To describe the procedure for preparation and standardization of volumetric solutions.
This SOP is applicable for preparation and standardization of volumetric solutions.
Officer/ Executive - Quality Control.
Manager – Quality Control.
5.1 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.
5.2 Solutions of primary standard or highly purified salts that are of primary standard quality do not require standardization initially. Standard solutions may be prepared by accurately weighing a suitable quantity and dissolving it to produce a specific volume.
5.3 Standard solutions prepared by exact dilution of a stronger standardized solution, do not require initial standardization but must be re-standardized periodically during use.
5.4 Solutions that are not used frequently or whose strength changes by more than 1% in a week must be standardized on the day of use. Solutions that are in routine use shall be standardized at intervals determined by their stability.
5.5 Solutions of limited stability should be prepared on the day of use and discarded on completion of analysis.
5.6 All solutions that show evidence of deterioration, e.g. sedimentation, discoloration or crystallization, shall be discarded regardless of age.
5.7 Dilute solution that are subject to change, e.g. 0.1 N Potassium Permanganate or 0.1N Sodium Thiosulfate should be prepared on the day of use by exact dilution of standard solution with recently boiled and cooled water.
5.8 All bottles shall be labeled indicating the name and the strength of the solution, date prepared, signature of the person who prepared it and use before date.
5.9 Records shall be maintained for each solution starting with the value determined when the solution was prepared and continuing with the values determined throughout the shelf life of the solutions. This record shall be retained for at least one year after the solution is expended.
5.10 Volumetric solutions should be prepared and standardized as per procedure in the individual monograph and the containers have to be labeled with following details as per SOP.
5.10.1 Name of the solution and strength.
5.10.2 Reference No.
5.10.3 Morality / Normality
5.10.4 Date of Preparation
5.10.5 Date of Standardization.
5.10.6 Date of Re-standardization
5.10.7 Use before
5.10.8 Signature of Prepared by.
5.10.9 Signature of Checked by
5.11 Details of standardization should be recorded in volumetric register by analytical chemist in standardization note book and checked by QC Officer.
5.12 All volumetric solutions should be restandardized with in fifteen days or re-standardize before use if not standardized with in fifteen days.
5.13 Batch numbering of volumetric solutions:
A batch number shall be allotted to each volumetric solution as follows:
VS01 – 1/1
VS01 is the volumetric solution number.
-1 is the number of times solution prepared
/1 is the number of times solution standardized.
6.1 SOP - Standard Operating Procedure
6.2 N - Normal
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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