granules pharmaceuticals inc. - Medication Listings

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, crystalline substance, very slightly soluble in water, slightly soluble in methanol, dimethylformamide, dimethylacetamide and alcohol, practically insoluble in chloroform and acetone, and 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. Inactive ingredients in the formulations are: anhydrous lactose, lactose monohydrate, magnesium stearate and silicified microcrystalline cellulose. The empty gelatin capsules contain gelatin and titanium dioxide; the 2 mg capsules contain FD&C red # 3 and FD&C blue # 1 and the 5 mg capsules contain FD&C Red # 40 and FD&C Blue # 1. In addition, capsule imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. Meets USP Dissolution Test 2. molecular-strucrure-jpg

Ramelteon is an orally active hypnotic chemically designated as ( S )- N -[2-(1,6,7,8-tetrahydro-2 H -indeno-[5,4- b ]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the ( S )-enantiomer, with an empirical formula of C 16 H 21 NO 2 , molecular weight of 259.34, and the following chemical structure: Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11. Each Ramelteon tablet includes the following inactive ingredients: copovidone, corn starch, hydroxypropyl cellulose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, and titanium dioxide. ramelteon-structure-jpg

Trospium Chloride Extended-Release Capsules are an extended-release formulation of trospium chloride, a quaternary ammonium compound with the chemical name of Spiro [8- azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5α). The empirical formula of trospium chloride is C 25 H 30 ClNO 3 and its molecular weight is 428. The structural formula of trospium chloride is represented below: Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. The compound’s solubility in water is approximately 1 g/2 mL. Trospium Chloride Extended-Release Capsules contain 60 mg of trospium chloride, a muscarinic antagonist, for oral administration. Each capsule also contains the following inactive ingredients: corn starch, ethylcellulose, FD&C Blue# 1, FD&C Red# 40, FD&C Yellow# 6, gelatin, hypromellose, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sucrose, talc, titanium dioxide, triacetin and triethyl citrate. In addition, capsule printing ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. trospium-structure

Valganciclovir hydrochloride for oral solution contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against CMV. Valganciclovir is available as a powder for oral solution, which when constituted with water as directed contains 50 mg/mL valganciclovir free base. The inactive ingredients of valganciclovir hydrochloride for oral solution are mannitol, sodium benzoate, sucralose, tartaric acid and tutti-frutti flavoring. Valganciclovir HCl, USP is a white to off-white crystalline powder with a molecular formula of C 14 H 22 N 6 O 5 ·HCl and a molecular weight of 390.83. The chemical name for valganciclovir HCl is L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl) methoxy]-3-hydroxypropyl ester, monohydrochloride. Valganciclovir HCl is a polar hydrophilic compound with a solubility of 70 mg/mL in water at 25°C at a pH of 7 and an n-octanol/water partition coefficient of 0.0095 at pH 7. The pKa for valganciclovir HCl is 7.6. The chemical structure of valganciclovir HCl is: All doses in this insert are specified in terms of valganciclovir. valganciclovir-structure-jpg

Venlafaxine hydrochloride extended-release capsules, USP for once-a-day oral administration that contains venlafaxine hydrochloride, 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 molecular 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 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. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, hydroxypropyl methylcellulose, sugar spheres and talc. The empty capsule shells contain ferric oxide red, gelatin, sodium lauryl sulphate and titanium dioxide. In addition, the 37.5 mg empty capsule shells contain ferric oxide black, and 150 mg empty capsule shells contain ferric oxide yellow. Capsules imprinting ink contains povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. In addition, red imprinting ink used in 37.5 mg and 75 mg capsules contain FD & C Red#40 aluminium lake. FDA approved dissolution test specifications differ from USP structure