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2.Cardiovascular Agents: 2.1.SimvastatinDMF Available Standard: USP 28, EP 5 Description: a white crystalline powder Identification: IR, UV: positive Clarity of solution: the solution is clear Color of solution: no more intensely colored than BY7 Specific rotation: +285 ~ +300o Loss on drying: ≤0.5% Residue on ignition: ≤0.1% Heavy metals: ≤20ppm Related substances: Simvacid: ≤0.4% Simvavastate: ≤0.4% Simvaen: ≤0.4% Dimer: ≤0.4% Lovastatin: ≤1.0% Total impurities: ≤1.0% Assay (on dry basis): 97.0 - 102.0% 2.2.Pravastatin SodiumDMF Available Standard: EP 5 White to yellowish powder or crystalline powder Impurity A: 0.3% Max Unidentified individual impurity: 0.2% Max Total impurities: 0.6% Max Residual solvents: Acetone: 5000ppm Max Butyl Acetate: 5000ppm Max Ethyl Acetate: 5000ppm Max Identification: IR spectrum conforms to reference standard Positive for sodium Specific rotation: +153° - +159° Appearance of solution: Clear, Color≤BY6 pH: 7.2 - 9.0 Water: 4.0% Max Heavy metals: 20 ppm Max Assay (On dry basis): 97.0 - 102.0% 2.3.Betaxolol HCLBetaxolol HCL and Intermediates Betaxolol Intermediate-1: 1-[4-(2-hydroxyethyl) phenoxy]-2, 3-poxypropane Betaxolol Intermediate-2: 1-{(4-[2-(cyclopropylmethoxy)-ethyl]-phenoxy)-2, 3-epoxypropane Betaxolol Intermediate-3: Betaxolol Base 1-[4-(2-CYCLOPROPYLMETHOXY-ETHYL)-PHENOXY]-3-[(1-METHYLETHYL)AMINO]-2-PROPANOL Betaxolol HCl Betaxolol SULPHATE 2.4.Atorvastatin CalciumStandard: Enterprise standard Assay: 98% Min Characteristics: a white or almost white crystalline powder Specific rotation: -7.0 ~ -9.0 Water: 3.5% ~ 5.5% Calcium: 3.0% ~ 3.6% Heavy metals: ≤10ppm Impurity (HPLC): Atorvastatin Lactone: ≤0.3% Desfluoro-atorvastatin calcium: ≤0.2% Diamine-atorvastatin calcium: ≤0.3% Isomer-atorvastatin calcium: ≤0.2% Other individual: Unknown impurity: ≤0.15% Total impurity: ≤1.0% Assay: 98.0 - 102.0% 2.5.Rosuvastatin CalciumCharacter: a white or almost white powder Identification: positive reaction Specific optical rotation: +14 ~ +22o pH: 5.6 - 7.2 Related impurities: Total impurity: ≤1.0% Individual impurity: ≤0.5% Loss on drying: ≤5.0% Ca: 3.5 - 4.5% Heavy metals (ug/g): ≤20 Assay (on unhydrous basis): ≥98.5% 2.6.Pitavastatin CalciumCharacter: a white or almost white powder Identification: positive reaction Specific optical rotation: +14 ~ +22o pH: 5.6 - 7.2 Related impurities: Total impurity: ≤1.0% Individual impurity: ≤0.2% Loss on drying: ≤5.0% Ca: 3.5 - 4.5% Heavy metals (ug/g): ≤20 Assay (on unhydrous basis): ≥98.5% 2.7.IndapamideStandard: USP29; DMF Available Appearance: white or off white crystalline powder Melting point: 162 ~ 167oC Loss on drying: 2.4% max. Related substances: 1.0% max. Heavy metals: 10ppm max. Residue on ignition: 0.1% max. Assay: 98.0~101.0% 2.8.Enalapril Maleate Quality standard : USP; DMF Available Appearance: White or off-white crystalline powder
