Method of Analysis for Sodium Chloride Injection IP (0.9% w/v) |
1.0 PROCEDURE 1.1 Sampling and Handling of Sodium Chloride Injection 1.1.1 Quantity of Composite Sample for Analysis 100 ml in well closed container 1.1.2 Quantity of Reserve Sample 100 ml in well closed container. 1.1.3 Label Claim of Sodium Chloride Injection Each 100ml contains: Sodium Chloride IP/BP/USP………0.9% w/v Water for Injections IP/BP/USP……..q.s. To read this method of analysis click here Method of analysis for Hydrochloric Acid IP. 1.2 Test and Method 1.2.1 Description: A clear colourless solution. 1.2.2 pH Measure the pH value of the undiluted solution, at 25 degree Celsius on suitable calibrated pH meter. Limit: 4.5 to 7.0 To read this method of analysis click here Method of analysis for Lactic Acid IP. 1.2.3 Assay: Transfer 10.0 ml of Injection to 250 ml conical flask, dilute with distilled water to about 150 ml, add 1.5 ml of Potassium Chromate solution, and titrate with 0.1M Silver Nitrate. Each ml of 0.1M silver nitrate is equivalent to 0.005844g of NaCl. Calculate the contents of sodium chloride in % w/v by the following expression: Burette reading X Molarity of 0.1M AgNO3 X 0.005844 X 100 / 10.0 X 0.1 = ………%w/v % Assay of sodium chloride = ………%w/v / 0.9 X 100 |