Shelf life of Volumetric Solutions – SOP

SOP for Shelf life Study of Volumetric Solutions | Volumetric Solution Stability Study SOP |

• Shelf life of volumetric solutions SOP covers below points:
  • Shelf life Study of Volumetric Solutions procedure
  • Frequency of Standardisation
  • Shelf life Study format

1.0 OBJECTIVE :

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

2.0 SCOPE :

• This procedure is applicable for ascertaining shelf life of volumetric solutions prepared in Quality Control Department.

3.0 RESPONSIBILITY :

• Quality Control Chemist and above

4.0 ACCOUNTABILITY:

• Quality Control Head

5.0 PROCEDURE :

Solution prepared for chemical analysis is not stable for longer period. Incorrect strength/  concentration can affect the result of analysed products.

Shelf life of solution depends on nature of chemical, solvent and temperature of storage.

Therefore it is necessary to validate the stability period individually.

5.1 Prepare and standardise the volumetric solutions as per SOP of Preparation, Standardisation and Storage of Laboratory Solutions

5.2 Ascertain shelf life of volumetric solution by visual inspection for precipitation and turbidity.

5.3 Record the observation daily in Annexure No.: 01.

5.4 Ascertain shelf life of the volumetric solution by standardisation of the solution 6 times at an interval of one week starting from the date of preparation.

• Frequency of Standardisation:
  • First Standardisation                : Date of Preparation.
  • Second Standardisation           : On 07^th day + 1 day.
  • Third Standardisation : On 14^th day + 1 day.
  • Fourth Standardisation             : On 21^st day + 1 day.
  • Fifth Standardisation                : On 28^th day + 1 day.
  • Sixth Standardisation               : On 35^th day + 1 day.

5.5 Perform the standardisation twice for each time and take a mean.

5.6 Record the observation in Annexure No.: 02.

5.7 Deviation for standardisation values shall not be more than 1.0 % from the initial result.

5.8 Assign shelf life after completion of validation.

 6.0 ABBREVIATIONS:

Abbreviation	Expanded form
%	Percentage
SOP	Standard Operating Procedure

7.0 ANNEXURES:

Annexure No.	Title
01	Format for ascertaining shelf life of volumetric solutions by visual inspection
02	Format for ascertaining shelf life of volumetric solutions by standardisation

8.0 SOP REFERENCES

• GLP Guidelines

END OF THE SOP

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ANNEXURES :

Annex. No. 01 Format for ascertaining shelf life of volumetric solutions by visual inspection

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Annex. No. 01 Format for ascertaining shelf life of volumetric solutions by standardisation

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