Study Set Content:
Solids in single-unit containers Multiple Components, solution freeze-dried in final container >25 mg and >25% and
WV and WV
Solids in single-unit containers Multiple Components,others >25 mg and >25% and
CU and CU
Developed to ensure the content consistency of active pharmaceutical ingredients (API) within a narrow range around the label cla
Content Uniformity
Tablets of 30 are selected from the batch, (blank) are assayed.
10
Met if the content of each of the 10 tablets is within the limits of (blank) of the average of the limits specified in the potency definition in the individual monograph
85 and 115%
For dosage units with >50mg AI or if the AI is greater than 50% of the dosage units
Weight Variation
Weight Variation Sample tablet:
: 20 tablets
Acceptance Criteria: NMT (blank) should exceed the limits
2 tabs
Acceptance Criteria: 1. NMT 2 tabs should exceed the limits 2. No unit should be twice greater than (blank)or twice smaller than the (blank)
UPL lower limit
Factors responsible for weight variation
• Flow Properties • Degree of Saturation
IP
10%
IP
85-324 % weight variation acceptable
7.5%
IP
>324 % weight variation acceptable
5%
USP
10%
USP 130-324 % weight variation acceptable (+ or -)
7.5%
USP 324 % weight variation acceptable (+ or -)
5%
This test is provided to determine whether tablets or capsules disintegrate within the prescribed time when placed in a liquid medium under the experimental conditions presented below.
Disintegration Test
• For the purposes of this test disintegration does not imply complete dissolution of the unit or even of its active constituent
Disintegration Test
is a process in which tablets are break up into granules or smaller particles.
Disintegration
s defined as that state in which any residue of the unit, except fragments of insoluble coating or capsule shell, remaining on the screen of the test apparatus or adhering to the lower surface of the discs, if used, is a soft mass having no palpably firm core
Complete disintegration
