Clomipramine hydrochloride CAS NO.17321-77-6

1) Description A White or slightly yellow, crystalline powder; slightly hygroscopic. 2) Solubility Freely soluble in water and in methylene chloride, soluble in alcohol, practically insoluble in eth…

1) Description A White or slightly yellow, crystalline powder; slightly hygroscopic. 2) Solubility Freely soluble in water and in methylene chloride, soluble in alcohol, practically insoluble in ether. 3) Identification Examine by infrared absorption spectrophotometry, comparing with the spectrum obtained with clomipramine hydrochloride CRS. Examine the substances as discs prepared using potassium chloride R. Dissolve about 50 mg in 5 ml of water R and at 1 ml of dilute ammonia R1. Mix, allow to stand for 5 min & filter. Acidify the filtrate with dilute nitric acid R. The solution gives reaction (a) of chlorides. 4) Appearance of solution A 10% solution in carbon dioxide free water R is clear and not more intensely coloured than reference solution Y5. 6) Related Substances (by TLC) I. Imipramine hydrochloride --- NMT 1% II. Other by-products --- NMT 0.2% 7) Heavy Metals NMT 20 ppm 8) Loss on drying NMT 0.5% 9) Sulphated ash NMT 0.1% 10) Assay 99% - 101%