Primary Standards(Reference Standards) Preparation and Storage

1.0 OBJECTIVE

To lay down the procedure for Preparation and Storage of Primary Standards. 

2.0 SCOPE

This SOP is applicable for preparation and storage of primary standards in Analytical research department at company Name.

3.0  BACKGROUND

NIL

4.0 RESPONSIBILITY

4.1 All Analytical research personnel shall follow the SOP.

4.2 Group leader of Analytical research shall ensure the procedures to be followed.

4.3 Head Analytical research or his designee to ensure overall compliance.

5.0 PROCEDURE

5.1 Preparation and storage

5.1.1 Primary standards are used for standardizing volumetric solutions, preparation of pH buffers, preparation of limit test standard solutions, colorimetric standard solutions etc..Primary standards shall be dried in a shallow weighing bottle at specified temperature  and time as mentioned in the respective GTP / STP.

5.1.2 At the time of drying the weighing bottle shall be labeled with the name of primary standard by using blue colour pen marker. After drying is over it shall be labeled with details as per Annexure-2.

5.1.3 Primary standards after drying, shall be cooled to room temperature in desiccator.

5.1.4 Dried primary standards shall be opened for a minimum time while using and after use they shall be replaced immediately in desiccator.

5.1.5 Enter the details of drying in “ Primary Standards drying Register ” (Annexure-1).

5.1.6 After drying, the primary standards shall be used within 8 days from the date of drying.

5.1.7 Destruction of primary standards should be done as per MSDS.

5.2 Numbering System of Primary standards

5.2.1 Each primary standard dried shall be identified with a unique identification number / lot  number / reference number.

5.2.2 Primary standard lot number shall consist for eight characters.

5.2.3 The first two characters are PS indicating primary standard.

5.2.4 The next three characters indicate the serial number in sequential order starting from 001 every new year ( from 1st January).

5.2.5 Sixth character denotes “-“ ( dash ) and next two characters denotes last two digits of  the current year.

Example: The lot number for the first primary standard dried in year 2015 shall be given as PS001-15.

5.3 Reference number / lot number of primary standard shall be documented in the respective record of analysis of that  particular material / product

 6.0 REFERENCES

NIL

7.0 VERSION HISTORY

8.0 ANNEXURES

NIL