SOP for Preparation, Standardization & Storage of Volumetric Solutions

OBJECTIVE

To lay down a procedure for the Preparation and Storage of Volumetric Solutions 

SCOPE

This SOP shall be applicable for the preparation of all Volumetric Solutions, which are to be used during the analysis in the quality control department.

RESPONSIBILITY

• It is the responsibility of the assigned QC Executive to follow this procedure. 
• It is the responsibility of the Manager QC to ensure that the procedure is followed fully and the necessary documentation is completed. 

PROCEDURE

• Ensure that the chemical used for the preparation of volumetric solutions is within the expiry. 
• Prepare, standardize, and store the volumetric solutions in sufficient quantities as per the respective Pharmacopoeia 
• Dilute volumetric solutions (e.g. in the order of 0.001N) should be prepared fresh for each day’s use by diluting a more concentrated volumetric solution (e.g. 0.01N or 0.1N) to use. 
• All the volumetric solutions prepared should be mentioned in Attachment-I (List of volumetric solutions) along with their reference number (procedure for reference number described below) 
• Standardize the solutions in triplicate and note the Normality / Molarity up to five decimal places %RSD between three sets of Normality / Molarity should not be more than 0.5 %. 
• The volumetric solution shall not differ from the prescribed strength by more than 10%, if it does discard the solution and prepare a fresh solution. 
• Maintain the record of preparation and standardization of volumetric solution in attachment II. 
• Assign 1-month use before the date for all volumetric solutions from the date of preparation.
• Upon preparation fill the solution in a cleaned & dried suitable bottle. Prepare the label as per Attachment-III and affix it to the bottle. 
• Assign a reference number to each volumetric solution as follows and maintain the list as per Attachment-I.

        VS-AA 

Where 

VS = Volumetric solution 

AA = Sr. Number of volumetric solutions starting from 01. 

• Assign the ID number of each volumetric solution after standardization as follows:

              VS-AA/BB/CC/DD/EE 

Where, 

AA = Sr. number of volumetric solution starting from 01 

BB = Current year 

CC = Current month 

DD = Serial number of preparation starting from 01. 

EE = Serial number of standardization starting from 01.

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• Before using any volumetric solution check for use before the date and clarity of the solution. If the solution is found hazy destroy the same and prepare the fresh solution and maintain the record. 
• Prepare a fresh solution after the use before the date of the volumetric solution. 
• All the Volumetric solutions shall be stored under ambient conditions unless otherwise specified in the pharmacopeia. All hydroxide standard solutions should be stored in HDPE bottles and all acids should be stored in glass bottles. 

ABBREVIATION

USP – United States Pharmacopeia

BP – British Pharmacopeia

QC – Quality Control

HDPE- High-Density Polyethylene

ATTACHMENT

Attachment-1 -- List of Volumetric Solutions 

Attachment-2 -- Preparation and standardization record of volumetric solution 

Attachment-3 -- Specimen format for Label of Volumetric Solution

REVISION HISTORY

Nil

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