IVEE INFUSIONS EPZ LTD

Standard Operating Procedure LIMIT TEST FOR IRON IN WATER

S.O.P. No. QC SOP Effective Date
Department Quality Control Page 1 of 4
Name Position Signature Date
Author
Approval
Approval
Authorized By

1 CHANGE HISTORY

Issue No. DCN No. Change Description (as applicable)

01 N/A New Document

 IVEE INFUSIONS EPZ LTD
Standard Operating Procedure LIMIT TEST FOR IRON IN WATER
S.O.P. No. QC SOP 032 01 Effective Date
Department Quality Control Page 2 of 4

2 PURPOSE

To provide a guideline on carrying out a limit test for iron in water.

3 SCOPE
This SOP covers the testing of purified water return and water for injection return.
4 REFERENCES
USP NF 31 specifications

5 RESPONSIBILITIES
It is the responsibility of the Chemistry analyst to adhere to all laid down steps in this SOP
during sample preparation. Testing and reporting of results.
It is the responsibility of the QCM to ensure that this SOP is duly followed when
performing water test.
The QAM is accountable to all the activities undertaken in this SOP.
6 REQUIREMENTS
6.1.1 Ensure the water sample is collected as per SOP for water sampling.
6.1.2 Ensure that the analytical reagents are not expired before use.
6.1.3 Ensure all glassware have been cleaned and dried following the SOP for preparation of
glassware prior to use.
6.1.4 Perform verification of the analytical balance daily using certified reference weights
before use.
 IVEE INFUSIONS EPZ LTD
Standard Operating Procedure LIMIT TEST FOR IRON IN WATER
S.O.P. No. QC SOP 032 01 Effective Date
Department Quality Control Page 3 of 4

6.1.5 APPARATUS
 50ml Boiling tubes

 2ml pipette

 1ml pipette

 25ml pipette

 5 ml pipette

 250ml volumetric flasks

 250ml reagent amber bottles

 Ammonia

 Citric acid

 Thioglycollic acid

 Analytical balance

 Weighing boats

7.0PROCEDURE
7.1Preparation of 5M Ammonia solution

7.1.15 Measure 79.3ml of 30%Ammonia solution AR

7.1.16 Introduce slowly to a 250ml volumetric flask containing 100ml.Make to volume
7.1.17 Allocate the reagent reference number to the reagent as follows;
Cr/No.of preparation/stock number /year of preparation
7.1.18 Label the prepared solution appropriately using standard reagent label.

7.2Preparation of 200g/l Citric acid (20%w/v)

7.2.15 Weigh approximately 50 grams of Citric acid on the analytical balance
7.2.16 Transfer to 250ml volumetric flask containing about 100ml of purified water and
make to volume.
7.2.17 Allocate the reagent reference number to the reagent as follows;
Cr/No.of preparation/stock number /year of preparation
Label the reagent using the standard reagent label.
 IVEE INFUSIONS EPZ LTD
Standard Operating Procedure LIMIT TEST FOR IRON IN WATER
S.O.P. No. QC SOP 032 01 Effective Date
Department Quality Control Page 4 of 4

7.3Testing for Iron

7.3.15 Measure 10ml of sample
7.3.16 Add 2ml of 20%w/v Citric acid
7.3.17 Add 0.1ml of Thioglycollic acid
7.3.18 Mix and add 1ml of 6m Ammonia
7.3.19 Dilute to 20ml with water( Iron free water)
8.0 Acceptance criteria
 After 5 minutes any pink color in the test solution is not more intense than that in
the standardthus complies with limit test for Iron
 If after 5minutes the test forms pink color that is more intense than the standard
prepared thus fails to comply with the limit test for Iron.
9.0 RECORDS
Record the reagent preparation in the reagent preparation book.
Record the test results in the daily water analysis log book and forms.

ABBREVIATIONS
QCM: Quality control manager.
QAM: Quality assurance manager.
USP: United states pharmacopeaia.