Comply with the requirement of tests stated under Tablets. Assay Weigh and powder 20 tablets Weigh accurately a quantity of me powder equivalent to about 60 mg of Carbamazepine and boil in a flask with 25 ml of ethanoi (96%) for a lew minutes, stir the hot mixture in the dosed flask for 10 minutes and filter through a sintered-glass funnel, washing the flask and funnel with ethanoi (95%) and adding sufficient ethanoi (95%) To the cooled filtrate To produce 100.0 ml. Dilute 5.0 ml to 250.0 ml with ethanoi (9S%) and measure the absorbance of the resulting solution at the maximum at about 285 run, Appendx 55 Calculate the content of C15 H12 N2 O taking 490 as the value of A(1%, 1 cm) at the maximum at about 286 runCARBENlCILLlN SODIUM Carbenicillin DisooiumC17H16N2Na206S Mol Wl 42236 Carbenicillin Sodium is the disodium (6R)-6-[(2RS)-2 carboxylato-2-phenylacetarndo ] penicillinate Category. Antibacterial Dose By Intravenous injection, the equivalent of 12 to 30 got carbenicillin dally, in divided doses, by intramuscular Injection, the equivalent of 4 to 8 g of carbenicillin daily, in divided doses Description While or slightly yellowish powder, odourless, hygroscopic Solubility Freely soluble in water, soluble in ethanoi (95%), practically insoluble in chloroform and in ether Storage Store In sterile containers, sealed so as to exclude micro-organisms, in a cold place. STANDARDSCarbenicillin Sodium contains the equivalent of not less than 770 ug of carbenicillin per mg. calculated with reference to the anhydrous substance Identification A The infrared absorption spectrum. Appends 54, is concordant with the reference spectrum of carbeniciilin sodum 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 Ireshly 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 decolourteed within 2 minutes C A 5% w/v solution gives the reactions of sudium salts, Appendx 3.1 pH. Between 6.5 and 80. determined in a 10% w/v solution. Appends 8.11 Specific optical rotation: Between +182° and +196* determined at 20* in a 1 % w/v solution, Appendx B 9 lodine-absortlng 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 70 to produce 25.0 ml. To 10.0ml add 10 ml of mixed phosphate buffer pH 40 and 10.0ml of OOIM iodine and titrate immediately with 0 01M sodium thiosulphate using starch solution, added towards the end of the tilration. as indicator Repeat the operation without the substance being examined The difference between the titratlon represents the amount of iodine-absorbing substances present Each ml of 0 01M aodum thiosufphae Is equivalent to 0.000439 g of iodine-absorbing substances Water. Not more than 6.0% w/w, determined on 0.15 g. Appendix 324Pyrogens Complies with the lest for pyrogens, Appendx 2 6. using 6 mg per kg of the rabbit's weight dissolved in 1 ml of water for Injection Assay Cany out the microbiological assay of antibiotics. Method A. Appendix 9 1, and express the result in μg
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