Procedure For Preparation of buffer solution
1.0 Objective
To set guidelines for the preparation of various Buffer solutions.
2.0 Scope
All Buffer solutions used in the QC Laboratory at abc Pvt. Ltd.
3.0 Responsibility
3.1 Executive – Quality Control.
3.2 In charge/Head-Quality Control.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QC : Quality Control
CC NO : Change Control Number
cGMP : Current Good Manufacturing Practice
G : General
5.0 Procedure
5.1 Preparation of Buffer Solution:
5.1.1 Wear surgical gloves and nose mask during preparation of buffer solutions.
5.1.2 Take appropriate glassware’s of suitable capacity to prepare the buffer solutions.
5.1.3 Take the fresh or stored materials of primary or secondary chemical
for the preparation of buffer solutions
5.1.4 Ensure that the chemical container bear the sticker containing date of opening.
5.1.5 Ensure that chemical is within ‘use before date’.
5.1.6 Prepare Buffer solutions as per IP/BP/USP/EP or respective In-House standard
test procedure for that particular buffer solution.
5.1.7 After preparation of buffer solution, give the sufficient time for saturation of the solution.
5.1.8 Filter the solution (if required) and transfer into its storage container.
5.1.9 Prepare the buffer solutions after every one month or when its physical appearance
changes which ever is earlier. Frequency of preparation buffer solutions is given
in their respective standard test procedure.
5.2 Storage :
5.2.1 Store buffer solutions in amber coloured bottles/polyethylene containers.
5.2.2 Check the appearance, crystallization, and sedimentation of the solution before using it for analysis.
5.2.3 If there is any change develops during storage, drain out the solutions and prepare fresh solution.
5.2.4 Prepare fresh Buffer solutions, which have been drained.
5.2.5 Do not use buffer solutions after one month from the date of preparation.
5.3 Precautions
5.3.1 Check that appearance of chemical used for preparation not change during storage period
Handle the chemical as per given instruction by the manufacturer.
5.3.2 Prepare highly inflammable chemical in fuming hood only.
5.3.3 Do not open the chemical container in front of mouth.
6.0 Forms and Records
6.1 None.
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Assurance, Quality Control
8.0 History
Revision Number | Details For Change |
Reason for Revision |
00 | New SOP | NA |
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