SOP for Preparation and Handling of Primary Standard

1.0 OBJECTIVE

To establish a procedure for preparation and handling of the primary standard.

2.0 SCOPE

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

3.0 RESPONSIBILITY

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

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

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.
X/OO/A/BB
Where X corresponds to 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 to the last digit of the 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 an 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 the primary standard after completion of shelf life and keep the record as per Annexure-II.

Related: Maintenance of Primary Standards in Pharmaceutical Industries

5.0 ABBREVIATIONS

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

ANNEXURE-I

LIST OF PRIMARY STANDARD

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

ANNEXURE-II

PRIMARY STANDARD BINCARD

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	Remark

No. of Vials remaining on Expiry    :

No. of Vials destroyed                     :

Vials destroyed on                           :

Vials destroyed by                           :

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