| It is a test for the uniformity of the weight of the tablets
Performed by weighing 20 tablets randomly selected from a batch and determining their average weight. | Weight Variation Test |
| Weight Variation Test Limits according to USP | 1 Weight of tablet 130 mg or less then %error = ±10%
2 Weight of tablet 130-324 mg then %error = ±7.5%
3 Weight of tablet 324 mg or more then %error = ±5% |
| Weight Variation Test, tablets pass USP test if: __ | 1 No more than 2 indiv tablets are outside the percentage limit
2 No tablet differs by more than 2x the percentage limit |
| Every tablet contains the amount of drug substances intended with LITTLE VARIATION among tablets WITHIN A BATCH | Content Uniformity |
| 1 For content uniformity test, representative sample of __ are selected and __ are assayed individually.
2 Nine of the 10 tablets must contain __
3 If one or more dosage units do not meet the criteria, the remaining __ tablets are assayed individually and none may fall outside __ range for the batch to be accepted | 1) 30 tablets, 10
2 Not less than 85% or more than 115% of the labeled drug content
3) 20 tablets,
Not less than 85% or more than 115% range |
| For a drug to be absorbed from a solid dosage form from oral administration, it must first be in solution, and the first step is the break up of the tablet, a process known as __ | Disintegration |
| Tablet disintegration provides drug particles with an INCREASED __ | Surface Area |
| A measure of time required under a set of conditions for a group of tablets to disintegrate into particles which will pass through a 10 mesh screen | Disintegration Test |
| Liquids used in Disintegration | 1 Water
2 Simulated gastric fluid (pH= 1.2 HCl)
3 Simulated Intestinal fluid (pH= 7.5, Phosphate buffer, +pancreatin enzyme + NaOH) |
| USP FOR UNCOATED TABLETS | 1) Disintegrate test for 6 TABLETS
2) if 1 or 2 fail to disintegrate within 30 mins, repeat the test for another 12 TABLETS
3 NOT LESS THAN 16 TABLETS must disintegrate completely
4 if MORE THAN 2 TABLETS FAIL to disintegrate,
BATCH REJECTED |
| USP FOR COATED TABLETS | 1 put tablet in distilled water for 5 mins (Remove coat)
2 Put tablet in WATER or HCL for 30 mins at 37C
3 if NOT DISINTEGRATE, put in INTESTINAL FLUID
4 If 1 or 2 fail to disintegrate, repeat on 12 TABETS
5) NLT 16 TABLETS from 18 must disintegrate, if 2 OR MORE did not,
BATCH REJECTED |
| USP FOR ENTERIC COATED TABLETS | 1 Put tablet in distilled water for 5MINS (remove coat)
2 PUT Gastric Fluid (0.1M HCl) for 1 HOUR
3 Then PUT Intestinal Fluid for 2 HOURS
4 IF 1 or 2 TABLETS FAIL, Repeat for another 12
16 tablets should disintegrate, if TWO OR MORE FAILS,
BATCH REJECTED |
| B.P. Method for Enteric Coated Tablets | 1 Put tablet in distilled water for 5MINS (remove coat)
2 PUT Gastric Fluid (0.1M HCl) for 2 HOURS
3 Then PUT Phosphate Buffer for 1 HOUR
4 IF 1 or 2 TABLETS FAIL, Repeat for another 12
16 tablets should disintegrate, if TWO OR MORE FAILS,
BATCH REJECTED |
