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SOP for Shelf life of Volumetric Solutions

OBJECTIVE
To validate and ascertain the shelf life of volumetric solutions.

SCOPE
This procedure is applicable for ascertaining the shelf life of volumetric solutions prepared in the Quality control department.

RESPONSIBILITY
Quality Control Chemist and above
Quality Control Head

PROCEDURE
  • The solution prepared for chemical analysis is not stable for a longer period. Incorrect strength/ concentration can affect the result of analyzed products.
  • The shelf life of the solution depends on the nature of the chemical, solvent, and temperature of storage.
  • Therefore it is necessary to validate the stability period individually.
  • Prepare and standardize the volumetric solutions as per SOP for Preparation, Standardization &  Storage of Volumetric Solutions
  • Ascertain shelf life of volumetric solution by visual inspection for precipitation and turbidity.
  • Record the observation daily in Annexure No.: 01.
  • Ascertain the shelf life of the volumetric solution by standardization the solution 6 times at an interval of one week starting from the date of preparation.
  • Frequency of Standardisation:
  1. First Standardisation: Date of Preparation.
  2. Second Standardisation: On 07 days + 1 day.
  3. Third Standardisation: On 14 days + 1 day.
  4. Fourth Standardisation: On 21 days + 1 day.
  5. Fifth Standardisation: On 28 days + 1 day.
  6. Sixth Standardisation: On 35 days + 1 day.
  • Perform the standardization twice each time and take a mean.
  • Record the observation in Annexure No.: 02.
  • Deviation for standardization values shall not be more than 1.0 % from the initial result.
  • Assign shelf life after completion of validation.

ABBREVIATIONS
% : Percentage
SOP : Standard Operating Procedure

ANNEXURES
Annexure No. 01 - Format for ascertaining shelf life of volumetric solutions by visual inspection.
Annexure No. 02 - Format for ascertaining shelf life of volumetric solutions by standardization.


REVISION HISTORY
Nil

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