Test results are provided for appearance, solubility, identification, appearance of solution, pH, related substances including specific impurities, loss on drying, heavy metals, sulphated ash, and assay. All test results comply with the specified British Pharmacopoeia monograph.
Test results are provided for appearance, solubility, identification, appearance of solution, pH, related substances including specific impurities, loss on drying, heavy metals, sulphated ash, and assay. All test results comply with the specified British Pharmacopoeia monograph.
Test results are provided for appearance, solubility, identification, appearance of solution, pH, related substances including specific impurities, loss on drying, heavy metals, sulphated ash, and assay. All test results comply with the specified British Pharmacopoeia monograph.
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Certificate of Analysis Consistent Quality
Product Name CLOMIPRAMINE HYDROCHLORIDE Analysis basis BP
Batch Number 20180111 Date of Mfg. 2018-01-11 Date of Expiry 2021-01-10 Quantity 25 kgs Packages Size 25kg/drum Keep the container tightly closed in a dry and well-ventilated indoor area, away Storage condition from light or heat or moisture ITEM SPECIFICATION RESULTS Appearance White or slight yellow, crystalline powder, White crystalline powder slightly hygroscopic Solubility Freely soluble in water and in methylene Conforms chloride, soluble in alcohol Identification A: Melting point: 191-195℃ 192-193℃ B: Infrared absorption spectrophotometry Conforms C,D,E: Conforms Conforms Appearance of solution Solution S is clear and not more intensely Conforms coloured than reference solution Y5 PH 3.5-5.0 4.1 Related substance Impurity B Not more than 1.0% 0.25% Impurity C Not more than 0.2% 0.1% Impurity D Not more than 0.2% 0.07% Impurity F Not more than 0.1% 0.07% Any other impurities Not more than 0.1% Conforms Total of other impurities Not more than 0.2% 0.12% Total of impurities Not more than 1.0% 0.61% Loss on drying Not more than 0.5% 0.3% Heavy metals Not more than 20ppm <20ppm Sulphated ash Not more than 0.1% 0.06% Assay 99.0-101.0% 99.5%