Method of analysis of Disodium Edetate IP (EDTA) |
1.0 PROCEDURE 1.1 Sampling and Handling 1.1.1 Quantity for composite sample for analysis Disodium Edetate IP Molecular weight : 372.2 1.1.2 Control sample: For chemical analysis: 2 x20gm 1.2 Physical and Chemical Testing 1.2.1 Description White crystalline powder. odourless. Spread about 2.0 gram of sample in a clean dry petri dish and observed with unaided eye and observed. 1.2.2 pH Between 4.0 and 5.5, determined in a 5% w/v solution, Measure the pH value of the liquid, at 250C on Suitable calibrated pH meter. 1.2.3 Iron 20 ml of a 2.5% w/v solution complies with the limit test for iron, (80 ppm). Add 0.25 g of calcium chloride to each soln. before adding mercaptoacetic acid.. Add 2 ml of 20 % w/v solution of iron-free citric acid and 0.1 ml of thioglycollic acid,mix make alkaline with iron-free ammonia solution, dilute to 50.0 millilitre with water and allow to stand for 5 minutes. Any colour produced is not more intense than that obtained by treating in the same manner 2.0 ml of iron standard solution (20 ppm Fe) in place of the solution being examined. After 5 min, any pink colour in the test solution is not more intense than that in the standard. To read this GTP click here Method of analysis of Sodium Hydroxide. 1.2.4 Assay Take 0.5 g or 500mg, dissolve in sufficient water to produce 300 ml and add 2 g of hexamine and 2 ml of 2M hydrochloric acid. Titrate with 0.1Mol lead nitrate using about 50.0 milligram of xylenol orange triturate as indicator. Each ml of 0.1M lead nitrate is equivalent to 0.03722 g of C10H14N2Na2O8,2H2O. Calculation : % Assay = BR. X Molarity of lead nitrate X 0.03722 x 100 / Weigh of sample x 0.1 Where – BR.= volume in 0.1M lead nitrate consumed in the titration. |