1.0 PURPOSE
This Raw material Specification & Analysis prescribes the requirements for Vitamin-C (Ascorbic Acid) coated which is one of the components of Multivitamin Tablet.
2.0 SCOPE
It is applicable in Material, Product Development and Quality Assurance Department to confirm its physical & chemical specifications.
3.0 REFERENCE
BP/USP/In house
4.0 DEFINITIONS
Follow SOP
5.0 SPECIFICATIONS
BP/USP/In house
PHYSICAL ANALYSIS
- Physical Form: Crystalline Powder or colorless crystals
- Colour: White or almost white
- Odour: Odourless or Almost Odourless
- Solubility: Freely soluble in water and soluble in ethanol (96%) and insoluble in chloroform.
- pH: 2.1 to 2.6 at 20°C to 25°C
- Melting point: About 190°C with decomposition.
- Bulk Density: Should be between 0.800 – 0.850 g/ml.
- Tapped Density: Should be between 0.900 – 0.950 gm/ml.
CHEMICAL ANALYSIS
- Identification Test of Ascorbic Acid: Grey precipitate should produce.
- Contents of Vitamin C (Ascorbic Acid) coated: 99 to 100.5%
6.0 SAMPLING
Refer to the Incoming SOPs for sampling.
7.0 REJECTIONS:
If the Vitamin-C (Ascorbic Acid) coated does not satisfy the specifications mentioned in 5.0 it will be rejected. In addition to the specifications, Vitamin-C (Ascorbic Acid) coated 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
Vitamin-C (Ascorbic Acid) coated is received in polyethylene bag placed in metallic/cardboard container to protect it from moisture and light.
9.0 STORAGE: USP
Store in a tight, light-resistant container.
10.0 HANDLING
10.1 Use gloves & mask during weighing and dispensing operation of Vitamin-C (Ascorbic Acid) coated.
10.2 Keep the container of Vitamin-C (Ascorbic Acid) coated well closed immediately after use.
10.3 Place the container of Vitamin-C (Ascorbic Acid) coated back to its specified area.
11.0 ANALYSIS
11.1 (A) Suitable Machinery/Equipment/Apparatus
PHYSICAL
Beaker
Glass Rod
pH meter
CHEMICAL
Graduated Pipette 10 ml
Titration Flask 250 ml
Burette 25 ml
Analytical Balance
Spatula
Test Tubes
Chemicals
Conc. Nitric Acid: 2 ml
Ethanol 96%: 10 ml
Chloroform: 10 ml
Reagents
Dilute Sulphuric Acid 30 ml
Silver Nitrate TS 1 ml
0.1 N Iodine Solution 25 ml
Starch Solution 5ml
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 or colorless crystals.
11.2.2 Test of Colour:
Confirm the colour of the material by comparing with standard from colour chart; it should be white or almost white.
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 96% and in chloroform; It should be freely soluble in water and soluble in ethanol 96% and practically insoluble in chloroform.
11.2.5 Test of pH:
Weigh accurately on analytical balance 5 g of sample and make the volume upto 100ml with distilled water. Take 50 ml from the resulting solution and measure the pH of solution on pH meter; it should be 2.1 to 2.6 at 20°C to 25°C.
11.2.6 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 0.800 – 0.850 g/ml.
11.2.7 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 0.900 – 0.950 gm/ml.
11.3 Record the result of physical analysis on Quality Report.
11.4 CHEMICAL ANALYSIS: BP/USP
11.4.1 Identification Test of Vitamin-C (Ascorbic Acid):
Weigh accurately on analytical balance 50 mg of the sample, put it in test tube, add 5 ml of distilled water, 1 ml of Silver Nitrate TS and 0.5 ml of nitric acid; Grey precipitate should produce.
11.4.2 Contents of Vitamin-C (Ascorbic Acid):
11.4.2.1 Sample Preparation:
11.4.2.1.1 Weigh accurately on analytical balance 100 mg of the powdered sample of Vitamin-C (Ascorbic Acid) in 250 ml titration flask, add 30 ml dilute Sulphuric Acid and 100 ml of distilled water and heat it, cool it.
11.4.2.1.2 Titrate step 11.4.2.1.1 with the help of 25 ml burette with 0.1 N Iodine solution using Starch Solution as an indicator.
11.4.2.2 Observations:
a) Volume of 0.1 N Iodine solution used for sample = A
b) Record the reading.
11.4.2.3 Calculations:
Calculate the contents of Vitamin-C (Ascorbic Acid) as follows:
Factor: Each ml of 0.1 N Iodine solutions is equivalent to 8.806 mg of Vitamin-C (Ascorbic Acid).
8.806 x A
——————————– X 100 = B
100
Limit: The contents of Vitamin-C (Ascorbic Acid) coated should be between 99-100.5%.
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.