SOP on Procedure of volumetric solution preparation and standardization

SOP on Procedure of volumetric solution preparation and standardization

Objective:

To lay down a procedure for preparation and standardization of volumetric solution.

Scope:

This SOP is applicable for the preparation and standardization of volumetric solutions in a quality control laboratory in a pharmaceutical company name with location.

Responsibility:

An officer or above of QC Laboratory is responsible for following the procedure mentioned in this SOP.

Accountability:

Head QC and QA shall be accountable for compliance with SOPs.

Abbreviations and Definitions:

VS:Volumetric solutions

RSD: Relative Standard Deviation

Procedure:

Volumetric solutions, known also as Standard Solutions, are solutions of reagents of known concentration intended primarily for use in quantitative determinations. Concentrations are usually expressed in terms of normality.

Volumetric solution preparation:

Prepare a Volumetric solution of specific strength, wherever applicable, as per the procedure given in the appendix of Pharmacopoeia.

Volumetric solutions should not differ from the prescribed strength by more than 10% and the Normality /Molarity should be determined in triplicate and so that RSD is below 1.0 %.

For the preparation of dilute Normal and Molar solution, if required, the solution of standard Normality / Molarity may be diluted in exact proportion and the same shall be used and should be re-standardized either as directed for the primary standards or by comparing with other volumetric solutions having a known concentration.

When a solution is used in an assay in which the endpoint is determined by an electrochemical process (potentiometrically) the solution must be standardized in the same way.

The volumetric solution shall be used within one month of preparation. In case of any unusual observation, (Crystallization, sedimentation, Haziness, and decolorization) it shall be discarded.

Assign Sr number for volumetric solutions as follows

• VS/XX/YY
• Where
• VS: stands for volumetric solutions
• XX: stands for serial number
• YY : stands for the year

To ensure the stability of the volumetric solution, check the Normality and Molarity of the solution in triplicate at once every 5 days for one month and record the same. The RSD of all observations must be 1.0 %.

Standardization: Normality and Molarity determine in triplicate. The average of the three titrations shall be considered for calculation. Record raw data in Logbook.

Make an entry for Volumetric Standard Solution Logbook.

Re-standardization shall be done once in fortnightly.

After preparation & standardization of Volumetric solutions, paste the Label on the respective glass bottles and storage as per specified requirement or room temperature.

Forms and Records (Annexures)

Preparation and standardization of volumetric solution logbook-Annexure -I

Distribution

Master copy – Quality Assurance

Controlled copies – Quality Assurance & Quality Control

History                   

Annexure -I

Preparation  and Standardization of the volumetric solution Logbook

• Date of preparation
• B.No of    Primary Stand
• Date of Standardization
• Wt.of primary standard
• Burette Reading/ Normality / Molarity
• Mean Normality/ Molarity
• Valid up to 
• Prepared by
• Checked by

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