| Preparation of volumetric solutions and standardization and determination of shelf-Life of volumetric solutions |
1.0 OBJECTIVE To lay down a procedure for the Preparation of volumetric solutions and standardization and determination of the shelf life of volumetric solutions in quality control department. 2.0 SCOPE This Procedure is applicable for the preparation of volumetric solutions, standardization and determination of the shelf-life of volumetric solution in quality control lab. 3.0 RESPONSIBILITY QC – Officer/ Sr. Officer /Executive/Sr. Executive and above. 4.0 ACCOUNTABILITY Head-QC 5.0 PROCEDURE 5.1 Preparation of volumetric solutions as mentioned in pharmacopoeia (IP, BP and USP) as applicable. 5.2 Unless otherwise specified in the individual monograph, to prepare ‘x’ molar of any volumetric solution by dissolving “x” multiplied by molecular weight in 1000 ml of purified water. 5.3 Unless otherwise specified in the individual monograph, to prepare ‘x’ normal of any volumetric solution by dissolving “x” multiplied by equivalent weight in 1000 ml of purified water. 5.4 All chemicals / solvents used for preparation of volumetric solution should be of AR grade. 5.5 Prepare the volumetric solution and standardize the solution as per individual monograph. 5.6 Standardization of Volumetric Solution: 5.6.1 Shelf Life 5.6.2 Initial Standardization of Volumetric Solution Shall be done on same day or next day and maintain record of preparation and standardization. 5.6.3 Standardization shall be done in initial, 1st day and 2nd day. 5.6.4 After that Standardization shall be done in three check point of 3 days, three check point of 7 days and 3 check point of 15 daysi.e.3rd,7th,15th,30th,35rd. 5.6.5 At each interval of Volumetric, solution shall not differ from prescribed strength by more than 10%, the Molarity shall be determined in triplicate, and RSD shall not be more than 0.2%. 5.6.6 Molarity/Normality at each interval should not be differ from more than 0.2% of the initial Molarity/Normality. 5.6.7 If the solution does not meet the criteria on 2ndday, then Shelf life shall be considered one day. 5.6.8 If the solution does not meet the criteria on 5th day than Shelf, life shall be considered 2 days. 5.6.9 Similarly, if the solution does not meet the criteria on 30th day then the shelf life shall be considered on 23rd days. 5.6.10 If the solution meets the criteria up to 37thdays, then the shelf life shall be assigned 30 days or one month. 5.6.11 Discontinue the shelf life study if any value does not meet the criteria. 5.6.12 Record the stability data and keep it documented in XXX. 5.6.13 Label the volumetric solutions with details as mentioned in format number XXX. 5.6.14 Assign reference number to each volumetric solution as follow and maintain the list as per format number XXX. VS-AA Where VS = volumetric solution AA =Serial Number of volumetric solution starting from 01. 5.6.15 Volumetric Solution Preparation & Standardization Record in XXX. 5.6.16 Note: Shelf-life of any volumetric solutions should be as per individual monograph if specified. 5.6.17 For e.g.: Sodium Thiosulphate: The same should be prepared and standardized weekly. Conduct stability of volumetric solutions as per the above plan and record the same preparation in format number QC01-002/F03. 5.6.18 Storage of Volumetric solution 5.6.18.1 Store all the volumetric solutions in cleaned dry glass bottles. Stored light sensitive solutions in amber colour glass bottles for no degradation. 5.6.18.2 Volumetric solution must not be preserve for more than one month. 5.6.18.3 If during usage any change in physical properties of the solution observed, then discard the same. 5.6.18.4 Store all volumetric solution at room temperature. 5.6.18.5 Precautions: The volumetric solutions should never be used if any fungal growth or precipitation. is observed. Before using any volumetric solution, shake the solution well in order to mix the drops of water condensed on the top and sides of the bottles with the solutions in the bottle. Always pour the content opposite to the label on the bottle to avoid spoiling of label if spoiled change the same. Dispense the minimum required quantity of volumetric solutions for analysis from bottle of volumetric solutions in a beaker. Discard the balance quantity in the beaker after completion of analysis. |