Study Set Content:
same for
uncoated tablets
Disintegration test ● Apparatus:
Basket rack assembly
Disintegration test
Runtime:
immerse 30 times per minute (depends on monograph)
Disintegration test
Temp:
thermostatically controlled fluid at 37 ± 1 C
Disintegration test
Pass if:
soft mass having no palpably firm core and only some fragments of the gelatin shell.
Dissolution test ● Apparatus:
Dissolution apparatus
Dissolution test
Runtime:
immerse 30 times per minute (depends on monograph)
Dissolution testTemp:
thermostatically controlled fluid at 37 ± 0.5 C
Dissolution test
Pass if:
NLT 85% of the labeled amount is dissolved in 30 minutes. usual conditions only
Weight variation capsules
1. Weigh the 10 original capsules individually 2. Separate the body from cap 3. Remove the powders completely 4. Subtract empty shell weight from original weight
weight variation gelatin
1. Weigh the 10 original capsules individually 2. Cut open each capsule and wash contents with a suitable solvent. 3. Evaporate the at room temp over ~30 minutes, with precautions to avoid uptake or loss of moisture. 4. Subtract empty shell weight from original weight
Content uniformity ● Pass if what percent of the label claim
85% to 115%
85% to 115% of the label claim for
9 of 10 dosage units assayed
if: 85% to 115% of the label claim for 9 of 10 dosage units assayed, with no unit outside the range of
70% to 125% of the label claim.
Additional tests are prescribed when (blank) are outside of the desired range but within the stated extremes
two or three dosage units
Semisolid DF to be applied topically
OINTMENTS, CREAMS, GELS
OINTMENTS, CREAMS, GELS can be
Medicated or non-medicated
Topical application can lead to local and systemic drug absorptions
OINTMENTS, CREAMS, GELS
designed to deliver drug into the skin in treating dermal disorders
Topical dermatologic product
designed to deliver drugs through the skin (percutaneous absorption) to the general circulation for systemic effect
Transdermal product
