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Sodium Citrate Raw Material Testing Procedure

Sodium Citrate Raw Material Testing Procedure, Specification & Analysis prescribes the requirements, It is applicable in material, Product Development and Quality of raw material to confirm its physical & chemical specifications.

1.0 PURPOSE

This raw material Specification & Analysis prescribes the requirements for Sodium Citrate, which is one of the components of powders.

2.0 SCOPE

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

3.0 REFERENCE

BP

4.0 DEFINITIONS

Follow SOP

5.0 SPECIFICATIONS BP

PHYSICAL ANALYSIS

  • Physical Form: Crystalline Powder or Granular crystals, slightly deliquescent in moist air.
  • Colour: White
  • Clarity and color: Clear and colorless
  • Solubility: Should be freely soluble in water & practically insoluble in ethanol

CHEMICAL ANALYSIS

  • Acidity or Alkalinity: Not more than 0.2ml of 0.1M Hydrochloric acid or 0.1M Sodium Hydroxide is required to change the color of the indicator.
  • Identification Test of Sodium: Golden yellow colour flame should produce.
  • Identification Test of Citrate: No white precipitate should produce, white precipitates should produce on boiling which are insoluble in 6Macetic acid.
  • Contents of Sodium Citrate: 99 to 101% calculated with reference to anhydrous substance.

6.0 SAMPLING

Refer to the Incoming SOPs for sampling.

7.0 REJECTIONS:

If the Sodium Citrate does not satisfy the specifications mentioned in 5.0 it will be rejected. In addition to the specifications, Sodium Citrate is also rejected due to the following reasons:

7.1 If the receiving raw material is cross contaminated due to any reason.

7.2. The material does not bear 75% of its stated shelf life at the time of receipt.

8.0 PACKAGING

Sodium Citrate is received in plastic bottle to protect it from moisture and light.

9.0 STORAGE: BP

Store in an airtight container.

10.0 HANDLING

10.1 Use gloves & mask during weighing and dispensing operation of Sodium Citrate.

10.2 Keep the container of Sodium Citrate well closed immediately after use.

10.3 Place the container of Sodium Citrate back to its specified area.

11.0 ANALYSIS

11.1 (A) Suitable Machinery/Equipment/Apparatus

PHYSICAL

  • Beaker
  • Glass Rod
  • Test tubes
  • Graduated Pipette 1 ml, 5 ml
  • Analytical Balance
  • Beaker 100 ml
  • Burette 25 ml
  • Titration Flask 250 ml
  • Platinum Wire
  • Bunsen Burner

Chemicals

  • Ethanol 10 ml
  • Glacial Acetic Acid 60 ml
  • Acetone 10 ml
  • Conc. Hydrochloric Acid 1 ml

Reagents

  • 0.1 M Hydrochloric Acid Solution 5 ml
  • Phenolphthalein solution 2 ml
  • 0.1M Sodium Hydroxide Solution 1 ml
  • Calcium Chloride TS 2 ml
  • 0.1 M Perchloric Acid Solution 50 ml
  • Crystal Violet TS 1 ml
  • 6M Acetic Acid 10ml

11.2 PHYSICAL ANALYSIS

11.2.1 Test of Physical Form:

Check the sample and confirm its physical form; it should be crystalline powder or granular crystals, slightly deliquescent in moist air.

11.2.2 Test of Colour:

Confirm the colour of the material by comparing with standard form colour chart; it should be white.

11.2.3 Test of clarity and color:

Dissolve 5g of the sample in 50ml of distilled water; the solution should be clear and colorless.

11.2.4 Test of Solubility:

Check the solubility of the sample in water and ethanol.
It should be freely soluble in water, and practically insoluble in ethanol.

11.3 Record the result of physical analysis on Quality Report.

11.4 CHEMICAL ANALYSIS: BP

11.4.1 Acidity or Alkalinity

Dissolve of 1g of sample in 10ml of water and add 0.1ml of phenolphthalein solution; Not more than 0.2ml of 0.1M Hydrochloric acid or 0.1M Sodium Hydroxide is required to change the color of the indicator.

11.4.2 Identification Test of Citrate:

Weigh accurately on analytical balance 20 mg of the sample, put it in test tube, add 10 ml of distilled water and 1 ml of Calcium Chloride TS; No white precipitate should produce, white precipitates should produce on boiling which are insoluble in 6M acetic acid.

11.4.3 Identification Test of Sodium:

Make the paste of 500 mg of the sample with 0.5 ml of concentrated hydrochloric acid, Moisten the platinum wire with the paste and introduce into the flame of a Bunsen Burner; Golden yellow colour flame should produce.

11.4.4 Contents of Sodium Citrate:

11.4.4.1 Sample Preparation:

11.4.4.1.1 Wash the apparatus with acetone and allow to dry it for 5 minutes.

11.4.4.1.2 Weigh accurately on analytical balance 150 mg of the powdered sample of Sodium Citrate, put it in 250ml titration flask, add 25 ml of glacial acetic acid.

11.4.4.13 Titrate step 11.4.4.1.2 with the help of 25ml burette with 0.1 M Perchloric Acid solution using Crystal Violet Solution as an indicator.

11.4.4.2 Blank Preparation:

11.4.4.2.1 Wash the apparatus with acetone and allow to dry it for 5 minutes.

11.4.4.2.2 Take 25 ml of glacial acetic acid in 250 ml titration flask

11.4.4.2.3 Titrate step 11.4.4.2.2 with the help of 25ml burette with 0.1 M Perchloric Acid solution using Crystal Violet Solution as an indicator.

11.4.4.3 Observations:

a) Volume of 0.1 M Perchloric Acid used
for sample = C
b) Volume of 0.1 M Perchloric Acid used
for blank = D
c) Difference: C-D=E
e) Record the reading.

11.4.4.4 Calculations:

Calculate the contents of Sodium Citrate as follows:
Factor: Each ml of 0.1 M Perchloric Acid is equivalent to 8.602 mg of Sodium Citrate.
                    8.602 x E
—————————————- X 100 = F
                     150

Limit: The contents of Sodium Citrate should be between 99-101% calculated with reference to anhydrous substance.

11.5 Record the result of chemical analysis on Quality Report.

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

11.6 Total No. of Worker/Officer and Time.
Officer = 2 Worker = 3 Total Time consumed = 1:00 Hours

 

 

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