Appendix 2 B. using per kg of the rabbit's weight 1 ml of a solution containing 1 5 mg per ml of the substance

2 B. using per kg of the rabbit's weight 1 ml of a solution containing 1 5 mg per ml of the substance being examined in water for injection.Stenlity: Complies with the tests for sterility. Appendix 95 BENZVLPENICILLIN SODIUM Penicillin G SodiumC1GH17Na04S Mol Wi 356 37 Benzylpenicillin Sodium is sodium (6R)-6-(2- phenylacetamido) penicillanate, produced by the growth of certain strains of Penicillium notatum or related organisms, or obtained by any other means Category: Antibacterial Dose By intramuscular or by slow intravenous injection or by infusion, the equivalent of 1 2 to 2.4 g of benzylpenicillin daily, in 4 divided doses Description White or almost white, crystalline powder Solubility Very soluble in water. practically insoluble in chloroform, m ether, in fixed oils and in liquid paraffin BStorage Store in lightly-closed containers in a cool, dry place If it is intended for use in the manufacture of injectabJe preparations. the container should be sterile and sealed so as to exclude micro-organisms Labelling The Label stales whether or not the contents are intended for use in the manufacture of injectable preparations STANDARDSBenzy(penicillin Sodium contains not less than 96.0 per cent and not more than 100.5 per cent of penicillins, calculated as C16 H17 N2 O4 S with reference to the dried substance. Identification. Test A may be omitted if tests B and C are earned out Test B may be omitted if tests A and C are carried out A The infra-red absorption spectrum, Appendix 5 4. is concordant with the spectrum obtained from benzylpenicillin sodium RS.B Gives the reactions of penicillins and cephalosponns. Appendix 3 1 C: Gives reaction A of sodium sails. Appendix 3 1.pH, Loss on drying Complies with the requirements stated under Benzylpenicillin Potassium Light absorption Carry out the test described under Benzylpemcillin Potassium using 90 mg of the substance berng examined Specific optical rotation: Between +265° and +310°. determined in a 2%n w/v solution in carbon dioxide FREE water. Appendix B.9 Assay Weigh accurately about 50 mg and carry out the Assay