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What are the limits for uniformity dosage content for tablets and capsules
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Answer / viswanadham.dama
Uniformity of dosage units are determined from two ways.
1.Content Uniformity
2.Weight variation
Content Uniformity is applied when tablet or capsules having
25mg or below and
when active pharmaceutical ingradient 25% weight present in
the total tablet weight.
weight variation test is versa.
Acceptance critiria for uniformity of Dosage units are for
content uniformity Acceptance value cannot be more than 15.
calculation of acceptance value is
A.V=(X-M)+K.S
where X=Mean value of 10 units
M=98.5 or 101.5
K=2.4(constant value) for 10 units
2.0(constant value) for 30 units
S=Standard Deviation value
in the above expression there are three cases
a)A.V=K.S(when X value lies 98.5 to 101.5)
b)A.V=(X-M)+K.S(when X value is more than 101.5)
c)A.V=(M-X)+K.S(when X value is less than 101.5)
| Is This Answer Correct ? | 34 Yes | 13 No |
Answer / pandey
AV must be 15 in L1 as well L2 stage
While range for individuals unit are change in case L2
| Is This Answer Correct ? | 4 Yes | 1 No |
for 10 units (L1) A.V not more than 15
fro 30 units (L2) A.V not morw than 25
| Is This Answer Correct ? | 5 Yes | 7 No |
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