头孢拉定胶囊英国药典BP2009Updated.pdf

Browse: British Pharmacopoeia 2009 British Pharmacopoeia Volume III Formulated Preparations: Specific Monographs Cefradine Capsules 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, (C H N O S) and 16 19 3 4 cefalexin (C H N O S) 16 17 3 4 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 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 a silica gel G precoated plate (Analtech plates are suitable) and the mobile phase and method of visualisation described under Related substances. Impregnate the plate as described under Related substances and apply separately 5 µl of each of the following solutions. For solution (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. Solution (2) contains 0.040% w/v of cefradine BPCRS in 0.01 M ammonia. The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2). TESTS Dissolution Comply with the requirements for Monographs of the British Pharmacopoeia in the dis