SOP for Preparation of Volumetric Solutions : Pharmaceutical Guidelines

SOP for Preparation of Volumetric Solutions

Standard operating procedure to prepare and standardize the Volumetric Solutions.

1.0 OBJECTIVE

To lay down a procedure for preparation, identification & information of the volumetric solutions which are in use for analysis.

2.0 SCOPE

This procedure is applicable for all volumetric solutions, which are to be used during analysis .

3.0 RESPONSIBILITY

3.1 Doing : Technical Assistant /Executive
3.2 Checking : Executive/Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Select the chemicals to be used for the preparation of volumetric solutions which has remaining shelf life of not less than 2 years counting from the date of opening of the chemical bottle.
5.2 Use A.R./Merck certified grade chemicals for the preparation and standardization of volumetric solutions.
5.3 Refer the file having authorised method for preparation and standardization of volumetric solutions.
5.4 Prepare all the volumetric solutions in sufficient quantities as per the method given in the file.
5.5 Store the prepared solutions in a clean dried bottle.
5.6 Standardise the solutions in duplicate as per the method .
5.7 Label the bottle which contain the following details.
On one label                          On Second label
Name of the reagent                Date of Standardization
Strength                                  Strength (M)
Method as per                        Strength (N)
Solvent used                           Standardized by (sign)
Volumetric Reagent No.          Re-standardizing due on
Storage condition                   Checked by
5.8 Assign restandardizing due date after 30 days for all the volumetric solutions except Perchloric acid and Sodium thiosulphate for which it should be 15 days and for Iodine it should be standardized at the time of use .
5.9 Standardise the solutions periodically as per restandardizing due date and maintain the results in the file duly signed.
5.10 Prepare all volumetric solution freshly after 3 months and destroy the old solution and standardize the fresh solution as per 5.9

5.11 Limit : Difference between two sets of Normality/ Molarity should not more than 0.5 %
Volumetric solution should not differ from the prescribed strength by more than 10 %

6.0 ABBREVIATIONS

6.1 SOP -Standard Operating Procedure
6.2 AR= Analytical grade





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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