SOP for Preparation of Stock Solution for Limit Test : Pharmaceutical Guidelines

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SOP for Preparation of Stock Solution for Limit Test

Standard operating procedure to prepare the stock solution for determination of limit tests.

1.0 OBJECTIVE

To lay down the procedure for preparation of the stock solution for the limit test.

2.0 SCOPE

This SOP shall be applicable to Quality Control Dept.

3.0 RESPONSIBILITY

Supervisor Quality Control.

4.0 ACCOUNTABILITY

Sr. Quality Assurance Manager

5.0 PROCEDURE

5.1 The date of preparation of the solution, quantity prepared and the signature of the Quality Control Supervisor should be entered in the record.
5.2 The limit test solutions shall be prepared as per the procedure laid down in the Appendix of the Indian Pharmacopoeia-2010.
5.3 The solutions shall be replaced after a period of three months.
5.4 The label shall bear the name of the solution, strength, date of preparation, the date before which it is to be used and the name and initials of the person who prepares the solution.
5.5 The solutions shall be stored in suitable glass stoppered bottles as specified in the Indian Pharmacopoeia.
Related: Determination of Shelf Life of Solutions in Laboratory

6.0 ABBREVIATION

6.1 SOP : Standard Operating Procedure
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