British Pharmacopoeia Volume III Formulated Preparations: Specific Monographs Cefradine Capsules General Notices Action and use Cephalosporin antibacterial. DEFINITION Cefradine Capsules contain Cefradine. The ply 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) to % 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 g of Cefradine with 25 mL of ammonia for 45 minutes and dilute 1 mL of the resulting solution to 10 mL with ammonia. (2) % w/v of cefradine BPCRS in 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%
