1.0) Description: Visual
2.0) Average Weight: Check weight of 20 tablets at random and calculate the average weight by formula.
Average weight (mg) = wt of 20 tablets (gm) x 1000
20
3.0) Uniformity of weight:
Weigh 20 tablets selected at random and calculate the average weight. Not more than two of the individual weights deviate from the average weight by more than the percentage shown in table.
Weigh the tablets individually and calculate the percentage of deviation for each tablet by using formula:
Deviation (%) = Weight of each tablet – Average weight x 100
Average weight
| Average weight of tablets | Percentage deviation |
| 250 mg or More | ±5% |
4.0) Identification Test:
In the assay the principal peaks in the chromatogram obtained with the test solution corresponds to the peaks in the chromatogram obtained with the reference solution.
5.0) Hardness:
The standard method used for tablet hardness testing is compression testing. The tablet is placed between two jaws that crush the tablet. The machine measures the force applied to the tablet and detects when it fractures.
6.0) Disintegration Time:
Unless otherwise stated in the individual monograph, introduce one tablet into each tube and add a disc to each tube. The assembly is suspended in the liquid medium in a suitable vessel, preferably a 1-litre beaker. The volume of liquid is such that the wire mesh at its highest point is at least 15 mm below the surface of the liquid, and at its lower point is at least 25 mm above the bottom of the beaker. At no time should the top of the basket-rack assembly become submerged. There is a thermostatic arrangement for heating the liquid and maintaining the temperature at 37±2°.
If 1 or 2 tablets fail to disintegrate, repeat the test on 12 additional tablets; not less than 16 of the total of 18 tablets tested disintegrate.
If the tablets adhere to the disc and the preparation under examination fails to comply, repeat the test omitting the disc. The preparation complies with the test if all the tablets in the repeat test disintegrate.
7.0) Dimension of Tablet:
Length, width and thickness are determined by vernier calliper in mm.
8.0) Leak test:
The apparatus is used to test for the integrity of packed strips, blisters and Alu-Alu Blister pack containing tablets. Ensure apparatus bath is filled with purified water upto mark indicated and add 0.5% crystal violet solution in water. Samples are placed into the desiccators and the lid is placed in position. The pump starts to produce a vacuum 15inHg inside the desiccators and the vacuum is held for 1 minute. The sample remains at the required vacuum level for given time interval buzzer will sound after time is over and will cut off the vacuum pump. As the package is immersed in a colored dye solution the venting of the desiccators will allow any holes to be penetrated by the dye and the contents of the flexible packaging will also be stained with the same coloring material.
Examine all the strips for any leakage by opening the pockets manually. If anyone pocket shows evidence of leakage, reject the sample, stop the Blister / Strip machine and immediately take corrective action.
10.0) Assay:
Tranexamic acid:
Chromatographic condition:
- Mobile phase: – Dissolve 11 gm of anhydrous sodium dihydrogen orthophosphate in 500 ml of water, add 5 ml of triethylamine and 1.4 gm of sodium dodecyl sulphate, adjusted to pH 2.5 with 2M orthophosphoric acid and dilute to 600 ml with water, add 400 ml of methanol.
- Column: C-18(250 x 4.6mm) 5µm,
- Wavelength: 220 nm,
- Flow rate: 9 ml per minute,
- Injection volume: 20µl,
Standard preparation: Weigh accurately about 100 mg of Tranexamic acid working standard in 100ml volumetric flask and dissolve in water and make up the volume with water. Take 5 ml of this solution in 25 ml volumetric flask and make up the volume up to the mark. And filter with 0.45µm nylon filter.
Test preparation: Same dilution as standard dilution. Shake well and filter through 0.45µm nylon filter.
Procedure:
Inject separately standard and test preparation. Inject five replicate injection of standard and two replicate injection of test preparation.RSD of replicate injection should not more than 2%. Calculate the assay of Tranexamic acid, by comparison to peak area of standard preparation.
Calculation: Tranexamic acid
Test area Std wt. 5 100 25
————-X———-X——-X———-X——-X Avg. Wt. X Potency of STD Std. area 100 25 test wt. 5
Mefenamic acid:
Chromatographic condition:
- Mobile phase: A mixture of 23 volumes of acetonitrile, 20 volumes of 0.05 M of monobasic ammonium phosphate adjusted to a pH 5 with 3 M ammonia and 7 volumes of tetrahydrofuron.
- Column: C-18 (250 x 4.6mm) 5µm,
- Wavelength: 254 nm,
- Flow rate: 1 ml per minute,
- Injection volume: 20µl,
Standard preparation: Weigh accurately about 20 mg of Mefenamic acid working standard in 100 ml volumetric flask and dissolve in mobile phase and make up the volume with mobile phase
Test preparation: Same dilution as standard dilution. Shake well and filter through 0.45µm nylon filter.
Procedure:
Inject separately standard and test preparation. Inject five replicate injection of standard and two replicate injection of test preparation. RSD of replicate injection should not more than 2%. Calculate the assay of Mefenamic acid, by comparison to peak area of standard preparation.
Calculation:
Test area STD wt. 100
Mefenamic acid ————–X————X———–X Avg. wt. X potency of STD
Std. area 100 Test wt.
Abbreviations:
Wt.: Weight
STD: Standard
mg: Milligram
ml: Millilitre
inHg: Inch of Mercury
RSD: Relative standard deviation
