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Determination of Chlorpheniramine Maleate Raw Material

Chlorpheniramine Maleate Testing Procedures and specification & analysis prescribes the requirements for Determination of Chlorpheniramine Maleate Raw Material, which is one of the components Alternate Method of Analysis on UV System and Other Testing procedures

1.0 PURPOSE

This raw material specification & analysis prescribes the requirements for Chlorpheniramine Maleate, which is one of the components Syrup and Tablet.

2.0 SCOPE

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

3.0 REFERENCES

USP/BP/BP/Inhouse

4.0 DEFINITIONS

Follow the SOPs

5.0 SPECIFICATIONS

USP/BP/BP/Inhouse

PHYSICAL ANALYSIS

  • Physical Form Crystalline Powder
  • Colour White
  • Odour Odourless to almost Odourless
  • Solubility Freely soluble in water and Chloroform
  • Melting Point 130 to 135°C
  • Loss on Drying Not more than 0.5%
  • Clarity & Colour Clear and Colourless
  • Bulk Density 0.500 – 0.550 g/ml
  • Tapped Density 0.650 – 0.750 g/ml

CHEMICAL ANALYSIS

  • Identification of Chlorpheniramine Maleate examination by IR spectrum Should comply the standard spectrum
  • Identification Test of Chlorpheniramine Maleate White precipitate should produce
  • Contents of Chlorpheniramine Maleate 98 to 101%

6.0 SAMPLING

Refer to the Incoming SOPs for sampling.

7.0 REJECTIONS:

If the Chlorpheniramine Maleate does not satisfy the specifications mentioned in 5.0 then it will be rejected. In addition to the specifications, Chlorpheniramine Maleate 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

Chlorpheniramine Maleate is received in polyethylene bag placed sturdy, metallic/cardboard container to protect it from light.

9.0 STORAGE: BP

Store in well-closed container protected from light.

10.0 HANDLING

10.1 Use gloves & mask during weighing and dispensing operation of Chlorpheniramine Maleate.
10.2 Keep the container of Chlorpheniramine Maleate well closed immediately after use.
10.3 Place the container of Chlorpheniramine Maleate back to its specified area.

11.0 ANALYSIS

11.1 (A) Suitable Machinery/Equipment/Apparatus

  • Moisture Balance
  • PH Meter
  • Test Tubes
  • Beaker
  • Glass Rod
  • Melting Point Apparatus
  • Test tubes
  • Volumetric Flask 100 ml
  • Graduated Pipette 1 ml
  • Titration Flask 100 ml
  • U.V. Spectrophotometer
  • Analytical Balance
  • Magnetic Stirrer
  • Funnel
  • Filter Paper Whatman No. 41
  • Spatula
  • FTIR,mortar & pestle

11.1 (B) List Of Reagent/Chemical

  • Potassium bromide IR grade 200 mg
  • Chloroform 10 ml
  • 0.5 N Sulphuric Acid 250 ml
  • Trinitrophenol (Picric Acid) TS 1 ml

11.2 PHYSICAL ANALYSIS USP/BP/BP/Inhouse

11.2.1 Test of Physical Form:

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

11.2.2 Test of Colour:

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

11.2.3 Test of Odour

Check the odour of the sample; it should be odourless to almost odourless.

11.2.4 Test of Solubility

  • Check the solubility of the sample in water and chloroform.
  • It should be freely soluble in water and chloroform.

11.2.5 Test of Melting point:

Take the powdered sample in the capillary tube meant for the purpose, put it in the Melting Point Apparatus. Check the temperature at which the powdered sample melts; melting point should be between 130-135°C.

11.2.6 Test of Loss on Drying:

Weigh accurately 10 g of sample on moisture balance. Adjust the temperature at 105°C, start drying the sample. At the end balance show percentage loss of moisture; moisture contents should not be more than 0.5%.

11.2.7 Test of Clarity & Colour:

Dissolve 10 g of the sample in 100 ml of distilled water; the solution should be clear and colourless.

11.2.8 Bulk Density:

Take sample in the measuring cylinder, the surface level of the sample in the cylinder should be even, note the volume without tapping, it should be between 0.500 – 0.550 g/ml.

11.2.9 Tapped Density:

Take sample in the measuring cylinder, the surface level of the sample in the cylinder should be even, note the volume with tapping, it should be between 0.650 – 0.750 gm/ml.

11.3 Record the result of Physical Analysis on qualty report.

11.4 CHEMICAL ANALYSIS: USP/BP/BP/Inhouse

11.4.1 Examination of Chlorpheniramine Maleate by IR spectrum:

Take dried sample to 5mg of Chlorpheniramine Maleate and thoroughly mix with 95mg of dried standard of potassium bromide in pastel mortar.
Fill Macro cups with provided funnel like instrument and draw the spectrum it should be complies the standard spectrum.

11.4.2 Identification Test of Chlorpheniramine Maleate:

Weigh accurately on analytical balance 50 mg of the powdered sample, put it in the test tube, add 5 ml of distilled water, 1 ml of trinitrophenol TS; white precipitate should produce.

11.4.3 Contents of Chlorpheniramine:

11.4.3.1 Sample Preparation:

11.4.3.1.1 Weigh accurately on analytical balance 100 mg of the powdered sample of Chlorpheniramine Maleate, make the volume upto 100 ml with 0.5 N Sulphuric Acid in the volumetric flask.

11.4.3.1.2 Take 1 ml from the step 11.4.3.1.1 and make the volume upto 100 ml with 0.5 N Sulphuric Acid in the volumetric flask and filter it in 100 ml titration flask.

11.4.3.1.3 Measure the absorption of step 11.4.3.1.2 at 262 nm on U.V Spectrophotometer

11.4.3.1.4 Value of E (1%, 1 cm) is 212.

11.4.3.2 Blank Preparation:

11.4.3.2.1 Take 40 ml of 0.5 N Sulphuric Acid and filter it in 100 ml titration flask.

11.4.3.2.2 Measure the absorption of step 11.4.3.2.1 at 262 nm on U.V Spectrophotometer.

11.4.3.2.3 Value of E (1%, 1 cm) is 212.

11.4.3.3 Observation:

a) Absorption of Sample Preparation = A
b) Record the reading.

11.4.3.4 Calculations:

Calculate the contents of Chlorpheniramine Maleate as follows:
         A
—————– x 100 = B
        212
Limit: The contents of Chlorpheniramine Maleate should be between 98-101%.

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.

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