The label states the quantity of Carbenicillin Sodium contained in the sealed container

containers, sealed so as to exclude micro-organisms, in a cold place STANDARDS Carbenicillin Sodium contains the equivalent of not less than 770 µg of carbenicillin per mg, calculated with reference to the anhydrous substance Identification: A: The infra-red absorption spectrum, Appendix 5.4, is concordant with the reference spectrum of carbenicillin sodium or with the spectrum obtained from carbenicillin sodium RS. B: Heat 0.5 g in a small sealed container on a water- bath for 3 minutes, remove the seal, and immediately replace by a cork fitted with a platinum loop carrying a drop -of a solution freshly prepared by mixing 1 ml of a 0 5% w/v solution of sodium carbonate, 1 ml of phenolphthalein solution and 10 ml of water, the reagent is decolourised within 2 minutes. C: A 5% w/v solution gives the reactions of sodium salts, Appendix 3.1. pH: Between 6.5 and 8.0, determined in a 10% w/v solution, Appendix 8.11. Specific optical rotation: Between +182° and +196°, determined at 20° in a 1 % w/v solution, Appendix 8.9. Iodine-absorbing substances: Not more than 80%, calculated with reference to the anhydrous substance, determined by the following method Weigh accurately about 0.13 g and dissolve in sufficient mixed phosphate buffer pH 7.0 to produce 25.0 ml. To 10 0 ml add 10 ml of mixed phosphate buffer pH 4.0 and 100 ml of 0.01M iodine and titrate immediately with 0.01M sodium thiosulphate using starch solution, added towards the end of the titration, as indicator. Repeat the operation without the substance being examined. The difference between the titration represents the amount of iodine-absorbing substances present. Each ml of 001M sodium thiosulphate is equivalent to 0000489 g of iodine-absorbing substances. Water: Not more than G 0% w/w, determined on 0.15 g, Appendix 3.24. Pyrogens: Complies with the test for pyrogens, Appendix 2.6, using 6 mg per kg of the rabbit's weight dissolved in 1 ml of water for injection. Assay: Carry out the microbiological assay of antibiotics, Method A, Appendix 9.1, and express the result in µg of carbenicillin per mg. CARBENICILLIN SODIUM INJECTION Carbenicillin Injection; Carbenicillin Disodium InjectionCarbenicillin Sodium Injection is a sterile solution of Carbenicillin Sodium, with or without auxilliary substances, in Water for Injection. It is prepared by dissolving the contents of a sealed container in the requisite amount of Water for Injection immediately before use. Usual strengths The equivalent of 1 g and 5 g of carbenicillin. Storage: Store in sealed containers in a cold place. The constituted solution should be used within 24 hours after preparation and stored strictly in accordance with the manufacturer's instructions. Labelling: The label states the quantity of Carbenicillin Sodium contained in the sealed container in terms of the equivalent amount of carbenicillin. STANDARDSCarbenicillin Sodium Injection contains the equivalent of not less than 90.0 per cent and not more than 110.0 per cent of carbenicillin, C17H18N2O6S. 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 powder, odourless; hygroscopic Identification;. pH; Specific optical rotation; lodineabsorbing substances; Water: Pyrogens: Comply with the requirements stated under Carbenicillin Sodium. Assay: Carry out the Assay