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Cefuroxime Axetil Raw Material Testing Procedure

As we know Cefuroxime is used to treat a variety of bacterial infections. This drug is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria. This antibiotic only treats bacterial infections. It does not work for viral infections (like cold, flu). In this post, we are going to share  Cefuroxime Axetil Raw Material Testing Procedure. You may also check our other Testing procedures here

Here is the complete process of Cefuroxime Axetil Raw Material Testing with steps

1.0 PURPOSE

It is established to describe the specification and analysis of Cefuroxime Axetil Crystalline Special, which is one of the components of Suspension.

2.0 SCOPE

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

3.0 REFERENCES

BP/USP/in-house

4.0 DEFINITIONS

Follow SOPs

5.0 SPECIFICATIONS

BP/USP/in-house

PHYSICAL ANALYSIS

1. Physical Form Crystalline Powder
2. Colour White to almost white
3. Solubility Slightly soluble in water & ethanol and soluble in acetone.
4. Loss on drying Not more than 1.5%
5. Water Contents(by Karl Fischer) Not more than 1.5%

CHEMICAL ANALYSIS

1. Identification of Cefuroxime By IR Spectrum Should Comply With Standard Spectrum
2. Identification of Cefuroxime Reddish-brown Colour should produce
3. Contents of Cefuroxime Should be between 79.8—84.8%. calculated concerning anhydrous substance.

6.0 SAMPLING

Refer to the Incoming SOPs for sampling.

7.0 REJECTIONS:

If the Cefuroxime Axetil Crystalline Special Suspension Grade does not satisfy the specifications mentioned in 5.0 then it will be rejected. In addition to the specifications, Cefuroxime Axetil Crystalline Special 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

Cefuroxime Axetil Crystalline Special is received in a plastic/ metallic container or in any other packing placed in a sturdy, cardboard container to protect it from moisture and light.

9.0 STORAGE:

Store in an airtight container, protected from light at a temperature not exceeding 25°C.

10.0 HANDLING

Use gloves & mask during weighing and dispensing operation of Cefuroxime Axetil Crystalline Special and keep the container well closed immediately after use. Keep the container back to its specified area.

11.0 ANALYSIS

11.1 (A) Suitable Machinery/Equipment/Apparatus

PHYSICAL

  • Analytical Balance
  • Moisture Balance
  • Test Tubes

CHEMICAL

  • UV Spectrophotometer.
  • Volumetric Flask, 100 ml,
  • Pipette 1 ml (Bulb Type),
  • Analytical Balance, Magnetic Stirrer, Funnel
  • Test tube, Filter Paper Whatman No. 41.
  • FTIR, Mortar And Pestle

Chemicals

1. Potassium Bromide-IR-Grade 200mg
2. Sulfuric acid 10 ml

Reagents

1 Phosphate Buffer Solution PH7 300ml
2 I N sodium Hydroxide 250 ml
3 Sulfuric acid Formaldehyde reagent 2 ml

11.2 PHYSICAL ANALYSIS:

BP/USP/in-house

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; it should be white to almost white.

11.2.3 Test of Solubility:

Check The Solubility of the sample in water, ethanol and acetone respectively, it should be slightly soluble in water and ethanol and soluble in acetone.

11.2.4 Test of Loss on Drying:

Weigh accurately 10 g of sample on moisture balance. Adjust the temperature at 105°C, start drying the sample. In the end, the balance shows a percentage loss of moisture; it should not be more than 1.5%.

11.2.5 Water Contents:

Weigh accurately 50mg of sample and titrate for Karl Fischer water determination it should be no more than 1.5%.

11.3 Record the result of Physical Analysis on the quality report.

11.4 CHEMICAL ANALYSIS: BP/USP/inhouse

11.4.1 Identification Test of Cefuroxime:

11.4.1.1 Examination of Cefuroxime Axetil Crystalline by IR spectrum:

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

11.4.1.2 Take a sample equivalent to 2 mg of Cefuroxime, put it in the test tube. Moist it with 0.05 ml of Distilled water and add 2 ml of sulfuric acid-formaldehyde reagent. Mix swirlingly, the solution becomes pale brown. Place the test tube in the water bath for one-minute, reddish-brown colour is obtained.

11.4.2 Contents of Cefuroxime

11.4.2.1 Standard Preparation:

Weigh accurately on analytical balance std. Cefuroxime Axetil is equivalent to100 mg of Cefuroxime & dissolve in 50 ml of 1N sodium hydroxide & make the volume up to 100ml. Take 1 ml from it & make the volume up to 100 ml with phosphate buffer pH 7.0 mix well and filter.

11.4.2.2 Sample Preparation:

Weigh accurately on analytical balance 100 mg of sample & dissolve it in 50 ml of 1N sodium hydroxide & make the volume up to 100ml. Take 1 ml from it & make the volume up to 100 ml with phosphate buffer pH 7.0, mix well and filter. Measure the absorption of sample and std taking phosphate buffer pH 7.0 as a blank at 274 nm.

11.4.2.3 Blank Preparation:

Filter Phosphate Buffer PH7 and take 40 ml of phosphate buffer pH 7.0. Measure the absorption at 274 nm on U.V-Visible Spectrophotometer.

11.4.2.4 Observations:

a) Absorption of std: A

b) Absorption of sample: B

c) Record the reading.

11.4.2.5 Calculations:

Calculate the contents of Cefuroxime as follows:
             B
——————— x 100 = C
            A

Limit: The contents of Cefuroxime should be between 79.8—84.8%. calculated with reference to an anhydrous basis.

11.5 Record the result of Chemical Analysis on the quality report.

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

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