Pirfenidone 267 mg Tablet Testing with UV Method is a common method used to determine the presence and concentration of Pirfenidone in the tablet. The UV method relies on the absorption of light by the active ingredient, Pirfenidone, at a specific wavelength. SOP for Pirfenidone 267 mg tablet Tablet Testing with UV Method testing is done as per the SOP for Pirfenidone 267 mg Tablet Testing with UV Method.

In addition to the UV method, other tests like physical tests (appearance, weight variation, disintegration, and hardness), and chemical tests (pH, assay, and impurities) are also performed to ensure the quality of the tablets.

Overall, Pirfenidone 267 mg Tablet Testing with UV Method is an important part of quality control in the pharmaceutical industry to ensure that the tablets are safe, effective, and meet the required standards.

PURPOSE:

To describe the procedure for analysis at in-process and finished stage of Pirfenidone 267 mg Tablet.

SCOPE:

This SAP gives a detailed outline for the finished product analysis of Pirfenidone 267 mg tablet and will cover In process testing activities on a physical, chemical & instrumental basis.

RESPONSIBILITY:

QC Analyst is responsible for physical/chemical testing and preparing standard analytical procedures.
It is the responsibility of the QC Manager to assist and ensure the Testing Procedure as per SAP and to make certain that this SAP is followed in its entirety, reviewed regularly, and revised as necessary.

REFERENCE:

INNOVATORS SPECIFICATIONS

MATERIAL AND EQIUPMENT:

• UV Spectrophotometer
• Dissolution apparatus
• Friability apparatus
• Hardness apparatus
• Disintegration Tester
• Vernier Caliper
• Analytical Balance
• Moisture analyzer
• Mortar and pestle
• Spatula
• Filter Paper
• Magnetic Stirrer & Hot Plate
• Sonicator
• Vacuum Pump
• Glassware
• Water

PROCEDURE:

FINAL MIX

Description:

White powder.

Procedure: Take 2.0 g of the test sample in a watch glass and observe visually with black background. Check the appearance of color, nature and any visible foreign particles.

Identification:

SOP for Pirfenidone 267 mg tablet Tablet Testing with UV Method

The spectrum of the sample preparation corresponds to spectrum of the standard preparation as obtained in the assay.

Assay: (Limit: 90%-110%)Compression Weight of Powder/Tablet: 340 mg /tablet

Procedure:

Standard Solution:

Take 66.7 mg of Pirfenidone WS dissolved in water and make up the volume to 100mL with water. Shake, and sonicate for 5 minutes to facilitate dissolution

Take 2 mL from standard stock solution and make up the volume to 50 mL with water

Sample solution:

Take weight of grinded powder equivalent to 133.5mg of Pirfenidone and dissolved in water and make up the volume to 200mL with water. Sonicate for 5 minutes, shake by mechanical mean for 10 minutes to disperse and allow any insoluble matter to settle.

Pass a portion of the sample stock solution through a suitable filter of 0.45um pore size.

Transfer the 2 mL of filtrate to a 50mL volumetric flask make up volume with water. Take reading at UV spectrophotometer at 312 nm using water as blank.

Calculations:

Sample Absorbance x Standard Concentration x Ave. Weight of Tablet x Potency
Standard Absorbance x Sample Concentration x Label Claim

Limit: Pirfenidone: 90%-110%of the labeled amount

Dissolution Test:

USP Apparatus: USP Apparatus II Paddle
Medium: 1000mL water
Speed: 50 rpm
Time: 30 Minutes
Medium Temperature: 37º ± 0.5º
Recommended Sampling Time: Pirfenidone: 30 Minutes
Diluent: Dissolution medium

Standard solution: Take 26.7 mg Pirfenidone WS in 100mL volumetric flask then make up volume with water.
Take 2 mL from standard stock solution and make up the volume up to 25 mL with medium.

Sample solution: Pass a portion of solution under through a suitable filter of 0.45-um pore size. Take 2 mL from filtrate and make up the volume up to 25 mL with medium.

Instrumental Conditions
Mode: UV
Analytical wavelength: UV 312 nm
Blank: Medium

Calculations:
Sample Absorbance x Standard Concentration x Potency
Standard Absorbance x Sample Concentration

Tolerance:
The amount of drug dissolve in solution for each tablet is not less Than 80% of the amount stated on the label for Pirfenidone at 30 minutes.

Uniformity of Dosage Units: (By Weight Variation)

Weigh 20 tablets individually and calculate the average weight as:
Average weight = (Weight Of 20 Tablets)/20

Weigh all these tablets individually and mark among these weights maximum (WMax) & minimum (WMin) weight tablets. Calculate the maximum and minimum variation in percent as:

Maximum% age variation =((WMax) – (WAvg.))/WAvg×100

Minimum % age variation ((WMin) – (WAvg.))/WAvg×100

Hardness Test & Dimensions:

Perform the hardness test on 10 tablets and take the average. Power on the instrument and regulate zero adjustment and preset the ‘’HARDNESS’’ and “Thickness” mode. Place the tablet on the test plate, begin testing and read the hardness thickness and diameter. Clean the shattered tablet and print out test results, perform the test on 10 tablets and take the average.

Friability Test:

For tablets with a unit mass equal to or less than 650 mg, take a sample of whole tablets corresponding to 6.5 g. For tablets with a unit mass of more than 650 mg, take a sample of 10 whole tablets. The tablets should be carefully dedusted prior to testing. Accurately weigh the tablet sample, and place the tablets in the drum. Rotate the drum 100 times, and remove the tablets. Remove any loose dust from the tablets as before, and accurately weigh. Generally, the test is run once. If obviously cracked, cleaved, or broken tablets are present in the tablet sample after tumbling, the sample fails the test. If the results are doubtful or if the weight loss is greater than the targeted value, the test should be repeated twice and the mean of the three tests determined. A maximum mean weight loss from the three samples of not more than 1.0% is considered acceptable for most products.
% FRIABILITY= W1-W2/W1 x 100

Disintegration Test:

Place the beaker filled with water into the beaker stand inside the bath and. Switch on the instrument, set the temperature at 37ºC± 2º C and wait till the temperature of the beaker reaches to the 37ºC± 2º C. Engage the basket on basket hook put the tablets in 6 tubes individually and place the discs then start the oscillations and timer. Note the disintegration time of all the six tablets.

Note the Disintegration time of 1st tablet to the last tablet.

Disintegration Time: NMT 15 minutes at 370C ± 20C

Acceptance criteria of disintegration for tablets:

If 1 or 2 tablets fail to disintegrate completely repeat the test on 12 additional tablets, not less than 16 of the totals of 18 tablets tested disintegrate completely.

Leak Test:

Take 06 blisters of tablet 03 filled and 03 empty. Dip these blisters in the bowl of leak test apparatus containing colored water. Create vacuum 250 mmHg and hold for one minute. Release vacuum and check the penetration of water inside the blisters. All blisters should be free of water.

CONTENT UNIFORMITY TEST: By Weight variation
Calculation of Acceptance Value (AV):

Limits:
L1= ≤ 15 (For 10 Unit)
L2= ≤ 25 (For 30 Unit)
General Formula = M-x̄ ±ks
Acceptability Constant = (k)
Standard Deviation (SD) = s
Number of Units = (n)
Reference Value = M
Mean of Individual Content = x̄