Sunday, August 2, 2009

and add sufficient water to produce 10.0.0 ml. Place two quantities, each of 2 ml, of the solution in separate stoppered tubes.

degradation products from the calculated percentage content of total penicillins to calculate the percentage content of amoxycillm sodium. Amoxycilln Sodium intended for use in the manufacture of injectable preparations complies with the following additional requirements. Pyrogens: Complies with the test for pyrogens, Appendix 2.6, using 1 ml of a solution in water for injection containing 20 mg per ml per kg of the rabbit's weight. Sterility: Complies with the tests for sterility, Appendix 9.5 AMOXYCILLIN SODIUM INJECTION Amoxycillin Injection; Amoxicilln Sodium Injection; Amoxicillin Injection Amoxycillin Sodium Injection is a sterile solution of Amoxycillin Sodium in Water for Injection. It is prepared by dissolving the contents of a sealed container in the requisite amount of Water for Injectionimmediately before use. Usual strengths: The equivalent of 100 mg, 250 mg, 500 mg and 1 g of amoxycillin. Storage: Store m a cool, dry place. The reconstituted solution should be used immediately after preparation. Labelling: The label states the quantity of Amoxycillin Sodium contained in the sealed container in terms of the equivalent amount of amoxycillm. STANDARDSAmoxycillin Sodium Injection contains not less than 90.0 per cent and not more than 120.0 per cent of the stated amount of amoxycillin, C16H19N3O5S. The injection complies with the requirements of tests stated under Injectable Preparations (Powders for Injection). The contents of the sealed container comply with the following requirements. Description: White or almost white amorphous powder, very hygroscopic. Identification; pH; Clarity and colour of solution; Specific optical rotation; NN-Dimethylanilne, Degradation products; Water;Pyrogens; Sterility: Comply with the requirements stated under Amoxycillin Sodium. Assay: Determine the weight of the contents of 10 containers. Dissolve 0.17 g of the mixed contents of the 10 containers in sufficient water to\ produce 500.0 ml. Transfer 10.0 ml of the resulting solution to a 100-m1 volumetric flask, add 10 ml of alkaline borate buffer pH 9.0 followed by I ml of acetic anhydnde-dioxan solution, allow to stand for 5 minutes and add sufficient water to produce 10.0.0 ml. Place two quantities, each of 2 ml, of the solution in separate stoppered tubes. To one tube add 10 ml of imidazole-mercury reagent, stopper the tube and place in a water-bath at 60° for

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