SOP for Preparation, Standardization & Storage of Volumetric Solutions

OBJECTIVE:

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

SCOPE: 

This SOP shall be applicable for preparation of all Volumetric Solutions, which are to be used during analysis in 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 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 solution prepared should be mentioned in the Attachment-I (List of volumetric solution) 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 %. 
• Volumetric solution shall not differ from the prescribed strength by more than 10%, if it does discard the solution and prepare fresh solution. 
• Maintain the record of preparation and standardization of volumetric solution in the attachment-II. 
• Assign 1-month use before date for all volumetric solution from the date of preparation.
• Upon preparation fill the solution in cleaned & dried suitable bottle. Prepare label as per Attachment-III and affix it on the bottle.  
• Assign reference number to each volumetric solution as follows and maintain the list as per Attachment-I.

        VS-AA 

               Where 

                    VS = Volumetric solution 

                     - = Separator 

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

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

              VS-AA/BB/CC/DD/EE 

                 Where, 

                      AA = Sr. number of volumetric solution starting form 01 

                      BB = Current year 

                      CC = Current month 

                      DD = Serial number of preparation starting form 01. 

                      EE = Serial number of standardization starting form 01. 

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

ABBREVIATIONS:

USP – United States Pharmacopeia. 

BP – British Pharmacopeia. 

QC – Quality Control 

HDPE- High Density Polyethylene 

ATTACHMENTS:

Attachment-1 -- List of Volumetric Solutions 

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

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

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