Preparation standardization and storage of volumetric solution

1.0 Purpose
1.1 To describe a procedure for preparation, standardization and storage of volumetric solutions used for chemical analysis.

2.0 Scope
2.1 This standard operating procedure is applicable for preparation, standardization and

storage of volumetric solutions used for chemical analysis in Quality Control laboratory at ABC Pvt. Ltd.

3.0 Responsibility
Officer QC/ Executive QC Preparation of SOP and follow the procedure as per SOP
Assistant Manager Reviewing and Training of SOP
Manager QC Implementation of SOP
4.0 Accountability
4.1 Manager Quality Control is accountable for implementation and compliance with SOP.

5.0 Procedure
5.1 All the volumetric solutions used in the chemical analysis shall be prepared once in a month

and standardization initially after preparation.
5.2 Concentration of volumetric solution shall be indicated in term of

Molarity (i.e. Number of moles dissolved in one liter of solution).
5.3 Officer QC shall ensure that volumetric solutions shall not differ by

more than 5.0% of prescribed strength.
5.4 Molarity of prepared volumetric solutions shall be determined with

a precision of 0.2% RSD.
5.5 The volumetric solutions shall be destroyed after one month or two month interval

as the case may be, and fresh solutions shall be prepared. If required, solutions shall be prepared more frequently.
5.6 The Officer QC shall ensure that the volumetric solutions are not used if any fungal growth,

sedimentation or turbidity/ precipitation are observed
5.7 Preparation
5.7.1 All the volumetric solutions shall be prepared as per the procedure mentioned in respective

Standard Test Procedures (STPs) and fill the record in Annexure I and Annexure II.
5.7.2 Use only AR grade chemicals for the preparation of volumetric solutions.
5.7.3 All chemicals / solvents, used, for preparation of volumetric solution shall be checked for

expiration date (mentioned on the label) and appearance before preparation. Expired

chemicals / solvents shall not be used and shall be immediately removed from the stock.
5.7.4 Only purified water shall be used for preparation of volumetric solution, unless otherwise specified.

5.8 Standardization
5.8.1 All volumetric solutions shall be standardized after preparation as per the respective Standard Test Procedure.
5.8.2 Volumetric solutions shall always be standardized with primary standard reagent

or equimolar solution, whichever is applicable.
5.8.3 Primary standards / reagents shall be procured with the certificate of analysis.

The primary standards shall be labeled with name of the standards, manufacturer’s name,

batch no., and date of replacement and to be used before date. Primary standards shall be replaced

before the expiry mentioned on the manufacturers label.
Note: Do not use primary standards beyond expiry date.
5.8.4 Dry Primary volumetric standards at specified conditions, as mentioned in the Certificate of

analysis provided by the manufacturer, and then cool in silica gel under desiccators.
5.8.5 Three consecutive determinations shall be done.
5.8.6 Calculate the strength of the volumetric solution as per the following formula
(whichever is applicable)

Where,

W = Weight taken of primary standard in gms.

V = Volume of titrant (i.e. to be standardized) consumed in ml

F = Equivalent factor for corresponding solution.

5.8.7 Record the calculations for the standardization of volumetric solutions on Annexure I and Annexure II.
5.8.8 Data shall be recorded and calculated in respective calculation sheet and should meet the acceptance criteria.

5.9 Storage
5.9.1 Store all the volumetric solutions as per the condition mentioned in the preparation and

standardization procedure, in a labeled and tightly Stoppard container.
5.9.2 Store all the primary volumetric standards as per the conditions mentioned in the

Certificate of analysis provided by the Manufacturer.
5.9.3 Give preparation code No. for the volumetric solution as per following manner
e.g. VS/XX
Where,
VS: Volumetric Solution
XX: No. of beginning 01
5.9.4 If any abnormality during preparation and standardization is observed inform to Manager Quality Manager.

6.0 Reference
IP/BP/USP/In-house

7.0 Attachments
Annexure I : Preparation and standardization of volumetric solutions by weight/volume

Annexure II : Preparation and standardization of volumetric solutions by volume/volume
Annexure III: Preparation and standardization of volumetric solutions Record

8.0 Distribution
Distribution of the controlled copy to concerned departments.
Additional copies may be issued for specific purpose.

9.0 Abbreviations
QA : Quality Assurance
QC : Quality Control
SOP : Standard Operating Procedure
VS : Volumetric Solution
% : Percentage
RSD : Relative Standard Deviation
AR : Analytical

10.0 Revision History