Sunday, August 2, 2009

Appendix 8 G Assay Weigh accurately about 50 mg. dissolve in 5 ml of water

determined on 1 g by drying m an oven at 105°. Appendix 8 G Assay Weigh accurately about 50 mg. dissolve in 5 ml of water, add 5 ml of 1 M sodium hydroxide and allow to stand for 15 minutes Add 5 ml of 1 M nitric acid, 20 ml of acetale buffer pH 4 6 and 20 ml of water and titrate at 35° to 4O ° with 0.02M mercuric nitrate Titrate slowly so thai the titraticn takes about 15 minutes Determine the end-point potentiornetrically using a platinum or mercury indicator electrode and a rnercury-mercurous sulphate reference electrode (Cleaning the reference electrode with dilute mine acid and the indicator electrode with a 10% w/v solution of sodium thiosulphate followed by rinsing with distilled water is recommended after each assay) Ignore any preliminary inflection on the litration curve. Each ml of Q02M mercuric nitrate is equivalent to O.007450 g of total penicillins, calculated as C16 H17 KN2 O4 S. To 0.25 g. accurately weighed, add 25 ml of water and 25 ml of acelale buffer pH A 6 and shake until solution is complete Titrate immediately at room temperature with 0.02M mercuric nitrate determining the end-point as above Each nil of 0 02M mercuric nitrate is equivalent to 0.007450 g of degradation products, calculated as C16 H17 KN2 O4 S..Calculate the percentage content of total penicillins and the percentage content of degradation products. The difference between the two percentages is the content of penicillins Benz ylhenicillin Potassium intended for use in the manufacture of inject able preparations complies with the following additional requirement Pyrogens Complies with the test for pyrogens.

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