Furazolidone Raw Material Testing Procedure, It is applicable in Material Department, Product Development and Quality Assurance Department to confirm its physical and chemical specifications. This raw material specification & analysis prescribes the requirements for Furazolidone, which is one of the components of Furazolidone Raw Material Testing Procedure.
1.0 PURPOSE
This raw material specification & analysis prescribes the requirements for Furazolidone, which is one of the components of Furadil-F Suspension.
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
4.0 DEFINITIONS
Follow SOP
5.0 SPECIFICATIONS USP/BP
PHYSICAL ANALYSIS
| SR. No. | TESTS | SPECIFICATIONS |
| PHYSICAL ANALYSIS | ||
| 1 | Physical Form | Crystalline Powder |
| 2 | Colour | Yellow |
| 3 | Odour | Odourless or Almost Odourless |
| 4 | Solubility | Slightly soluble in water, chloroform and ethanol |
| 5 | pH | 4.5 to 7.0 at 20°C to 25°C |
| 6 | Loss on Drying | Not more than 0.5% |
CHEMICAL ANALYSIS
| SR. No. | TESTS | SPECIFICATIONS |
| CHEMICAL ANALYSIS | ||
| 1 | Identification of Furazolidone examination by IR spectrum | Should comply the standard spectrum |
| 2 | Identification Test of Furazolidone | Deep Blue color should produce |
| 3 | Contents of Furazolidone | 97 to 103% OAB |
6.0 SAMPLING
Refer to the Incoming SOPs for sampling (SOPs)
7.0 REJECTIONS:
7.1 If the Furazolidone does not satisfy the specifications mentioned in 5.0 then it will be rejected. In addition to the specifications, Furazolidone is also rejected due to the following reasons:
7.2 If the receiving raw material is cross contaminated due to any reason.
7.3 The material does not bear 75% of its stated shelf life at the time of receipt.
8.0 PACKAGING
Furazolidone is received in polyethylene bag placed in sturdy, cardboard container to protect it from moisture and light.
9.0 STORAGE: BP
Store the container protected from light.
10.0 HANDLING
10.1 Use gloves & mask during weighing and dispensing operation of Furazolidone.
10.2 Keep the container of Furazolidone well closed immediately after use.
10.3 Place the container of Furazolidone back to its specified area.
ANALYSIS
11.1 (A) Suitable Machinery/Equipment/Apparatus
PHYSICAL
- Beaker
- Glass Rod
- Test Tube
- pH Meter
- Moisture Balance
CHEMICAL
- Test Tubes
- Volumetric Flask 100 ml, 500 ml
- Graduated Pipette 5 ml
- Titration Flask 100 ml
- U.V. Spectrophotometer
- Analytical Balance
- Magnetic Stirrer
- Spatula
- FTIR, mortar & pestle
List Of Reagent/Chemical
- Ethanol 96 % 10 ml
- Chloroform 10 ml
- Potassium bromide IR grade 200 mg
- Dimethylformamide 150 ml
- 1 M Ethanolic Potassium Hydroxide 1 ml
11.2 PHYSICAL ANALYSIS USP/BP
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 yellow.
11.2.3 Test of Odour:
Check the odour of the sample; it should be odourless or almost odourless.
11.2.4 Test of Solubility:
Check the solubility of the sample in water, ethanol and Chloroform.
It should be slightly soluble in water, chloroform and ethanol.
11.2.5 Test of pH:
Weigh accurately on analytical balance 5 mg of sample and make the volume upto 100 ml with distilled water. Take 50 ml from the resulting solution and measure the pH of solution at 20°C to 25°C on pH meter; it should be 4.5 to 7.0 at 20°C to 25,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%.
11.3 Record the result of Physical Analysis on quality report.
11.4 CHEMICAL ANALYSIS: USP/BP
11.4.1 Examination of Furazolidone by IR spectrum:
Take dried sample to 5mg of Furazolidone 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 Furazolidone:
Dissolve 1mg in 1ml of dimethylformamide and add 0.05ml of IM ethanolic potassium hydroxide. A deep blue colour is produced.
11.4.3 Contents of Furazolidone:
Carryout the assay procedure protected from light.
11.4.3.1 Sample Preparation:
11.4.3.1.1 Weigh accurately on analytical balance 100 mg of the powdered sample of Furazolidone, add 150ml dimethylformamidae, swirl to dissolve and make the volume upto 500 ml with water in the volumetric flask.
11.4.3.1.2 Take 5 ml from the step 11.4.3.1.1 and make the volume upto 100 ml with distilled water in the volumetric flask, mix and filter it in 100 ml titration flask.
11.4.3.1.3 Measure the absorption of step 11.4.3.1.2 at 367 nm on U.V Spectrophotometer.
11.4.3.1.4 Value of E ( 1%,1cm ) is 750.
11.4.3.2 Blank Preparation:
11.4.3.2.1 Take 1.5 ml of dimethylformamide, make the volume upto 100 ml with distilled water and filter it in 100 ml titration flask.
11.4.3.2.2 Measure the absorption of step 11.4.3.2.1 at 367 nm on U.V Spectrophotometer.
11.4.3.2.3 Value of E (1%,1cm ) is 750.
11.4.3.3 Observation:
a) Absorption of Sample Preparation = A
b) Record the reading.
11.4.3.4 Calculations:
11.4.3.4.1 Calculate the contents of Furazolidone as follows:
A
——————————— x 100 = B
750
Limit: The contents of Furazolidone should be between 97-103%. OAB
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