STABILITY OF VOLUMETRIC SOLUTIONS

OBJECTIVE 

To lay down a procedure for Evaluation of Stability of standardized Volumetric Solution and to confirm the Expiry period of the Volumetric Solution. 

2.0      SCOPE

This SOP shall be applicable for the identifying stability and use before period of standardized volumetric solution prepared in QC department.

3.0       RESPONSIBILITY

3.1       Preparation & Execution – Executive and above-QC Department

3.2       Approval   – Asst. Manager and above-QC Department

4.0       ACCOUNTABILITY

Head of the QC Department  

      5.0      PROCEDURE

      5.1      Prepare and standardize the volumetric solutions as per their respective Standard test procedure.

      5.2      Stability Study of Volumetric Solution shall be carried out on standardized Volumetric Solution. 

      5.3      Executive and above shall perform the stability studies for Volumetric Solutions.

      5.4      Standardization Frequency: Initial, 15 days, 30 days, 40 days and 45 days of preparation.

      5.5      The Volumetric Solution is considered to be stable till the RSD of Normality / Molarity is with in 0.5% of the initial value and no turbidity or any sedimentation

                   appears in the solution.

     5.6      Standardization shall be performed in three sets at each step.

     5.7       With the help of collective data, Expiry Date / Use Before Date of the volumetric Solution shall be assigned.

     5.8       Quality Control Department shall prepare respective Protocol for stability of volumetric solution. 

     5.9      This Protocol shall be prepared on the approved format on A-4 size paper as per Annexure-I with the font Type Times New Roman, and font size as below:

   5.10        All the Protocols shall be written in clear, unambiguous language, easy to understand and easy to use

  5.11      Describe the table of contents and its details stepwise.

  5.12       Each protocol shall have unique number. Once a number is allocated to any Protocol, the same number shall not be repeated to other Protocol. 

   5.13       Protocol No. shall be alphanumeric identification no. having 10 characters which are as follows.

  Where:- 

V = Volumetric

S = Solution

P = Protocol

/ = Separator

   XXX     = Corresponds to Sr. number starting from 001 continuously to have details of total Volumetric Solutions in Quality Control laboratory.

    YY        =          Corresponds to the last two digit of year in which Volumetric Solution is prepared.  

    For example: VSP/25/001

5.14     After initiation, approval and authorization of protocol, the master copy shall be submitted to QA documentation cell.

5.15       QA department shall issue a photocopy.

5.16       QC shall use a photocopy of operational copy.

   5.17     Section In-charge shall issue the photocopy for use purpose.

   5.18   Maintain the issuance record of volumetric solution stability protocol.

   5.19 Any change in Protocol shall be done through change control procedure .

About the Author

Author

Administrator

"A seasoned professional with a Master's in Chemistry, the author brings more than two decades of expertise in Quality Control, Analytical Method Validation, and advanced QMS investigation. Their experience is globally validated by successful management of major regulatory audits, including those conducted by the US, EU, Brazil, and Russian authorities."

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