 mg capsule shell contains gelatin, ferrosoferric oxide and titanium dioxide. Each capsule is printed with blue ink, which contains shellac and FD&C Blue No. 2 Aluminium Lake as the colorant. Oseltamivir phosphate is a white to off white powder with the chemical name (3R,4R,5S)-4-acetylamino-5-amino-3(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester, phosphate (1:1). The chemical formula is C 16 H 28 N 2 O 4 (free base). The molecular weight is 312.4 for oseltamivir free base and 410.4 for oseltamivir phosphate salt. The structural formula is as follows: Structure

Paclitaxel Injection, USP is a clear, colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel Injection, USP is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, USP, 527 mg of polyoxyl 35 castor oil, NF and 49.7% (v/v) dehydrated alcohol, USP and 2 mg citric acid, USP. Paclitaxel is a natural product with antitumor activity. Paclitaxel is obtained via a semi-synthetic process from Taxus baccata . The chemical name for paclitaxel is 5β,20-Epoxy-1,2α,4,7β, 10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine. Paclitaxel has the following structural formula: Paclitaxel, USP is a white to off-white crystalline powder with the empirical formula C 47 H 51 NO 14 and a molecular weight of 853.9. It is highly lipophilic, insoluble in water, and melts at around 216° to 217°C. paclitaxel-str

Paliperidone extended-release tablet contains paliperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone extended-release tablets contain a racemic mixture of (+)- and (-)- Paliperidone, USP. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H- pyrido [l,2-a]pyrimidin-4-one. Its molecular formula is C 23 H 27 FN 4 O 3 and its molecular weight is 426.49. The structural formula is: Paliperidone, USP is sparingly soluble in 0.1 N hydrochloride and in methylene chloride, slightly soluble in N,N dimethyl formamide and in tetrahydrofuran; practically insoluble in water, in 0.1 N sodium hydroxide, and in hexane. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. Paliperidone Extended-Release Tablets are formulated as a polymer matrix based once-a-day controlled release tablet for oral use. Inactive ingredients are mannitol, microcrystalline cellulose, hypromellose, magnesium stearate, hydroxypropyl cellulose, hypromellose phthalate, ethylcellulose, dibutyl sebacate, polyethylene glycol and titanium dioxide. The 1.5 mg tablets also contain FD&C Yellow #6 Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #2 Aluminum Lake. The 6 mg tablets also contain iron oxide yellow, iron oxide red and iron oxide black. The 9 mg tablets also contain iron oxide red. The tablets are imprinted with edible black ink. The edible ink contains shellac, isopropyl alcohol, iron oxide black, n-butyl alcohol, propylene glycol and ammonium hydroxide. Delivery System Components and Performance Paliperidone Extended-Release Tablet uses a pH-independent hydrophilic matrix and pH dependent enteric coating to deliver Paliperidone, USP at a controlled rate. The Paliperidone Extended-Release Tablet comprises of an inner core made of the drug, rate controlling pH independent hydrophilic polymers and other excipients. The core is surrounded by barrier layer of pH independent polymer followed by enteric coating. When tablet expose to an acidic environment such as the stomach, the drug release will be minimal due to outer enteric coating of the pH dependent polymer. The outer enteric coating upon reaching an environment of pH 5.5 and above it starts to dissolve and the polymer in the inner core tablet will hydrate to form a gel layer. The drug releases via diffusion from a gel layer and subsequently through gel erosion. structure

Phytonadione is a vitamin K replacement, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.70. Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is C 31 H 46 O 2 and its molecular structure is: Phytonadione Injectable Emulsion, USP injection is a yellow, sterile, aqueous colloidal solution of vitamin K, with a pH of 4 to 6.5, available for injection by the intravenous, intramuscular, and subcutaneous routes. Phytonadione Injectable Emulsion, USP is available in 1 mg (1 mg/0.5 mL) single-dose prefilled syringes. Each 0.5 mL of Phytonadione Injectable Emulsion, USP contains the following inactive ingredients: 10 mg polysorbate 80, 10.4 mg propylene glycol, 0.17 mg sodium acetate anhydrous, and 0.00002 mL glacial acetic acid. Additional glacial acetic acid or sodium acetate anhydrous may have been added to adjust pH to meet USP limits of 4 to 6.5. phytonadione-structure

Pirfenidone belongs to the chemical class of pyridone. Pirfenidone tablets are available as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone. Pirfenidone has a molecular formula of C 12 H 11 NO and a molecular weight of 185.22. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white or pale yellow crystalline, non-hygroscopic powder. It is sparingly soluble in water, freely soluble in ethanol (96 percent), slightly soluble in heptane. The melting point is approximately 109°C. Pirfenidone tablets contain pirfenidone and the following inactive ingredients: microcrystalline cellulose, povidone,croscarmellose sodium,colloidal silicon dioxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow ( 267 mg ) and ferrosoferric oxide ( 801 mg ), iron oxide red ( 801 mg ). pirfenidone

Pramipexole dihydrochloride tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride is ( S )-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C 10 H 17 N 3 S · 2HCl · H 2 O, and its molecular weight is 302.26. The structural formula is: Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate USP. Inactive ingredients consist of betacyclodextrin (betadex), corn starch, colloidal silicon dioxide, povidone, magnesium stearate and microcrystalline cellulose. Structure

Pramipexole dihydrochloride extended-release tablets contain pramipexole, a non-ergot dopamine agonist. The chemical name of pramipexole dihydrochloride is ( S )-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C 10 H 17 N 3 S · 2HCl · H 2 O, and its molecular weight is 302.26. The structural formula is: Pramipexole dihydrochloride monohydrate USP is a white to almost white crystalline powder. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride monohydrate USP is freely soluble in water, soluble in methanol, slightly soluble in alcohol, practically insoluble in methylene chloride. Pramipexole dihydrochloride extended-release tablets, for oral administration, contain 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg or 4.5 mg of pramipexole dihydrochloride monohydrate USP. Inactive ingredients are betadex, microcrystalline cellulose, ethylcellulose, hydroxypropyl methyl cellulose, colloidal silicon dioxide, and magnesium stearate. Structure

Pramipexole dihydrochloride tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride is ( S )-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C 10 H 17 N 3 S · 2HCl · H 2 O, and its molecular weight is 302.26. The structural formula is: Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate USP. Inactive ingredients consist of betacyclodextrin (betadex), corn starch, colloidal silicon dioxide, povidone, magnesium stearate and microcrystalline cellulose. Structure

Prazosin hydrochloride, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy- 2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is: Molecular formula C 19 H 21 N 5 O 4• HCl It is a white to tan powder, slightly soluble in methanol, in dimethyl formamide, in dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in chloroform and in acetone. It has a molecular weight of 419.87. Each capsule for oral administration contains prazosin hydrochloride, USP equivalent to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: sucrose, corn starch, sodium lauryl sulfate, microcrystalline cellulose, colloidal silicon dioxide and magnesium stearate. The empty hard gelatin capsule shell contains gelatin and titanium dioxide. In addition, the 2 mg and 5 mg empty hard gelatin capsule shell also contain FD&C Blue 1 and FD&C Red 3. The empty hard gelatin capsule shells are imprinted with edible black ink containing shellac, potassium hydroxide and black iron oxide. FDA approved dissolution test specifications differ from USP. structure

Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8 H 17 NO 2 and the molecular weight is 159.23. The chemical structure of pregabalin is: Pregabalin, USP is a white to off-white, crystalline solid with a pK a1 of 4.2 and a pK a2 of 10.6. It is sparingly soluble in water. 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, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, USP, along with corn starch and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide which is used in 50 mg, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg strength of pregabalin capsules. The imprinting ink contains shellac, propylene glycol, black iron oxide, and potassium hydroxide. structure

Quetiapine fumarate is a psychotropic agent 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 is a white to cream colored powder which is practically insoluble in water. Quetiapine fumarate tablets are supplied for oral administration as 25 mg (round, white to off-white), 50 mg (round, white to off-white), 100 mg (round, white to off-white), 200 mg (round, white to off-white), 300 mg (capsule-shaped, white to off-white), and 400 mg (capsule-shaped, white to off-white) tablets. Inactive ingredients are povidone, dibasic calcium phosphate anhydrous, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, hydroxypropyl cellulose and titanium dioxide. Structure

Rivaroxaban, USP, a factor Xa (FXa) inhibitor, is the active ingredient in rivaroxaban tablets, USP with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5­-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban, USP is C 19 H 18 ClN 3 O 5 S and the molecular weight is 435.88. The structural formula is: Rivaroxaban, USP is a pure ( S )-enantiomer. It is an white to yellowish powder. Rivaroxaban, USP is soluble in dimethyl sulfoxide, practically insoluble to very slightly soluble in acetone and water. Each rivaroxaban tablet, USP contains 2.5 mg, 10 mg, 15 mg or 20 mg of rivaroxaban, USP. The inactive ingredients of rivaroxaban tablets, USP are: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for rivaroxaban 2.5 mg tablet is Opadry ® Yellow containing D&C yellow #10 aluminium lake, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol 6000, titanium dioxide, and for rivaroxaban 10 mg tablet is Opadry ® Pink containing hypromellose, iron oxide red, polyethylene glycol 6000, talc, titanium dioxide, and for rivaroxaban 15 mg tablet and 20 mg tablet is Opadry ® Brown containing hypromellose, iron oxide black, iron oxide red, polyethylene glycol 8000, and titanium dioxide. FDA approved dissolution test specifications differ from USP. rivaroxaban-str

Rivastigmine tartrate is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C 14 H 22 N 2 O 2 • C 4 H 6 O 6 (hydrogen tartrate salt – hta salt) and a molecular weight of 400.43 (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3.0. Rivastigmine Tartrate Capsules USP contain rivastigmine tartrate, equivalent to 1.5 mg, 3 mg, 4.5 mg and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides. Structure

Ropinirole is an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino) ethyl]-1,3-dihydro-2H-indol-2-one monohydrochloride and has an empirical formula of C16H24N2O•HCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is: Ropinirole Hydrochloride, USP is a white to yellow solid with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water. Each circular, biconvex, film-coated tablet contains ropinirole hydrochloride USP equivalent to ropinirole free base, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6 aluminum lake, hypromellose, iron oxides (iron oxide yellow, iron oxide red and iron oxide black), polyethylene glycol, polysorbate 80 and titanium dioxide. Structure

Ropinirole extended-release tablets contains ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C 16 H 24 N 2 O•HCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is: Ropinirole hydrochloride is a white to yellow solid with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water. Each capsule shaped, film coated tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethylcellulose sodium, colloidal silicon dioxide, hydrogenated castor oil, hypromellose, magnesium stearate, povidone, pregelatinized starch, ethylcellulose and one or more of the following: FD&C Blue No. 2 aluminum lake, ferric oxides (black, red, yellow), polyethylene glycol 6000, polyethylene glycol 8000, titanium dioxide, talc. Structure

Sacubitril and valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. The active pharmaceutical ingredient used to manufacture sacubitril and valsartan tablets contains a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5.The complexis chemically described as Octadecasodiumhexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)hexakis(N-pentanoyl-N-{[2´-(1H-tetrazol-1-id-5-yl)[1,1´-biphenyl]-4-yl]methyl}-L-valinate)-water (1/15). Its molecular formula (hemipentahydrate) is C 48 H 55 N 6 O 8 Na 3 2.5 H 2 O. Its molecular mass is 957.99 g/mol and its schematic structural formula is: Sacubitril and valsartan is available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The inactive ingredients are hypromellose, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, talc and magnesium stearate. The film-coat inactive ingredients are hypromellose, titanium dioxide, polyethylene glycol 4000, talc and iron oxide red. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow. Structure

Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2 R )-2-({2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1 H -indole-7-carboxamide and the molecular formula is C 25 H 32 F 3 N 3 O 4 with a molecular weight of 495.53. The structural formula of silodosin is: Silodosin is a white to pale yellow powder that melts at approximately 105 to 109°C. It is freely soluble in acetic acid, freely soluble in alcohol and very slightly to practically soluble in water. Each silodosin capsules 4 mg capsule for oral administration contains 4 mg silodosin, and the following inactive ingredients: pregelatinized starch, sucrose, sodium lauryl sulfate and magnesium stearate. The size #3 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible gold ink containing shellac, propylene glycol and iron oxide yellow. Each silodosin capsules 8 mg capsule for oral administration contains 8 mg silodosin, and the following inactive ingredients: pregelatinized starch, sucrose, sodium lauryl sulfate and magnesium stearate. The size #1 hard gelatin capsules contain gelatin and titanium dioxide. The capsules are printed with edible green ink containing shellac, propylene glycol, iron oxide yellow FD&C Blue No. 1 Aluminum Lake. Structure

Solifenacin succinate tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1 S )-(3 R )-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1 H )-iso-quinolinecarboxylate (1:1) having an empirical formula of C 23 H 26 N 2 O 2 •C 4 H 6 O 4 , and a molecular weight of 480.55. The structural formula of solifenacin succinate is: Solifenacin succinate is a white to off white powder. It is freely soluble in water, methanol, acetic acid and dimethyl sulfoxide. Each solifenacin succinate tablet contains 5 mg or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inert ingredients: lactose monohydrate, hypromellose, corn starch, magnesium stearate,titanium dioxide, polyethylene glycol, talc, iron oxide yellow with D&C Yellow #10 Aluminum Lake (5 mg solifenacin succinate tablet) or iron oxide red (10 mg solifenacin succinate tablet). Structure

Sumatriptan injection USP contains sumatriptan succinate, a selective 5-HT 1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethyl amino) ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure: The molecular formula is C 14 H 21 N 3 O 2 S•C 4 H 6 O 4 , representing a molecular weight of 413.5. Sumatriptan succinate is a white or almost white powder that is readily soluble in water and in saline. Sumatriptan injection USP is a clear, colorless to pale yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 0.5 mL of sumatriptan injection, 8 mg/mL contains 5.6 mg of sumatriptan succinate equivalent to 4 mg of sumatriptan and 3.8 mg of sodium chloride, USP in Water for Injection, USP. Each 0.5 mL of sumatriptan injection, 12 mg/mL contains 8.4 mg of sumatriptan succinate equivalent to 6 mg of sumatriptan and 3.5 mg of sodium chloride, USP in Water for Injection, USP. The pH range of both solutions is approximately 4.2 to 5.3. The osmolality of both injections is 291 mOsmol. sumatriptan-structure

Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22 H 19 N 3 O 4 representing a molecular weight of 389.41. The structural formula is: The chemical designation is pyrazino[1’,2’:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a white to off white powder that is slightly soluble in dichloromethane and very slightly soluble in methanol. Tadalafil tablets USP are available as round shaped tablets (2.5 mg, 5 mg and 10 mg) and oval shaped tablets (20 mg) for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil and the following inactive ingredients: hydroxy propyl cellulose, lactose monohydrate, croscarmellose sodium, sodium lauryl sulphate, povidone k-25, colloidal silicone dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol 6000, talc and iron oxide yellow. Structure

Tavaborole topical solution, 5% contains tavaborole, 5% (w/w) in a clear, colorless alcohol-based solution for topical use. The active ingredient, tavaborole, is an oxaborole antifungal with the chemical name of 5-fluoro-1,3-dihydro-1-hydroxy-2,1-benzoxaborole. The chemical formula is C 7 H 6 BFO 2 , the molecular weight is 151.93 and the structural formula is: Tavaborole is a white to off-white powder. It is slightly soluble in water and freely soluble in ethanol and propylene glycol. Each mL of tavaborole topical solution contains 43.5 mg of tavaborole. Inactive ingredients include alcohol (73.11% v/v), edetate calcium disodium, and propylene glycol. Image

Telmisartanis a non-peptide angiotensin II receptor (type AT 1 ) antagonist. Telmisartan is chemically described as 4’-[(1,4’-dimethyl-2’-propyl [2,6’-bi-1H-benzimidazol]-1’-yl)methyl]-[1,1’-biphenyl]-2-carboxylic acid. Its empirical formula is C 33 H 30 N 4 O 2 , its molecular weight is 514.63, and its structural formula is: Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Telmisartan tablets, USP are available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan. The tablets contain the following inactive ingredients: mannitol, sodium hydroxide, meglumine, povidone, sodium stearyl fumarate and magnesium stearate. Telmisartan tablets are hygroscopic and require protection from moisture. The USP Dissolution Test is pending. Structure

Telmisartan and amlodipine tablets are a fixed dose combination of telmisartan and amlodipine. Telmisartan and amlodipine tablets contain telmisartan, a non-peptide angiotensin II receptor (type AT 1 ) antagonist. Telmisartan is a white to slightly yellow crystalline powder. It is sparingly soluble in methylene chloride, slightly soluble in methanol and practically insoluble in water. It dissolves in 1M sodium hydroxide. Telmisartan is chemically described as 4’-[(1,4’-dimethyl-2’-propyl [2,6’-bi-1H-benzimidazol]-1’-yl)methyl]-[1,1’-biphenyl]-2-carboxylic acid. Its empirical formula is C 33 H 30 N 4 O 2 and its structural formula is: Telmisartan and amlodipine tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white or almost white powder, freely soluble in methanol, sparingly soluble in ethanol, slightly soluble in 2-propanol and in water. Amlodipine besylate’s chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its empirical formula is C 20 H 25 ClN 2 O 5 •C 6 H 6 O 3 S and its structural formula is: Telmisartan and amlodipine tablets are formulated in four strengths for oral administration with a combination of amlodipine besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with 40 mg, or 80 mg of telmisartan provided in the following four combinations: 40/5 mg, 40/10 mg, 80/5 mg, and 80/10 mg. Telmisartan and amlodipine tablets also contain the following inactive ingredients: mannitol, sodium hydroxide, meglumine, povidone, sodium stearyl fumarate, microcrystalline cellulose, corn starch, crospovidone, magnesium stearate, black iron oxide and FD&C blue #1 - Alumium lake. Telmisartan and amlodipine tablets are hygroscopic and require protection from moisture. Telmisartan and amlodipine tablets require protection from light. Structure Structure

Telmisartan and hydrochlorothiazide tablets, USP are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT 1 receptor subtype, and hydrochlorothiazide, a diuretic.Telmisartan, a non-peptide molecule, is chemically described as 4’-[(1,4’-dimethyl-2’-propyl[2,6’-bi-1H-benzimidazol]-1’-yl)methyl]-[1,1’-biphenyl]-2-carboxylic acid. Its empirical formula is C 33 H 30 N 4 O 2 , its molecular weight is 514.63, and its structural formula is: Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7 H 8 ClN 3 O 4 S 2 , and its structural formula is: Telmisartan and hydrochlorothiazide tablets are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively. The tablets contain the following inactive ingredients: mannitol, sodium hydroxide, meglumine, povidone, sodium stearyl fumarate, lactose monohydrate, magnesium stearate. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain ferric oxide red, and the 80 mg/25 mg tablets contain ferric oxide yellow. Telmisartan and hydrochlorothiazide tablets are hygroscopic and require protection from moisture. Telmisartan Hydrochlorothiazide

Temazepam, USP is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1, 3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is: C 16 H 13 ClN 2 O 2 MW = 300.7 Temazepam, USP is a white or almost white crystalline powder, freely slightly soluble in methanol and methylene chloride. Temazepam Capsules USP, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg, and 30 mg Capsules Active Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, sodium lauryl sulphate, magnesium stearate, FD&C Blue 1, D&C Red 28, FD&C Red 40, titanium dioxide, gelatin. 15 mg Capsules Inactive Ingredients: lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, sodium lauryl sulphate, magnesium stearate, FD&C Blue 1, FD&C Red 40, titanium dioxide, gelatin. 22.5 mg Capsules Inactive Ingredients: lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, sodium lauryl sulphate, magnesium stearate, FD&C Blue 1, D&C Red 28, titanium dioxide, gelatin. 30 mg Capsules Inactive Ingredients: lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, sodium lauryl sulphate, magnesium stearate, FD&C Blue 1, FD&C Red 40, D&C Red 28, gelatin, titanium dioxide. The printing ink contains shellac, propylene glycol, potassium hydroxide and iron oxide black. temazepam

Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C 12 H 9 F 3 N 2 O 2 with the following chemical structure: Teriflunomide is a white to off-white powder that is soluble in N, N – Dimethyl formamide and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: lactose monohydrate, corn starch, sodium starch glycolate, hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate. The film coating for the 14 mg tablet is made of hypromellose, titanium dioxide, talc, polyethylene glycol 8000, talc, and FD&C Blue#2 Aluminium Lake. In addition to these, the 7 mg tablet film coating includes iron oxide yellow. Structure

Theophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1 H- Purine -2, 6-dione, 3,7-dihydro-1, 3-dimethyl-, and is represented by the following structural formula: C 7 H 8 N 4 O 2 M.W. 180.17. This product allows a 12-hour dosing interval for a majority of patients and a 24-hour dosing interval for selected patients (see DOSAGE AND ADMINISTRATION section for description of appropriate patient populations). Each extended-release tablet for oral administration contains either 300 mg or 450 mg of anhydrous theophylline. Tablets also contain as inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate and povidone. Structure

Ticagrelor tablets contain ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y 12 ADP-receptor. Chemically it is (1 S ,2 S ,3 R ,5 S )-3-[7-{[(1 R ,2 S )-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3 H -[1,2,3]-triazolo[4,5- d ]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The empirical formula of ticagrelor is C 23 H 28 F 2 N 6 O 4 S and its molecular weight is 522.57. The chemical structure of ticagrelor is: Ticagrelor is a white or off-white to pale pink powder, it is freely soluble in methanol and N, N- dimethylformamide. Practically insoluble in water. Ticagrelor tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: dibasic calcium phosphate, magnesium stearate, mannitol, povidone K30 and sodium starch glycolate. The film coating material contains hypromellose, iron oxide yellow, polyethylene glycol 400, talc and titanium dioxide. Ticagrelor tablets for oral administration contain 60 mg of ticagrelor and the following ingredients: dibasic calcium phosphate, magnesium stearate, mannitol, povidone K30 and sodium starch glycolate. The film coating material contains hypromellose, iron oxide black, iron oxide red, polyethylene glycol 400 and titanium dioxide. structure

Timolol maleate ophthalmic gel forming solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-( tert -butylamino)-3­ [(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is: 25° [α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°). 405 nm Its molecular formula is C 13 H 24 N 4 O 3 S•C 4 H 4 O 4 and its structural formula is: Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate ophthalmic gel forming solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. The pH of the solution is approximately 7.0, and the osmolarity is 260-330 mOsm. Each mL of Timolol maleate ophthalmic gel forming solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of Timolol maleate ophthalmic gel forming solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: gellan gum, tromethamine, mannitol, and water for injection. Preservative: benzododecinium bromide 0.012%. The gel forming solution contains a purified anionic heteropolysaccharide derived from gellan gum. An aqueous solution of gellan gum, in the presence of a cation, has the ability to gel. Upon contact with the precorneal tear film, Timolol maleate ophthalmic gel forming solution forms a gel that is subsequently removed by the flow of tears. timolol-gfs-structure

Tizanidine hydrochloride is a central alpha 2 -adrenergic agonist. Tizanidine hydrochloride is almost white to slightly yellow crystalline substance. Tizanidine is slightly soluble in water and methanol. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. Tizanidine’s molecular formula is C 9 H 8 ClN 5 S-HCl, its molecular weight is 290.2 and its structural formula is: Tizanidine hydrochloride capsules are supplied as 2, 4, and 6 mg capsules for oral administration. Tizanidine hydrochloride capsules contain the active ingredient, tizanidine hydrochloride (2.29 mg equivalent to 2 mg tizanidine base, 4.58 mg equivalent to 4 mg tizanidine base, and 6.87 mg equivalent to 6 mg tizanidine base), and the inactive ingredients, sugar spheres (composed of sucrose, corn starch and purified water), hypromellose, colloidal silicon dioxide, methacrylic acid and ethyl acrylate copolymer, triethyl citrate and talc. Each empty hard gelatin capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate and FD&C Blue No. 1. Additionally, 4 mg and 6 mg empty hard gelatin capsule shell contains FD&C Red No. 3. The printing ink contains shellac, potassium hydroxide and iron oxide black. tizanidine-str.jpg

Tobramycin ophthalmic solution USP, 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each mL of Tobramycin Ophthalmic Solution USP contains: Active : tobramycin 0.3% (3 mg). Preservative : benzalkonium chloride 0.01% (0.1 mg). Inactives : boric acid, sodium sulfate decahydrate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and water for injection. Tobramycin ophthalmic solution USP, 0.3% has a pH range between 7.0 and 8.0 and an osmolality of 260 to 320 mOsm/kg. Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. The chemical structure of tobramycin is: Molecular Weight = 467.52 Molecular Formula: C 18 H 37 N 5 O 9 Chemical name: 0-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4)}-0-{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo -pyranosyl-(1→6)}-2-deoxystreptamine. tobra-struc

Travoprost is a synthetic prostaglandin F analog. Its chemical name is [1R-[1α(Z),2β(1E,3R*),3α,5α]]-7-[3,5-Dihydroxy-2-[3-hydroxy-4-[3-(trifluoromethyl)phenoxy]-1-butenyl]cyclopentyl]-5-heptenoic acid, 1-methylethylester. It has a molecular formula of C 26 H 35 F 3 O 6 and a molecular weight of 500.55 g/mol. The chemical structure of travoprost is: Travoprost USP, is a clear, colorless, viscous oil that is very soluble in acetonitrile, methanol, octanol, and chloroform. It is insoluble in water. Travoprost ophthalmic solution USP, 0.004% (ionic buffered solution) is supplied as clear, colorless sterile, buffered aqueous solution of travoprost, free from foreign visible particles with a pH of approximately 5.7 and an osmolality of approximately 290 mOsmol/kg. Travoprost ophthalmic solution USP, 0.004% (ionic buffered solution) contains Active : travoprost USP, 0.04 mg/mL; Inactives : polyoxyl 40 hydrogenated castor oil, boric acid, propylene glycol, sorbitol, zinc chloride, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection, USP. Preserved in the bottle with an ionic buffered system. travo-structure

Tretinoin Cream USP, 0.1%, containing tretinoin USP, is used for the topical treatment of acne vulgaris. Tretinoin Cream contains tretinoin USP in 0.1% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans -retinoic acid and has the following structure: Image

Tretinoin Cream USP, 0.025%, containing tretinoin USP, is used for the topical treatment of acne vulgaris. Tretinoin Cream contains tretinoin USP in 0.025% by weight, in a hydrophilic cream vehicle of stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-trans -retinoic acid and has the following structure: Image

Triamcinolone acetonide injectable suspension, USP is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THESE FORMULATION ARE SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THESE FORMULATION ARE NOT FOR INTRADERMAL INJECTION. Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, USP with 0.66% sodium chloride for isotonicity, 0.94% (v/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is: MW 434.50 Triamcinolone acetonide occurs as a white to almost-white, crystalline powder and is sparingly soluble in alcohol, methanol and chloroform; very slightly soluble in ether; practically insoluble in water. triamcinolone-structure

Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1 receptor subtype. Valsartan is chemically described as N -(1-oxopentyl)- N -[[2'-(1 H -tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C 24 H 29 N 5 O 3 , its molecular weight is 435.5, and its structural formula is Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pregelatinised starch, poloxamer 188, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol. Additionally Valsartan 40 mg contains Iron Oxide Yellow, Valsartan 80 mg contains Iron Oxide Red, Valsartan 160 mg contains Iron Oxide Yellow, Iron Oxide Red and Valsartan 320 mg contains Iron Oxide Yellow, Iron Oxide Black, Iron Oxide Red. Structure

Valsartan and hydrochlorothiazide tablets are combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT 1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N -(1-oxopentyl)- N -[[2’-(1 H -tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C 24 H 29 N 5 O 3 , its molecular weight is 435.5, and its structural formula is Valsartan USP is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n -butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C 7 H 8 ClN 3 O 4 S 2 , its molecular weight is 297.73, and its structural formula is Valsartan and hydrochlorothiazide tablets, USP are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, red iron oxide, yellow iron oxide, black iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide. Drug product complies with USP Dissolution Test 2. Structure Structure

Vardenafil hydrochloride orally disintegrating tablets are an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific PDE5. Vardenafil HCl, USP is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula: Vardenafil HCl, USP is a white or slightly brown or yellow powder with a molecular weight of 579.1. It is slightly soluble in water, freely soluble in anhydrous Ethanol. Practically insoluble in heptane. Vardenafil hydrochloride orally disintegrating tablets are formulated as white to off white, round, orally disintegrating tablets. Each tablet contains 11.85 mg vardenafil hydrochloride USP (in trihydrate form), which is equivalent to 10 mg vardenafil and the following inactive ingredients: lactose monohydrate, silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide, aspartame, citric acid monohydrate, NAT Peppermint FL WONF SD #491, sodium stearyl fumarate and magnesium stearate. Structure

Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil hydrochloride is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula: Vardenafil hydrochloride is a white or slightly brown or yellow powder with a molecular weight of 579.11. It is slightly soluble in water, freely soluble in anhydrous ethanol. Practically insoluble in heptane. Vardenafil hydrochloride is available as film-coated tablets for oral administration, containing 2.5 mg, 5 mg, 10 mg and 20 mg of vardenafil. The inactive ingredients are microcrystalline cellulose, hydroxypropyl cellulose, crospovidone, talc, colloidal silicon dioxide and magnesium stearate. The colorants include hypromellose, titanium dioxide, polyethylene glycol 6000, iron oxide yellow, iron oxide red, FD&C Yellow No. 5 Tartrazine Aluminum Lake and FD&C Yellow No. 6 Sunset Yellow FCF Aluminum Lake. Structure

Venlafaxine hydrochloride USP is a structurally novel antidepressant for oral administration. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethyl-amino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17 H 27 NO 2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol: water (0.2 M sodium chloride) partition coefficient is 0.43. Compressed tablets contain venlafaxine hydrochloride USP equivalent to 25 mg, 37.5 mg, 50 mg, 75 mg, or 100 mg venlafaxine. Inactive ingredients consist of cellulose, iron oxide red, iron oxide yellow,lactose monohydrate, magnesium stearate and crospovidone. Structure

Venlafaxine hydrochloride extended-release capsules, USP for once-a-day oral administration contains venlafaxine hydrochloride USP, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl) ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17 H 27 NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows: Venlafaxine hydrochloride, USP is a white or almost white powder, it is freely soluble in methanol and water, soluble in anhydrous ethanol and slightly soluble or practically insoluble in acetone. Its octanol: water partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of sugar spheres (composed of sucrose, corn starch and purified water), talc, povidone (k-30), povidone (k-90), ethyl cellulose and hypromellose. The empty hard gelatin capsule shells contain titanium dioxide, gelatin, iron oxide red and iron oxide yellow. In addition, the 37.5 mg empty hard gelatin capsule shells contain iron oxide black. The capsules are printed with edible ink containing shellac, iron oxide red, propylene glycol and simethicone. FDA approved dissolution test specifications differ from USP. venlafaxine-structure

Vilazodone hydrochloride tablets for oral administration contain vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT 1A receptor partial agonist. Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1 H -indol-3-yl)butyl]-1-piperazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99. The structural formula is: In addition to the active ingredient, vilazodone hydrochloride tablets contain microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, FD&C Red No. # 40 Al Lake (10 mg only), FD&C Yellow No. # 6 Al Lake (20 mg only) and FD&C Blue No. # 1 Al Lake (40 mg only). vilazodone-fig.jpg

Zolmitriptan tablets, USP contain zolmitriptan, which is a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5yl]methyl]-2-oxazolidinone and has the following chemical structure: The molecular formula is C 16 H 21 N 3 O 2 , representing a molecular weight of 287.36. Zolmitriptan is a white to off-white crystalline powder that is practically insoluble in water. Zolmitriptan tablets are available as 2.5 mg (yellow) and 5 mg (pink) film coated tablets for oral administration. The film coated tablets contain anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, magnesium stearate. In addition, following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol 4000, yellow iron oxide (2.5 mg strength) and hypromellose, titanium dioxide, talc, polyethylene glycol 6000 and red iron oxide (5 mg strength). Structure

Zolmitriptan orally disintegrating tablets contain zolmitriptan, which is a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone and has the following chemical structure: The empirical formula is C 16 H 21 N 3 O 2 , representing a molecular weight of 287.36. Zolmitriptan is a white to off-white crystalline powder that is freely soluble in N,N-dimethyl formamide, dimethyl sulfoxide and practically insoluble in water. Zolmitriptan orally disintegrating tablets are available as 2.5 mg and 5 mg white to off-white uncoated tablets. The orally disintegrating tablets contain mannitol, microcrystalline cellulose, crospovidone, aspartame [ see Warnings and Precautions (5.9) ], sodium stearyl fumarate, colloidal silicon dioxide, magnesium stearate, orange flavor, modified food starch and triacetin.