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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

Sr. No.

 

Tests

 

Specifications

PHYSICAL ANALYSIS

1

Physical Form

Liquid

2

Colour

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

Pink color should not disappear completely

11

Test for Total Solid Contents

Should not be more than 1ppm



SAMPLING

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 

Sr. 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

Sr. No.

Name

Quantity

1

Dilute Sulphuric Acid

5 ml

2

Silver Nitrate TS

2 ml

3

Barium Chloride TS

2 ml

4

Ammonium Oxalate

2ml

5

0.1N Potassium Permanganate

1ml

6

Saturated Potassium Chloride

0.5ml

7

Calcium Hydroxide TS

25ml



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 sample 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 sample in 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 produce.

Identification Test of Chloride
Take 5ml of the sample in the test tube, and add 2ml of Silver Nitrate TS; No white precipitate should produce.

Identification Test of Calcium Ion
Take 5ml of the sample in the test tube, and add 2ml of Ammonium Oxalate TS; No turbidity should produce.

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 sample in the beaker, add 5ml of dilute sulphuric acid, heat it to boil on the Bunsen burner, 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 sample in a 100ml beaker and check the total solids contents using TDS meter; it should not be more than 1ppm.

Record the result of chemical analysis on the quality report.

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

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