SOP Title: Procurement and Handling of Primary Standards

1. Objective:

To lay down the procedure for Procurement and Handling of Primary Standards.

2. Scope:

This SOP is applicable for Procurement and Handling of Primary Standards in Quality Control Department.

3. Responsibility:

• Quality Control Department: To prepare and review the SOP. To follow the procedures laid down for Procurement and Handling of Primary Standards in Quality Control Department as per this SOP.
• Quality Assurance Department: To review and approve the SOP and Annexures.

4. Accountability:

Head Quality Control Department, Head Quality Assurance Department

5. Procedure:

5.1	Procurement and Handling of Primary Standards :
5.1.1	Current batch of AR grade Primary Standards should be procured from an authorized supplier of manufactured by Merck, S.D. Fine, Loba, Rankem, Himedia, Fischer etc.
5.1.2	For receipt of Primary Standards refer SOP “Receipt, Storage and Handling of Chemicals in Laboratory”.
5.1.3	Certificate of Analysis should be received with Primary Standards or it can be downloaded from internet and record to be maintained.
	Note: Commercially available very pure chemicals shall be used as primary standards.
5.1.4	Validity of Primary Standards shall be defined as two years after date of opening of the containers, if physical properties are same as initial. If the expiry date of Primary Standard is defined by the manufacturer earlier than two years from the date of opening then assign validity same as manufacturer’s expiry date.
	Example: If the analyst opens Potassium Chloride bottle on 25/04/24, then the date of opening shall be 25/04/24 and the validity shall be 24/04/26.
5.1.5	After receiving the Primary Standards, they should be labelled with detailed information as per Annexure.
5.1.6	Allocate primary standard number to Primary Standard as below: PS/XX/YY/NNN Where: PS: Primary standard XX: Serial Number of the Primary Standard YY: Current year NN : Serial number of received Primary Standard
5.1.7	Primary Standards should be stored in tightly closed container at room temperature or at specified storage conditions on containers or certificate.
	Note: Clean the outer Surface of bottle with tissue paper before use.
5.1.8	Maintain Primary Standard Receipt and Usage Record as per Annexure
5.1.9	Primary Standards after drying under the specified conditions are recommended to use as Primary Standards for standardization of Volumetric Solutions.
5.1.10	Immediately after use of a Primary Standard, it should be restored back to its storage place.
5.1.11	During use or drying of Primary Standards don not put back the withdrawn material from the container.
5.1.12	Primary standards should not be used after the validity period. It should be consider as general chemical and can be used for routine analysis till the expiry/validity period as defined for general chemical after opening.
5.1.13	Expired primary Standard should be destroyed as per SOP “Destruction of Laboratory Waste”.
	If any primary standard shows deterioration e.g. crystallisation, discoloration, sedimentation, precipitation, change in physical appearance shall be discarded regardless of validity.

 

6. Definitions / Abbreviations:

• Definitions :
• Abbreviations :

Abbreviation	Expansion
AR	Analytical Reagent
No.	Number

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.