Preparation and Standardization of volumetric solution

 

1.0 OBJECTIVE

1.1 To lay down a procedure for Preparation & Standardization of Volumetric solution in Quality Control
Department.

2.0 SCOPE

2.1 This procedure is applicable for procedure of Preparation & Standardization of volumetric solution

3.0 RESPONSIBILITY

3.1 QC Officer or QC Executive

4.0 ACCOUNTABILITY

4.1 QC Manager

5.0 PROCEDURE

5.1 Prepare the volumetric solutions according to the individual preparation monographs as given in the respective

pharmacopoeias. the method of expressing concentration in Normality or Molarity.
5.2 Store the standard solutions in clean, tightly closed containers with labels indicating the following
details:
5.2.1 Name of the volumetric solution
5.2.2 Date of preparation
5.2.3 Normality/molarity
5.2.4 Prepared by

5.2.5 Valid up-to-date

5.3 Use only clean, dry bottles for the storage of fresh standard solutions.
5.4 Ensure that no previous labels remain on the bottles. Use a new label for preparation. of each
Standardized solutions
5.5 Standardize the specific volumetric solution according to I.P. in duplicate against a primary standard solution.

Record the values as mean or average of the two observations (acceptance for two reading NMT 0.2%).
5.6 Use these solutions before the due date.
5.7 Record all the calculations, weights and normality in the standardized log book before using the solution visually

check that the bottles are clean and solutions are clear and that the solution has not gone beyond the “valid up-to-date”.

Discard any solution if it is not clear or has gone beyond the “valid up to” date Prepare fresh solution and standardize it.

6.0 ABBREVIATIONS

Abbreviation	Extended Form
QC	Quality Control
SOP	Standard Operating Procedure

Annexure-1
STANDARD OF VOLUMETRIC SOLUTION

Instrument ID:                                                                  Date:

 

Date	Calculation	Normality	Analyzed By	Checked By	Remark