1.0 OBJECTIVE

1.1 To describe the procedure for preparation and standardization of volumetric solutions.

2.0 SCOPE

2.1 This SOP is applicable for preparation and standardization of volumetric solutions.

3.0 RESPONSIBILITY: Technical Manager/Quality Manager

4.0 PROCEDURE

4.1 Volumetric solutions should be prepared by accurately weighing a suitable quantity and dissolve it in freshly boiled and cooled water or other appropriate solvent to produce a specific volume as per the procedure.

4.2 Volumetric solutions shall be standardized by titration against a primary standard or by titration with a standard solution that has been recently standardized against a primary standard. Validity shall be depending on their validation studies.

4.3 Standardization shall be done in triplicate either manually or potentiometricaly as per pharmacopoeia or in-house requirements. Volumetric solution should not differ from the prescribed strength by more than 10 percent.

4.4 Re-standardization of volumetric solution performed periodically during use/Three times or If required.

4.5 All solutions that show evidence of deterioration, e.g. sedimentation, discoloration or crystallization, shall be discarded regardless of age.

4.6 All volumetric solution store in a glass bottles with stopper/cap with proper labeling.

4.7 Label indicates the following details as per SOP-

4.7.1 Name of the solution and strength

4.7.2 Identification Number of Volumetric Solution.

4.7.3 Actual Morality / Normality

4.7.4 Date of Preparation

4.7.5 Date of Standardization.

4.7.6 Date of Re-standardization

4.7.7 Use before

4.7.8 Signature of Prepared by.

4.7.9 Signature of standardized by.

4.7.10 Signature of Checked by

4.7.11 Signature of Re-standardized by/Date

4.8 Records shall be maintained for each solution or Details of standardization should be recorded in volumetric solution register by analytical chemist and checked by authorized person.. This record shall be retained for at least one year (Financial Year).

4.9        An identification number shall be allotted to each volumetric solution as follows: