头孢拉定胶囊英国药典BP2013 UpdatedB.doc

British Pharmacopoeia Volume III Formulated Preparations: Specific Monographs Cefradine Capsules General Notices Action and use Cephalosporin antibacterial. Definition Cefradine Capsules contain Cefradine. The capsules comply with the requirements stated under Capsules and with the following requirements. Content of cephalosporins, calculated as the sum of cefradine (C16H19N3O4S), cefalexin (C16H17N3O4S) and 4′,5′-dihydrocefradine (C16H21N3O4S) 90.0?to 105.0% of the stated amount of Cefradine. Identification A. The infrared absorption spectrum of the contents of the capsules, Appendix II A, is concordant with the reference spectrum of cefradine (RS 050). If the spectra are not concordant, dissolve a quantity of the capsule contents containing 30?mg of Cefradine in 10?mL of methanol, evaporate to dryness at 40° at a pressure of 2?kPa and prepare a new spectrum. B. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions. (1) Shake a quantity of the contents of the capsules containing 0.1?g of Cefradine with 25?mL of 0.01m ammonia for 45?minutes and dilute 1?mL of the resulting solution to 10?mL with 0.01m ammonia. (2) 0.040% w/v of cefradine BPCRS in 0.01m ammonia. chromatographic conditions (a) Use a TLC silica gel plate (Analtech plates are suitable). Impregnate the plate by placing it in a tank containing a shallow layer of a 5% v/v solution of n-tetradecane in n-hexane, allowing the impregnating solvent to ascend to the top, removing the plate from the tank and allowing the solvent to evaporate; use with the flow of the mobile phase in the same direction that the impregnation was carried out. (b) Use the mobile phase as described below. (c) Apply 5?μL of each solution. (d) Develop the plate to 15 cm. (e) After removal of the plate, heat at 90° for 2?to 3?minutes and spray the hot plate with a 0.1% w/v solution of ninhydrin in the mobile phase. Heat at 90° for 15?minutes in a circulating air oven with the plates paralle