advagen pharma ltd - Medication Listings

The active ingredient in gabapentin oral solution is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The Structural formula of gabapentin is: Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (noctanol/0.05M phosphate buffer) at pH 7.4 is - 1.25. Gabapentin oral solution contains 250 mg of gabapentin per 5 mL (50 mg per mL) and the following ingredients: acesulfame potassium, banana flavor NAT & ART, glycerin, methylparaben, propylparaben, propylene glycol, saccharin sodium and purified water. May also contain sodium hydroxide or hydrochloric acid for pH adjustment. Chemical Structure

Gabapentin is described as 1-(aminomethyl) cyclohexaneacetic acid with a molecular formula of C 9 H 17 NO 2 and a molecular weight of 171.24. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. 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 -1.25. It has the following structural formula: Gabapentin film-coated tablet, USP for oral administration contains 600 mg and 800 mg of gabapentin. In addition, each tablet contains the following inactive ingredients: copovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol and titanium dioxide. Chemical Structure

Carvedilol is a nonselective β-adrenergic blocking agent with α 1 -blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure: Carvedilol tablets is a white, oval, film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. The 3.125mg, 6.25-mg, 12.5-mg, and 25-mg tablets are film coated tablets. Inactive ingredients consist of anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol 800 NF and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24 H 26 N 2 O 4 . It is freely soluble in dimethyl sulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). carvedilol chemical structure

Triamterene and hydrochlorothiazide tablets, USP combine triamterene, a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Each Triamterene and hydrochlorothiazide tablet, USP contains: Triamterene, USP ............................................................................... 75 mg Hydrochlorothiazide, USP .................................................................. 50 mg OR Triamterene, USP ................................................................................ 37.5 mg Hydrochlorothiazide, USP .................................................................. 25 mg Triamterene and hydrochlorothiazide tablets, USP for oral administration contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake, Hypromellose, magnesium stearate and microcrystalline cellulose. Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene is practically insoluble in water, benzene, chloroform, ether and dilute alkali hydroxides. It is soluble in formic acid and sparingly soluble in methoxyethanol. Triamterene is very slightly soluble in acetic acid, alcohol and dilute mineral acids. Its molecular weight is 253.27. Its structural formula is: Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H -1,2,4,benzothiadiazine-7- sulfonamide 1,1-dioxide. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution, n-butylamine and dimethylformamide. It is sparingly soluble in methanol and insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.73. Its structural formula is: Triamterene Structural Formula Hydrochlorothiazide Structural Formula

Sildenafil tablets USP, an oral therapy for erectile dysfunction, consist of citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H - pyrazolo[4,3- d ]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate is a white to off-white powder, slightly soluble in water and methanol with a molecular weight of 666.7. Sildenafil tablets, USP are formulated as blue, film-coated oval biconvex tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: crospovidone, hydrophobic colloidal silica, hypromellose, lactose monohydrate, magnesium stearate VG, microcrystalline cellulose, titanium dioxide, triacetin and FD&C Blue# 2/ Indigo Carmine Aluminium. Sildenafil citrate Structure

Sildenafil Tablets, USP phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA ® for erectile dysfunction. Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H -pyrazolo [4,3- d ] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate is a white or almost white, slightly hygroscopic crystalline powder. Slightly soluble in water & methanol, practically insoluble in hexane and a molecular weight of 666.7. Sildenafil tablets: Sildenafil tablets is white round, biconvex film coated tablets, debossed with R on one side and 20 on the other, containing sildenafil citrate equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate , each tablet contains the following inactive ingredients: Crospovidone, Hypromellose, Hydrophobic colloidal silica, Lactose monohydrate, Magnesium stearate, Microcrystalline cellulose, Titanium dioxide, and Triacetin. Structure Formula

Acetazolamide, an inhibitor of the enzyme carbonic anhydrase, is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in water and slightly soluble in alcohol. The chemical name for acetazolamide is N -(5-Sulfamoyl-1,3,4-thiadiazol-2-yl)-acetamide and has the following chemical structure: Molecular Weight: 222.25 Molecular Formula: C 4 H 6 N 4 O 3 S 2 Acetazolamide is available as oral tablets containing 125 mg and 250 mg of acetazolamide, respectively, and the following inactive ingredients: maize starch, gelatin, glycerin, lactose monohydrate, magnesium stearate, sodium starch glycolate and talc. "Image Description"

Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H -dibenzo[a,d] cycloheptene-Δ 5 , γ-propylamine hydrochloride. It has the following structural formula: Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients include colloidal silicon dioxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, hypromellose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, maize starch, polyethylene glycol, talc, titanium dioxide, iron oxide red and iron oxide yellow. FDA approved dissolution test specifications differ from USP. Structure

Aripiprazole, is an atypical antipsychotic drug that is available as aripiprazole oral solution. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4- dihydrocarbostyril. The empirical formula is C 23 H 27 Cl 2 N 3 O 2 and its molecular weight is 448.38. The chemical structure is: Aripiprazole Oral Solution is a clear solution with orange flavour, available in a concentration of 1 mg/mL. The inactive ingredients for this solution include disodium edetate, glycerin, malic acid, methylparaben, propylene glycol, propylparaben, orange flavor NAT and ART, sucralose, and purified water. Sodium hydroxide solution may be added for adjustment of pH. 8f42eff5-figure-01

Baclofen is a gamma-aminobutyric acid (GABA-ergic) agonist available as 5 mg/5 mL solution for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is: Molecular formula is C 10 H 12 CINO 2 . Molecular Weight is 213.66. Baclofen, USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The inactive ingredients of baclofen oral solution are: carboxymethyl cellulose sodium, glycerin, grape flavor NAT & ART, methylparaben, propylparaben, purified water, and sucralose. May also contain sodium hydroxide or hydrochloric acid for pH adjustment. image description

Baclofen is a gamma-aminobutyric acid (GABA-ergic) agonist available as 10 mg/5 mL solution for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is: Molecular formula is C 10 H 12 ClNO 2 . Molecular Weight is 213.66. Baclofen, USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The baclofen oral solution inactive ingredients are: glycerin, methyl paraben, propyl paraben, sucralose, sodium carboxymethylcellulose, grape flavor, hydrochloride acid, sodium hydroxide, purified water "Image Description"

Benazepril hydrochloride USP is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)-3- phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H -1-(3S)-benzazepine- 1-acetic acid monohydrochloride; its structural formula is Its empirical formula is C 24 H 28 N 2 O 5 ·HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n -butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide’s chemical name is 6-chloro-3,4-dihydro-2 H -1,2,4- benzothiadiazine-7-sulfonamide 1,1-dioxide; its structural formula is: Its empirical formula is C 7 H 8 ClN 3 O 4 S 2 , and its molecular weight is 297.73. Hydrochlorothiazide is a thiazide diuretic. Benazepril HCl and Hydrochlorothiazide is a combination of benazepril and hydrochlorothiazide USP. The tablets are formulated for oral administration with a combination of 10 or 20 mg of benazepril and 12.5 or 25 mg of hydrochlorothiazide USP. The inactive ingredients of the tablets are cellulose compounds, crospovidone, hydrogenated castor oil, iron oxides (10/12.5 mg, 20/12.5 mg, and 20/25 mg tablets), lactose, polyethylene glycol, talc, and titanium dioxide. image description image description

Bisoprolol fumarate is a synthetic, beta 1 -selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol( E )-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C 18 H 31 NO 4 ) 2 •C 4 H 4 O 4 and its structure is: Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol, and chloroform. Bisoprolol fumarate tablets, USP are available as 2.5 mg, 5 mg and 10 mg tablets for oral administration. Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 5 mg tablets also contain FD&C Red # 40/Allura Red AC aluminum lake, FD&C Yellow # 6/Sunset Yellow FCF aluminum lake. FDA approved dissolution test specifications differ from USP. chemical structure

Buprenorphine Sublingual Tablets are a white to off white round shaped tablet debossed with ˄ on 2 mg and ˄ on 8 mg on one side and plain on the other side. B9 B10 It contains buprenorphine HCl, a partial agonist at the mu-opioid receptor, and is available in two dosage strengths, 2 mg buprenorphine and 8 mg buprenorphine (as the free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 8.64 mg buprenorphine hydrochloride USP). Each tablet also contains lactose monohydrate, mannitol, corn starch, citric acid anhydrous, sodium citrate dihydrate and magnesium stearate. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan -2-ol hydrochloride. It has the following chemical structure: Buprenorphine HCl has the molecular formula C 29 H 41 NO 4 ∙HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol and practically insoluble in cyclohexane. "Image Description"

Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1­ piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula C 21 H 31 N 5 O 2 • HCl is represented by the following structural formula: Buspirone hydrochloride tablets are supplied as tablets for oral administration containing 5 mg, 7.5 mg, 10 mg, 15 mg, or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are provided in multi-scored tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Buspirone hydrochloride tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and croscarmellose sodium. structure

Carbidopa and Levodopa extended-release tablets, USP are extended-release oral dosage form and are combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-α-hydrazino- α -methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C 10 H 14 N 2 O 4 •H 2 O, and its structural formula is: Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L- α -amino- β -(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C 9 H 11 NO 4 , and its structural formula is: Carbidopa and levodopa extended-release tablets, USP are supplied as extended-release tablets containing either 50 mg of carbidopa and 200 mg of levodopa, or 25 mg of carbidopa and 100 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide. Carbidopa and levodopa extended-release tablets, USP 25 mg/100 mg and 50 mg/ 200 mg also contain FD&C red 40 Alu lake and FD&C blue 2 Alu lake. The 25 mg/100 mg tablet is supplied as light purple to purple, dappled, oval, uncoated tablets, debossed with “Λ50” on one side and plain on other. The 50 mg/200 mg tablet is supplied as light purple to purple, dappled, oval, uncoated tablets, debossed with “Λ51” on one side and plain on other. Carbidopa and levodopa extended-release tablets are polymeric-based drug delivery system that controls the release of carbidopa and levodopa as it slowly erodes. Carbidopa and levodopa extended-release tablets 25 mg/100 mg are available to facilitate titration when 100 mg steps are required. FDA approved dissolution test specifications differ from USP. image description image description

Carbidopa and Levodopa tablets, USP are a combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (—)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C 10 H 14 N 2 O 4 •H 2 O, and its structural formula is: Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.3. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (—)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C 9 H 11 NO 4 , and its structural formula is: Carbidopa and levodopa tablets, USP are supplied in three strengths: Carbidopa and levodopa tablets USP 10/100 mg containing 10 mg of carbidopa and 100 mg of levodopa. Carbidopa and levodopa tablets USP 25/100 mg containing 25 mg of carbidopa and 100 mg of levodopa. Carbidopa and levodopa tablets USP 25/250 mg containing 25 mg of carbidopa and 250 mg of levodopa. Inactive ingredients are hydroxypropyl cellulose, crospovidone, microcrystalline cellulose, and magnesium stearate. Carbidopa and levodopa tablets 10 mg/100 mg and 25 mg/250 mg also contain FD&C Blue 2 aluminium lake. Carbidopa and levodopa tablets 25 mg/100 mg also contain D&C Yellow 10 aluminium lake. FDA approved dissolution test specifications differ from USP. Image of Carbidopa Chemical Structure Image of Levodopa Chemical Structure

Rx only DESCRIPTION Cevimeline is cis -2’-methylspiro{1-azabicyclo [2.2.2] octane-3, 5’-[1,3] oxathiolane} hydrochloride, hydrate (2:1). Its empirical formula is C 10 H 17 NOS.HCl.½ H 2 O, and its structural formula is: Cevimeline has a molecular weight of 244.79. It is a white to off white crystalline powder with a melting point range of 201 to 203 o C. It is freely soluble in alcohol and chloroform, very soluble in water, and virtually insoluble in ether. The pH of a 1% solution ranges from 4.6 to 5.6. Cevimeline hydrochloride is available as 30 mg capsules for oral administration. Inactive ingredients include lactose monohydrate, hydroxypropyl cellulose, and magnesium stearate, gelatin, titanium dioxide, sodium lauryl sulphate, shellac, propylene glycol, black iron oxide and potassium hydroxide. The structural formula for Cevimeline is cis -2’-methylspiro{1-azabicyclo [2.2.2] octane-3, 5’-[1,3] oxathiolane} hydrochloride, hydrate (2:1). Its empirical formula is C10H17NOS.HCl.

Chlorpromazine is 10-(3-dimethylaminopropyl)-2-chlorphenothiazine, a dimethylamine derivative of phenothiazine. It is present in an oral concentrate as the hydrochloride salt. Concentrate - Each mL of clear, colorless to pale yellow solution contains chlorpromazine hydrochloride USP, 30 or 100 mg. Inactive ingredients consist of potassium sorbate, edetate calcium disodium, sodium citrate, anhydrous citric acid, sucralose and purified water. "Image Description"

Clomiphene citrate tablets, USP is an orally administered, nonsteroidal, ovulatory stimulant designated chemically as 2-[p-(2-chloro-1,2-diphenylvinyl)phenoxy] triethylamine citrate (1:1). It has the molecular formula of C 26 H 28 CINO•C 6 H 8 O 7 and a molecular weight of 598.08. It is represented structurally as: Clomiphene citrate is a white to pale yellow, essentially odorless, crystalline powder. It is freely soluble in methanol; soluble in ethanol; slightly soluble in acetone, water, and chloroform; and insoluble in ether. Clomiphene citrate is a mixture of two geometric isomers [cis (zuclomiphene) and trans (enclomiphene)] containing between 30% and 50% of the cis-isomer. Each white to off-white scored tablet contains 50 mg clomiphene citrate USP. The tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, and sucrose. FDA approved dissolution test specifications differ from USP. image description

Clonazepam Tablets, USP, a benzodiazepine, is available as scored tablet with debossing Λ containing 0.5 mg of clonazepam and unscored tablets with debossing Λ and Λ containing 1 mg or 2 mg of clonazepam respectively. 66 67 69 Each tablet also contains lactose monohydrate, polyethylene glycol, microcrystalline cellulose, croscarmellose sodium and magnesium stearate, with the following colourants: 0.5 mg-FD & C Yellow 6 Al Lake, D & C Yellow 10 Al Lake; 1 mg-FD & C Blue 1 Al lake and FD & C Blue 2 Al lake Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro- 2H -1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula: image description

Desvenlafaxine extended-release tablets are an extended-release tablets for oral administration that contain desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive disorder. Desvenlafaxine is designated RS -4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol and has the empirical formula of C 16 H 25 NO 2 (free base) and C 16 H 25 NO 2 •C 4 H 6 O 4 •H 2 O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below. Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol:aqueous system (at pH 7.0) partition coefficient is 0.21. Desvenlafaxine extended-release tablets are formulated as an extended-release tablet for once-a-day oral administration. Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively. Inactive ingredients for the 25 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide yellow and iron oxide red. Inactive ingredients for the 50 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, FD&C Red #40 and FD&C Yellow #6. Inactive ingredients for the 100 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide yellow, iron oxide red and iron oxide black. image description

Dexamethasone Tablets, USP are available for oral administration containing either 0.5 mg, 0.75 mg, 1 mg, 1.5 mg, 2 mg, 4 mg or 6 mg of dexamethasone, USP. Each tablet contains the following inactive ingredients: Anhydrous lactose, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, D&C Yellow #10 Aluminum lake (0.5 mg and 4 mg), FD&C Blue #1 Aluminum lake (0.75 mg, 4 mg and 6 mg), FD&C Yellow #6 Aluminum lake (0.5 mg), FD&C Red #40 Aluminum lake (1.5 mg), D&C Red #27 Aluminum lake (1.5 mg), and Ferric Oxide Yellow (1 mg). Dexamethasone, USP, a synthetic adrenocortical steroid, is a white or almost- white crystalline powder. It is stable in air. It is practically insoluble in water. The empirical formula is C 22 H 29 FO 5 . The molecular weight is 392.47 g/mol. It is designated chemically as (11β,16α)-9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione and the structural formula is: Meets USP Dissolution Test 2. chemstruct

Diclofenac potassium is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25. Its molecular formula is C 14 H 10 C l2 NKO 2 . The structural formula is: Diclofenac potassium is a faintly yellowish white to light beige, virtually odorless, slightly hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac potassium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each diclofenac potassium tablet, USP intended for oral administration contains 25 mg and 50 mg of diclofenac potassium, USP. In addition, each tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide. Diclofenac Potassium tablet, Chemical Structure

Diclofenac sodium ophthalmic solution, 0.1% is a sterile, topical, nonsteroidal, anti-inflammatory product for ophthalmic use. Diclofenac sodium is designated chemically as 2-[(2,6 dichlorophenyl) amino] benzeneacetic acid, monosodium salt, with an empirical formula of C 14 H 10 C l2 NO 2 Na. The structural formula of diclofenac sodium is: Diclofenac sodium ophthalmic solution is available as a sterile solution, which contains diclofenac sodium 0.1%(1mg/mL). Inactive Ingredients: polyoxyl 35 castor oil, Boric acid, tromethamine, sorbic acid (2 mg/mL), edetate disodium (1 mg/mL), and purified water. Diclofenac sodium is a faintly yellow-white to light beige, slightly hygroscopic crystalline powder. It is freely soluble in methanol, sparingly soluble in water, very slightly soluble in acetonitrile, and insoluble in chloroform and in 0.1N hydrochloric acid. Its molecular weight is 318.14. Diclofenac sodium ophthalmic solution, 0.1% is a clear, colourless solution with an osmolality between 270 mOsmols/kg to 310 mOsmols/kg, buffered at a pH between 6.0 to 8.0. Diclofenac sodium ophthalmic solution has a faint characteristic odor of castor oil. Image Description

Diclofenac sodium is a benzene-acetic acid derivative. Diclofenac sodium delayed-released tablets USP are available as delayed-release tablets of 25 mg, 50 mg and 75 mg for oral administration. Diclofenac sodium is a white or slightly yellowish crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C 14 H 10 Cl 12 NNaO 2 , and it has the following structural formula The inactive ingredients in diclofenac sodium delayed-release tablets USP include: croscarmellose sodium, hydroxypropyl methylcellulose, iron oxide red, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, povidone, talc and titanium dioxide. Chemical structure

Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available as dicyclomine hydrochloride tablets, USP for oral use containing 20 mg and 40 mg dicyclomine hydrochloride USP. It also contain inactive ingredients: lactose monohydrate, hypromellose, pregelatinized maize starch, FD & C Blue 1 Alu.lake, colloidal silicon dioxide and magnesium stearate. Dicyclomine hydrochloride is [bicyclohexyl]-1- carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of C 19 H 35 NO 2 •HCl and the following structural formula: Molecular weight: 345.95 Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether. FDA approved dissolution test specifications differ from USP. Structure of Dicyclomine Hydrochloride

Dihydroergotamine mesylate is ergotamine hydrogenated in the 9,10 position as the mesylate salt. Dihydroergotamine mesylate is known chemically as ergotaman-3', 6', 18-trione, 9,10-dihydro-12'-hydroxy-2'-methyl-5'- (phenylmethyl)-, (5'α)-, monomethane-sulfonate. Its molecular weight is 679.78 and its empirical formula is C 33 H 37 N 5 O 5 •CH 4 O 3 S. The chemical structure is: Dihydroergotamine mesylate nasal spray is provided for intranasal administration as a clear, colorless to light yellow aqueous solution in an amber glass vial containing: dihydroergotamine mesylate.......................................................................... ..4 mg caffeine, anhydrous......................................................................................... 10 mg dextrose, anhydrous ....................................................................................... 50 mg carbon dioxide......................................................................................................qs purified water............................................................................................... qs 1 mL Each milliliter contains Dihydroergotamine mesylate……4 mg (equivalent to 3.43 mg dihydroergotamine) image description

Dorzolamide hydrochloride ophthalmic solution is a carbonic anhydrase inhibitor formulated for topical ophthalmic use. Dorzolamide hydrochloride is described chemically as: (4 S-trans )-4-(ethylamino)-5,6-dihydro-6-methyl-4 H -thieno[2,3- b ]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is α 25° (C=1, water) = ~ -17°. 405 Its empirical formula is C 10 H 16 N 2 O 4 S 3 •HCl and its structural formula is: Dorzolamide hydrochloride has a molecular weight of 360.9 and a melting point of about 264°C. It is a white to off-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. Dorzolamide hydrochloride ophthalmic solution is supplied as a sterile, isotonic, buffered, slightly viscous, aqueous solution of dorzolamide hydrochloride. The pH of the solution is approximately 5.4 to 5.9, and the osmolarity is 260-330 mOsmoles/kg. Each mL of dorzolamide hydrochloride ophthalmic solution 2% contains 20 mg dorzolamide (equivalent to 22.3 mg of dorzolamide hydrochloride). Inactive ingredients are hydroxyethyl cellulose, mannitol, sodium citrate dihydrate, sodium hydroxide (to adjust pH) and water for injection. Benzalkonium chloride 0.0075% is added as a preservative. Dorzolamide hydrochloride ophthalmic solution Chemical Structure

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

The active component of fluticasone propionate nasal spray USP is fluticasone propionate USP, a corticosteroid having the chemical name S-(fluoromethyl)6α,9-difluoro-11β-17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure: Fluticasone propionate is a white to off-white powder with a molecular weight of 500.6 and the molecular formula is C 25 H 31 F 3 O 5 S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Fluticasone propionate nasal spray, 50 mcg is an aqueous suspension of microfine fluticasone propionate for topical administration to the nasal mucosa by means of a metering, atomizing spray pump. Fluticasone propionate nasal spray also contains 0.02% w/w benzalkonium chloride, dextrose, microcrystalline cellulose and carboxymethylcellulose sodium, 0.25% w/w phenylethyl alcohol and polysorbate 80 and has a pH between 5 and 7. After initial priming, each actuation delivers 50 mcg of fluticasone propionate in 100 mg of formulation through the nasal adapter. image description

Guanfacine Tablets, USP are centrally acting antihypertensive with α 2 -adrenoceptor agonist properties in tablet form for oral administration. The chemical name of guanfacine hydrochloride is N-amidino-2-(2,6-dichlorophenyl) acetamide hydrochloride and its molecular weight is 282.56. Its structural formula is: Guanfacine hydrochloride is a white to off-white powder; sparingly soluble in water and alcohol and slightly soluble in acetone. The inactive ingredients in each tablet are crospovidone, fumaric acid, lactose monohydrate, magnesium stearate, pregelatinized maize starch. Additionally 1 mg tablet contains FD & C blue 1 Alu lake. FDA approved dissolution test specifications differ from USP. Image

Haloperidol is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chlorophenyl)-4-hydroxy-piperidino]-4'-fluorobutyrophenone and it has the following structural formula: Haloperidol oral solution USP (concentrate) contains 2 mg per mL haloperidol (as the lactate). Inactive ingredients: Lactic acid, methylparaben, propylparaben, propylene glycol, and purified water. image description

The active ingredient in Ipratropium Bromide Nasal Solution is ipratropium bromide (as the monohydrate). It is an anticholinergic agent chemically described as 8-azoniabicyclo [3.2.1] octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide monohydrate (3-endo, 8-syn)-: a synthetic quaternary ammonium compound, chemically related to atropine. The structural formula is: ipratropium bromide C 20 H 30 BrNO 3 • H 2 O Mol. Wt. 430.4 Ipratropium bromide is a white to off-white crystalline substance, freely soluble in water and methanol, sparingly soluble in ethanol, and insoluble in non-polar media. In aqueous solution, it exists in an ionized state as quaternary ammonium compound. Ipratropium Bromide Nasal Solution, 0.06% is a metered-dose, manual pump spray unit which delivers 42 mcg (70 mcL) ipratropium bromide per spray on an anhydrous basis in an isotonic, aqueous solution with pH adjusted to 4.7 with hydrochloric acid and/or sodium hydroxide (if needed). It also contains benzalkonium chloride, edetate disodium, purified water and sodium chloride. Each bottle contains 165 metered sprays. image description

The active ingredient in Ipratropium Bromide Nasal Solution is ipratropium bromide (as the monohydrate). It is an anticholinergic agent chemically described as 8-azoniabicyclo (3.2.1) octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide monohydrate (3-endo, 8-syn)-: a synthetic quaternary ammonium compound, chemically related to atropine. The structural formula is: ipratropium bromide C 20 H 30 BrNO 3 • H 2 O Mol. Wt. 430.4 Ipratropium bromide is a white to off-white crystalline substance, freely soluble in water and methanol, sparingly soluble in ethanol, and insoluble in non-polar media. In aqueous solution, it exists in an ionized state as a quaternary ammonium compound. Ipratropium Bromide Nasal Solution, 0.03% is a metered-dose, manual pump spray unit which delivers 21 mcg (70 mcL) ipratropium bromide per spray on an anhydrous basis in an isotonic, aqueous solution with pH adjusted to 4.7 with hydrochloric acid and/or sodium hydroxide (if needed). It also contains benzalkonium chloride, edetate disodium, purified water and sodium chloride. Each bottle contains 345 metered sprays. image description

Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate, an organic nitrate whose structural formula is and whose molecular weight is 236.14. The organic nitrates are vasodilators, active on both arteries and veins. Isosorbide dinitrate is a white, crystalline powder compound which is stable in air and in solution, has a melting point of 69°C to 72°C and optically active. Isosorbide dinitrate is very soluble in acetone, sparingy soluble in alcohol and very slightly soluble in water. Each Isosorbide dinitrate tablet contains 5 mg, 10 mg, 20 mg, 30 mg or 40 mg of isosorbide dinitrate. The inactive ingredients in each tablet are microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate. The 5mg, 10 mg, 20 mg and 30 mg dosage strengths also contain anhydrous lactose and sodium starch glycolate Type A. Additionally 5 mg contains FD & C red 40 Al lake. 10 mg, 20mg, 30 mg and 40 mg contains FD & C Blue 1 Al lake and D & C Yellow 10 Al lake. FDA approved dissolution test specifications differ from USP. Isosorbide Dinitrate Chemical Structure

Ivermectin tablet is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of Streptomyces avermitilis . Ivermectin is a mixture containing at least 90% 5- O -demethyl-22,23-dihydroavermectin A 1a and less than 10% 5- O demethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)avermectin A 1a , generally referred to as 22,23- dihydroavermectin B 1a and B 1b , or H 2 B 1a and H 2 B 1b , respectively. The respective empirical formulas are C 48 H 74 O 14 and C 47 H 72 O 14 , with molecular weights of 875.10 and 861.07, respectively. The structural formulas are: Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about 155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol. Ivermectin tablets are available in 3 mg and 6 mg tablets containing the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, pregelatinized starch, magnesium stearate. image description

Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha 1 -adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride, USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure: Labetalol hydrochloride, USP has the molecular formula C 19 H 24 N 2 O 3 • HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets, USP, for oral administration, contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, maize starch, hypromellose (Methocel E5), sodium starch glycolate, magnesium stearate, titanium dioxide, polyethylene glycol, polysorbate 80, hypromellose (3 mPas) and hypromellose (6 mPas) Image

Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha 1 -adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride, USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure: Labetalol hydrochloride, USP has the molecular formula C 19 H 24 N 2 O 3 • HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets, USP, for oral administration, contain 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, maize starch, hypromellose (Methocel E5), sodium starch glycolate, magnesium stearate, titanium dioxide, polyethylene glycol, polysorbate 80, hypromellose (3 mPas) and hypromellose (6 mPas) "Image Description"

Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous) contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous) contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula: The molecular formula of lidocaine is C 14 H 22 N 2 O. The molecular weight is 234.34. Chemical Structure

Each 5 mL of solution for oral administration contains lithium ion (Li + ), 8 mEq (equivalent to amount of lithium in 300 mg of lithium carbonate), alcohol 0.3% v/v and the following other inactive ingredients: citric acid, purified water, artificial cherry flavor, sodium benzoate and sorbitol solution. May also contain sodium hydroxide for pH adjustment. Lithium oral solution, USP is a palatable oral dosage form of lithium ion. It is prepared in solution from trilithium citrate tetrahydrate and citric acid in a ratio approximately di-lithium citrate. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. The empirical formula for Lithium Citrate is C 6 H 5 Li 3 O 7 ; molecular weight 209.93. Lithium acts as an antimanic.

Loperamide hydrochloride, 4-(p-chlorophenyl)-4-hydroxy-N, N-dimethyl-α,α-diphenyl-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use. Loperamide hydrochloride is available in 2 mg capsules. The inactive ingredients are: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate gelatin, titanium dioxide, ferric oxide black, ferric oxide red, ferric oxide yellow, sodium lauryl sulfate, shellac, propylene glycol and potassium hydroxide. FDA approved dissolution specification differs from the USP dissolution specification. image description

Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1 -adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1- (Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP is available as 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg tablets for oral administration containing 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg metoprolol tartrate. Inactive Ingredients : Tablets contain lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate. "Image Description"

Nitroglycerin sublingual tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg , or 0.6 mg nitroglycerin; as well as lactose monohydrate, colloidal silicon dioxide, sodium starch glycolate, calcium stearate and glyceryl behenate. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is: Molecular weight: 227.09 Nitroglycerin Chemical Structure

Nortriptyline hydrochloride is 1-propanamine,3-(10,11-dihydro- 5H -dibenzo [ a,d ]cyclohepten-5-ylidene)- N-methyl-hydrochloride. The structural formula is as follows: Molecular weight – 299.84 Molecular formula – C 19 H 21 N. HCl The oral solution contains nortriptyline hydrochloride equivalent to 10 mg/5 mL (38.0 μmol) of the base and alcohol 4% v/v. It also contains artificial cherry flavor, citric acid, purified water, sodium benzoate, sodium hydroxide and sorbitol. "Image Description"

Oxcarbazepine tablets USP is an AED available as 150 mg, 300 mg and 600 mg film-coated tablets for oral administration. Oxcarbazepine is 10,11-Dihydro-10-oxo-5 H- dibenz[b, f ]azepine-5-carboxamide, and its structural formula is Oxcarbazepine is a white to faintly orange crystalline powder. It is sparingly soluble in chloroform, soluble in acetic acid and practically insoluble in water. Its molecular weight is 252.27 g/mol. Oxcarbazepine film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, polyethylene glycol and iron oxide yellow. "Image Description"

Oxcarbazepine is an AED available as a 300 mg/5mL (60 mg/mL) oral suspension. Oxcarbazepine is 10,11-Dihydro-10-oxo-5 H -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 g/mol. Oxcarbazepine oral suspension, USP contains the following inactive ingredients: malic acid, microcrystalline cellulose and carboxymethyl cellulose sodium, methyl paraben, propyl paraben, polyethylene glycol, propylene glycol, purified water, sodium saccharin, sorbitol, yellow plum lemon flavor. Sodium hydroxide solution may be added for adjustment of pH. Oxcarbazepine chemical structural.

Potassium chloride extended-release tablets USP, 10 mEq are an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Potassium chloride extended-release tablets USP, 15 mEq are an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,125 mg of microencapsulated potassium chloride, USP equivalent to 15 mEq of potassium in a tablet. Potassium chloride extended-release tablets USP, 20 mEq are an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Potassium chloride extended-release is a tablet formulation (not enteric-coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, potassium chloride extended-release tablet begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within one minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride. Inactive Ingredients: croscarmellose sodium, ethylcellulose, microcrystalline cellulose, talc and triacetin. FDA approved acceptance criteria for assay differs from USP test. FDA approved dissolution test specifications differ from USP.

Potassium chloride extended-release tablets are a solid oral dosage form of potassium chloride containing 750 mg, 1125 mg and 1500 mg of potassium chloride, USP, equivalent to 10 mEq, 15 mEq and 20 mEq of potassium, respectively, in a film-coated matrix tablet. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP, occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. The 10 mEq, 15 mEq and 20 mEq tablets contain colloidal silicon dioxide, magnesium stearate, paraffin, polyethylene glycol, polyvinyl acetate, povidone, sodium lauryl sulphate, polyvinyl alcohol, talc, titanium dioxide, triethyl citrate, D&C yellow # 10 (for 15 mEq) and FD&C yellow # 6 (for 15 mEq). FDA approved dissolution test specifications and assay sample preparation method differs from USP.

Pregabalin extended-release tablets are for oral use and contain pregabalin. 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 extended-release tablets are administered orally and contain 82.5, 165, or 330 mg of pregabalin, along with Kollidon SR (polyvinyl acetate, povidone, sodium lauryl sulphate, and silica), polyethylene oxide, carbomer, microcrystalline cellulose, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc and polyethylene glycol. The 82.5 mg also includes FD&C Blue # 1/Brilliant Blue FCF Aluminum lake, FD&C Blue # 2/ Indigo Carmine Aluminum Lake, FD&C Red # 40/Allura Red AC Aluminum Lake, FD&C Yellow # 5/Tartrazine Aluminum Lake; 165 mg includes iron oxide yellow and iron oxide red; 330 mg includes FD&C Red # 40/Allura Red AC Aluminum Lake and FD&C Yellow # 6/Sunset Yellow FCF Aluminum Lake. "Image Description"