Povidone (PVP) is a water-soluble polymer commonly used as a binder, dispersant, or viscosity enhancer in pharmaceuticals. SOP for Povidone (PVP) Raw Material Powder Testing of PVP RM powder typically involves verifying its physical characteristics (e.g. particle size, color, odor) and evaluating its chemical properties (e.g. assay, impurities, dissolution). These tests help to ensure the quality and consistency of the PVP RM powder, and can also help to identify any potential contaminants that might affect the product’s safety or efficacy. The specific tests performed will depend on the intended use of the PVP RM powder and may vary based on the manufacturer and regulatory requirements. A Standard Operating Procedure (SOP) is a written document that outlines the steps involved in a laboratory procedure. An SOP for testing Povidone (PVP) powder might include the following steps:

1. Sample collection: Collect a representative sample of the PVP powder for testing, SOP for Povidone (PVP) raw Material Powder Testing following established sampling procedures.
2. Physical Characteristics Testing: Test the PVP powder for physical characteristics such as particle size, color, and odor, using appropriate techniques such as sieve analysis, visual inspection, and organoleptic evaluation.
3. Chemical Characteristics Testing: Evaluate the chemical properties of the PVP powder, such as assay (purity), impurities, and dissolution, using appropriate analytical methods, such as HPLC, UV spectrophotometry, or dissolution testing.
4. Data Recording: Record all test results accurately and legibly, including any deviations from the SOP, in a laboratory notebook or electronic database.
5. Quality Control: Verify the accuracy and precision of the test results by performing appropriate quality control measures, such as duplicate or spiked sample analysis, or inter-laboratory comparison.
6. Report Generation: Generate a test report that summarizes the results of the PVP powder testing and includes a statement of compliance with established specifications or standards.

Purpose

To ensure the quality of incoming SOP for Povidone (PVP) raw Material Powder Testing.

Scope

It is applicable for the analysis of Povidone (PVP) Powder in the quality control department.

Responsibility

• Quality Control Manager
• Assist. Q.C. Manager
• Q.C Analyst

Abbreviations

1. SAP: Standard Analytical Procedure
2. QC: Quality control

Procedure

Equipment/Apparatus

• Analytical Balance
• Beaker
• Nesslar Cylinder
• Oven
• pH Meter
• Test Tube
• UV-Visible Spectrophotometer
• Volumetric Flask

Chemicals/Reagents

Chemicals

1. Acetone
2. Distilled Water
3. Ethanol (96%)
4. Methanol

Reagents

1. Titanium trichloride Sulphuric Acid reagent
2. Dilute Hyrdochloric acid
3. 1M Sulphuric Acid
4. 2M Hydrochloric Acid
5. Potassium Dichromate Solution R
6. 0.05M Iodine
7. Dimethylaminobenzaldehyde R
8. Acetate Buffer of pH 3.5
9. Thioacetamide Reagent
10. Reference solution B6

SOP for Povidone (PVP) raw Material Powder Testing

Physical Analysis

Test of Physical Form:

Check the sample and confirm its physical form; it should be Powder or flakes hygroscopic.

Test of Colour:

Confirm the colour of the material with naked eye; it should be white or yellowish white.

Test of Solubility:

Water: 1gm sample should be dissolved in less than 10 ml
Ethanol 96%: 1gm sample should be dissolved in less than 10 ml
Methanol: 1gm sample should be dissolved in less than 10 ml
Acetone: 20mg sample should be dissolved in 100 ml

Test of Appearance of solution:

1. Dissolve 5 gm of sample in water and make up the volume to 100 ml with the same solvent.
2. Fill Nessler cylinder of 15 – 20 mm in internal diameter to the depth of 40 mm with the solution.
3. Take the same type of Nessler cylinder and fill the with water upto 40 mm depth, this cylinder is taken as blank. Observe both cylinders against black background by viewing in diffused daylight down the vertical axis of cylinders.

Sample solution should be clear and the colour of the sample solution should be less intense than reference solution B6.

Test of pH:

Dissolve 5 gm of sample in water and make up the volume to 100 ml with water and measure the pH with the help of pH meter. That should be between 3.0 and 5.0.

Test of water contents:

Determine the water constants of the sample (Take 5g) by Karl Fischer Titrator.
It should not be more than 5.0 %

Limit Tests:

Peroxides:

Dissolve 2 gm in 50 ml of water. To 25 ml of this solution add 2 ml of titanium Trichloride Sulphuric Acid reagent R. allows to stand for 30 minutes. The absorbance of the solution, measured at 405 nm, using a mixing of 25 ml of 4% solution of the substance to be examined and 2 ml of a 13 % v/v solution of Sulphuric acid as the compensation liquid, is not greater than 0.35 (i.e. 400 ppm, expressed as peroxide).

Heavy Metals:

Sample Preparation:

1. Mix 2 gm of substance with 0.5 gm of magnesium oxide in a silica crucible.
2. Ignite to dull red heat until a homogeneous white or grayish white mass is produced. (If after 30 minutes of ignition the mixture remains coloured, allow to cool mix with fine glass rod and repeat ignition, if necessary repeat the operation)
3. Finally heat at 800oC for about one hour, dissolve the residue using two 5 ml quantities of 5M Hydrochloric Acid.
4. Add 0.1 ml of phenolphthalein solution and 13.5 M Ammonia drop wise until a pink colour is produced.
5. Cool and add glacial acetic acid until the solution is decolorized and add further 0.5 ml.
6. Filter if necessary and dilute the solution to 20 ml with distilled water.
7. To 12 ml of resulting solution add 2 ml of acetate buffer of 3.5 pH, mix and 1.2 ml of thioacetamide reagent.
8. Mix immediately and allow to stands for two minutes.

Standard Preparation:

1. Add 2 ml of lead 10 ppm standard solution to 0.5 gm of Magnesium Oxide present in a silica crucible.
2. Dry the mixtures in an oven at 100oC – 105oC, ignite as for sample.
3. Dissolve the residue using to 5 ml quantities of 5M Hydrochloric Acid.
4. Carry out the next process as described in sample in (step d to step h of sample preparation).

Blank:

Mix 2 ml of the solution obtained in (step d of sample preparation) for sample with 10 ml distilled water and treat in the same manner as for sample from (step e to step h of sample preparation).

Observation:

1. Any brown colour produced in sample in not more intense than standard.
2. The standard solution exhibits slightly brown colour when compared to blank.

Chemical Analysis:

Identification Tests of Povidone (PVP) Powder:

1. To 0.4 ml of (5%) sample solution add 10 ml of water, 5 ml of dilute Hydrochloric Acid and 2 ml of Potassium Dichromate solution, an orange yellow precipitate is formed.
2. To 0.1 ml of (5% w/v) solution of sample add 5 ml of water and 0.2 ml of 0.05 M iodine. A red colour is produced.
3. To 1 ml of solution S1 add 0.2 ml of dimethylaminobenzaldehyde solution R1 and 0.1 ml of sulphuric acid R. A pink colour is produced.

Quality Record(s)/Form(s):

The following Quality Records shall be generated and managed in accordance with the Procedure for Control of Company Quality Records.

Note: This SOP is intended to provide a general guideline and may need to be adapted based on the specific requirements of your laboratory and regulatory environment.