In terms of testing, the in-process stage of Rivaroxaban tablet testing would typically involve quality control measures to ensure that the tablets are being produced according to the intended specifications. This could include tests to check the tablet’s weight, thickness, hardness, and disintegration time. Rivaroxaban Tablet Testing HPLC and UV Method may also undergo testing for purity and content uniformity.
The finished stage of testing involves a series of quality control tests to ensure that the tablets meet the required standards for safety, efficacy, and quality before they are released for distribution. These tests could include identification tests, assay tests, dissolution tests, and impurity tests. The tablets may also undergo stability testing to ensure that they remain effective and safe throughout their shelf life.
To describes the procedure for analysis at in-process and finished stage of Rivaroxaban Tablet.
This SAP gives detailed outline for the finished product analysis of Rivaroxaban Tablet and will cover In process testing activities on a physical, chemical & instrumental basis.
QC Analyst is responsible for physical / chemical testing and preparing standard analytical procedures.
It is the responsibility of QC Manager to assist and ensure Testing Procedure as per SAP and to make certain that this SAP is followed in its entirety, reviewed regularly and revised as necessary.
MATERIAL AND EQIUPMENT:
- UV Spectrophotometer
- Dissolution apparatus
- Friability apparatus
- Hardness apparatus
- Disintegration Tester
- Vernier Caliper
- Analytical Balance
- Moisture analyzer
- Mortar and pestle
- Filter Paper
- Magnetic Stirrer & Hot Plate
- Vacuum Pump
- Methanol AR Grade
- Distilled water
FINAL MIX PROCEDURE BY UV:
A 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: (By UV SPECTROPHOTOMETER)
The spectrum of the sample preparation corresponds to spectrum of the standard preparation as obtained in the assay.
Loss on Drying: (By Moisture Analyzer)
Turn on instrument 20 minute before the test. Take 2 g powder spread uniformly on Moisture Analyzer plate. Close the lid and press start button.
NMT 5.0% when determined by LOD Apparatus, Use 2.0 g of powder.
Assay: (Limit: 90%-110%)Compression Weight of Powder/Tablet: 220 mg /tablet
Diluent: ACN : Water (50 : 50)
Take 20 mg of Rivaroxaban WS dissolved in 2.5mL of ACN and make up the volume to 100mL with diluent. 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 diluent.
Take compression weight of finally grinded granules eq to 20mg and dissolved in 2.5mL ACN and make up the volume to 100mL with diluent. 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 diluent. Take reading at UV spectrophotometer at 252 nm using diluent as blank.
Sample Absorbance x Standard Concentration x Ave. Weight of Tablet x Potency
Standard Absorbance x Sample Concentration x Label Claim x Factor
Limit: Rivaroxaban: 90%-110%of the labeled amount
USP Apparatus: USP Apparatus II Peddle
Medium: 900mL Acetate Buffer 4.5 with 0.4% Dodecylsulphate
Speed: 75 rpm
Time: 30 Minute
Medium Temperature: 37ºC ± 0.5ºC
Recommended Sampling Time: Rivaroxaban: 30 Minutes
Diluent: as per Assay
Standard solution: Take 41.7 mg Rivaroxaban WS in 50mL volumetric flask then make up volume with diluent.
Take 2mL from standard stock solution and make up the volume upto100 mL with medium.
Sample solution: Pass a portion of solution under through a suitable filter of 0.45-um pore size.
Analytical wavelength: UV 252 nm
Sample Absorbance x Standard Concentration x Potency
Standard Absorbance x Sample Concentration x Factor
The amount of drug dissolve in solution for each tablet is not less Than 80% of the amount stated on the label for Rivaroxaban at 45 minute.
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.
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
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.