Clindamycin-Phosphate.pdfVIP

Browse: British Pharmacopoeia 2009 British Pharmacopoeia Volume I II Monographs: Medicinal and Pharmaceutical Substances Clindamycin Phosphate Clindamycin Phosphate General Notices (Ph Eur monograph 0996) C18H34ClN2O8PS

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24729-96-2 Action and use Lincosamide antibacterial. Preparation Clindamycin Injection Ph Eur DEFINITION Methyl 7-chloro-6,7,8-trideoxy-6-[[[(2S,4R)-1-methyl-4-propylpyrrolidin-2-yl]carbonyl]amino]-1- thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). Semi-synthetic product derived from a fermentation product. Content 95.0 per cent to 102.0 per cent (anhydrous substance). CHARACTERS Appearance White or almost white, slightly hygroscopic powder. Solubility Freely soluble in water, very slightly soluble in ethanol (96 per cent), practically insoluble in ?Crown Copyright 2006 1 Freely soluble in water, very slightly soluble in ethanol (96 per cent), practically insoluble in methylene chloride. It shows polymorphism (5.9). IDENTIFICATION First identification
A, D. Second identification
B, C, D.
A. Infrared absorption spectrophotometry (2.2.24). Preparation
Discs of potassium bromide R. In 2 separate tubes place 50 mg of the substance to be examined and 50 mg of clindamycin phosphate CRS. Add 0.2 ml of water R and heat until completely dissolved. Evaporate to dryness under reduced pressure and dry the residues at 100-105 °C for 2 h. Comparison
clindamycin phosphate CRS.
B. Thin-layer chromatography (2.2.27). Test solution
Dissolve 20 mg of the substance to be examined in methanol R and dilute to 10 ml with the same solvent. Reference solution (a)
Dissolve 20 mg of clindamycin phosphate CRS in methanol R and dilute to 10 ml with the same solvent. Reference solution (b)
Dissolve 10 mg of lincomycin hydrochloride CRS in 5 ml of reference solution (a). Plate
TLC silica gel plate R. Mobile phase
glacial acetic acid R, water R, butan