SOP for Water for Injection (Raw Material Specifications Analysis)

PURPOSE

This raw material specification & analysis prescribes the requirements for Water for Injection, which is used in different pharmaceutical preparations.

SCOPE

It is applicable in the Material, Product Development, and Quality Assurance Department to confirm its physical & chemical specifications.

RESPONSIBILITIES

Product Development Manager 

Product Development Officer 

Quality Control Manager 

Quality Assurance Officer 

Quality Assurance Assistant 

Quality Assurance Attendant

REFERENCE

USP

SPECIFICATIONS

No.	Tests	Specifications
PHYSICAL ANALYSIS
1	Physical Form	Liquid
2	Color	Colorless
3	pH	5.0 to 7.0 at 25°C ± 2°
4	Clarity	There should be no visible contamination
5	Conductivity	Should not be more than 1.4µS/cm at 30°C
CHEMICAL ANALYSIS
6	Test for Sulphate Ion	No turbidity should produce
7	Test for Chloride Ion	No white Precipitate should produce
8	Test for Calcium Ion	No turbidity should produce
9	Test for Carbon Dioxide	The mixture should remain clear
10	Test for Oxidizable Substances	The pink color should not disappear completely
11	Test for Total Solid Contents	Should not be more than 1ppm

SAMPLING

Refer to the Incoming SOP for Sampling Plan for Purified Water and Potable Water for sampling.

ALSO READ: SOP for Destruction of Sample after Analysis

REJECTIONS

• If the water for Injection does not satisfy the specifications mentioned in 5.0 it will be rejected. In addition to the specifications, Water for Injection is also rejected due to the following reasons:
• If the receiving raw material is cross-contaminated due to any reason. The material does not bear 75% of its stated shelf life at receipt.

PACKAGING

- NA - 

STORAGE

Store in a tight container.

HANDLING

• Use gloves & mask during dispensing operation of Water for Injection. Keep the container of Water for Injection well-closed immediately after use. Place the container of Water for Injection back in its specified area.

ANALYSIS

A. Suitable Machinery/Equipment/Apparatus 

No.	Physical	Chemical
1	Test Tubes	Test tubes
2	Beaker	Bunsen Burner
3	Glass Rod	Graduated Pipette 1 ml, 5ml
4	-	Beaker 100 ml
5	-	TDS meter

B.  List of Reagent/Chemical

No.	Name	Quantity
1	Dilute Sulphuric Acid	5 ml
2	Silver Nitrate TS	2 ml
3	Barium Chloride TS	2 ml
4	Ammonium Oxalate	2 ml
5	0.1N Potassium Permanganate	1 ml
6	Saturated Potassium Chloride	0.5 ml
7	Calcium Hydroxide TS	25 ml

ALSO READ: SOP for Stability Studies of Active Pharmaceutical Ingredients

PHYSICAL ANALYSIS 

Test of Physical Form:

Check the sample and confirm its physical form; it should be liquid.

Test of Colour

Check the color of the sample with the naked eye; it should be colorless.

Test of pH

Take 50ml of the samples in a 100ml beaker, add 0.15ml of Saturated Potassium chloride, and check the pH on the pH meter; it should be between 5.0 to 7.0 at 25°C ± 2°.

Test of Conductivity

• Take 30ml of the sample in a 50ml beaker; dip the cell of the conductivity meter. Slightly agitate the cell to remove the air bubble. Disable the auto temperature compensation mode and select the conductivity mode. Allow the reading to stabilize. When ready appears note down the reading.
• It should not be more than 1.4µS/cm at 30°C.
• Record the result of physical analysis on the Quality Report.

CHEMICAL ANALYSIS

Identification Test of Sulphate Ion

Take 5ml of the sample in the test tube, and add 2ml of Barium Chloride TS; No turbidity should be produced.

Identification Test of Chloride

Take 5ml of the sample in the test tube, and add 2ml of Silver Nitrate TS; No white precipitate should be produced.

Identification Test of Calcium Ion

Take 5ml of the sample in the test tube, and add 2ml of Ammonium Oxalate TS; No turbidity should be produced.

Identification Test of Carbon Dioxide

Take 25ml of the sample, and add 25ml of Calcium Hydroxide TS; the mixture should remain clear.

Identification Test of Oxidizable Substances

• Take 50ml of the samples in the beaker, add 5ml of dilute sulphuric acid, heat it to boil on the Bunsen burner, and add 0.5ml of 0.1N Potassium permanganate. Now again boil it on the Bunsen burner for 10 minutes; the pink color should not disappear completely.

Identification Test of Total Solid Contents

• Take 75ml of the samples in a 100ml beaker and check the total solids contents using a TDS meter; it should not be more than 1ppm.

Record the result of the chemical analysis on the quality report.

Note. In case of any non-conformance observed during Inspection and testing please Follow the Quality System Procedure for Control of Non-Conforming Products.

ALSO READ: SOP for Receipt and Handling of Laboratory Samples