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Deionized Water Testing Procedure

Deionized Water Testing Procedure Raw Material specification & analysis prescribes the requirements with and Other Testing procedures.

Deionized Water Testing Procedure for Raw Material PURPOSE

Deionized Water Testing Procedure

PURPOSE

This raw material specification & analysis prescribes the requirements for De-ionized water, which is used in different pharmaceutical preparations.

SCOPE

It is applicable for the analysis of Do-ionized water manufactured in water treatment section.

REFERENCES

In-house

DEFINITIONS

Follow SOP determination Pharmaegg.com

SPECIFICATIONS In-house
PHYSICAL ANALYSIS
TESTS SPECIFICATIONS

1. Physical Form Liquid
2. Colour Colourless
3. pH Between 5.0 to 7.0 at 30°C
4. Conductivity Should not be more than 1.4µS/cm at 30°C

CHEMICAL ANALYSIS

4. Test for Sulphate Ion No turbidity should produce
5. Test for Chloride Ion No white Precipitate should produce
6. Test for Calcium Ion No turbidity should produce
7. Test for Oxidizable Substances Pink colour should not disappear completely
8. Test for Total Solid Contents Should not be more than 1ppm

SAMPLING

Deionized Water Testing Procedure Refer to the Incoming SOPs for sampling.

REJECTIONS:

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

PACKAGING

-NA-

STORAGE: In-house

Store in a tight container.

HANDLING

Use gloves & mask during dispensing operation of Deionized Water.
Keep the container of Deionized Water well closed immediately after use.
Place the container of Deionized Water back to its specified area.

ANALYSIS

Suitable Machinery/Equipment/Apparatus

PHYSICAL CHEMICAL

1. pH meter Test Tubes
2. 10ml volumetric cylinder Bunsen Burner
3. Optical checker Graduated Pipette 5ml, 1ml
4. Beaker 100ml Beaker 100ml
5. Glass Rod

List Of Reagent/Chemical

Chemicals

-NA-

Reagents

1 Calcium Hydroxide TS. 2 ml
2 Silver Nitrate TS 2 ml
3 Barium Chloride TS 2 ml
4 Ammonium Oxalate 5 ml
5 0.1N Potassium Permanganate 1 ml
6 Saturated Potassium Chloride 0.15 ml

PHYSICAL ANALYSIS In-house

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 naked eye; it should be colourless.

Test of pH:

Take 50ml of the sample in a 100ml beaker, add 0.15ml of Saturated Potassium chloride, check the pH on pH meter; it should be between 5.0 to 7.0 at 30°C +- 2°C.
Record the result on Water Analysis Report (Chemical & Physical).

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.

CHEMICAL ANALYSIS: In-house
Identification Test of Sulphate Ion:

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

Identification Test of Chloride:

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

Identification Test of Calcium Ion:

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

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 100ml beaker and check the total solids contents by using TDS meter; it should not be more than 1ppm.
Record the result on Water Analysis Report (Chemical & Physical).

Note. Incase of any non- conformance observed during Inspection and testing, Please Follow Quality System Procedure for Control of Non-Conforming Product.

RESPONSIBILITIES AND AUTHORITIES

1. Product Development Manager
2. Product Development Officer
3. Quality Control Manager
4. Quality Assurance Officer
5. Quality Assurance Assistant
6. Quality Assurance Attendant

COMPANY QUALITY FORMS:

Water Analysis Report (Chemical & Physical).

 

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