Get the latest updates from us for free
Android App

SOP for Preparation and Handling of Primary Standard

Standard operating procedure to prepare and handle primary standards used for standardisation of volumetric solution & calibration of instruments.


        To establish procedure for preparation and handling of primary standard.

2.0  SCOPE

        This procedure is applicable for primary standards which are to be used for standardization of volumetric solution & calibration of instrument.


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


        Head of the Department


5.1  Select A.R. grade of reagent/chemical preferably certified .
5.2  Distribute the sufficient quantity of the material as required for one time use into predefined no. of vials & record it.
5.3  Give the reference number to primary standard as follows.
        Where X corresponds the first alphabet of material.
        OO corresponds to Sr. number from 01 onward to have details of total Primary standard in quality control laboratory.
        A corresponds the last digit of year in which primary std is prepared
        BB corresponds the no. of vial prepared for particular primary standard starting from 01.
5.4  Store the material in light resistant glass vials closed with rubber bungs and sealed with Aluminium seal.  
5.5  Label the vials with the following details.
       1.  Name of primary standard
       2.  Ref. No.
       3.  Date of preparation
       4.  Use before
5.6  Store all vials of primary standard in A.C. control area as per Annexure-I.
5.7  For every calibration/standardization take always fresh and sealed vial of primary standard and record it in respective bin card as per annexure II. 
5.8  Destroy the expired vials of primary standard after completion of shelf life and keep the record as per Annexure-II.

Related: Maintenance of Primary Standards in Pharmaceutical Industries


6.1  AR  =   Analytical Reagent
6.2  Ref  =  Reference
6.3  No.  =  Number.
6.4  AC  =  Air condition
6.5  Sr.  =  Serial


Sr. No.
Name of Primary Standard
Ref. No.
Sr. No.
Name of Primary Standard
Ref. No.

Name of Primary Std.    :
Batch No.                       :
Date of Preparation       :
Use before                      :
No. of Vials prepared    :
Prepared By                  :
Sr. No.
Vial Ref. No.
Date of Issue
No. of Vial Issued
Balance Quantity
Issued By
No. of Vials remaining on Expiry    :
No. of Vials destroyed                     :
Vials destroyed on                           :
Vials destroyed by                           :

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.
.moc.enilediugamrahp@ofni :liamE Need Help: Ask Question

Be the first to comment!

Post a Comment