What are the limits for uniformity dosage content for tablets and capsules
Answers were Sorted based on User's Feedback
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 |
what is difference between IR lamp and polarimeter lamp
on saturation solubility study data how we can find out the bcs class of drug?
Why Methanol used in KF Titration?
Which type of column should i use to check the purity of high molecular weight protein using HPLC reverse phase column chromatography? Hi everyone. I wanna to check the purity of high molecular weight protein (collagen) with MW of ~130 kDa using a HPLC. I know C18
0 Answers Petronas, Shanghai Ocean University,
How to study genotoxicity of impurities in API?
Why chromic acid wash is not recommended by USP for glassware cleaning?
how to select short coloum and long coloumn for new molecule
what v define from IR & NMR spectroscopy ?
In rs method development when we are going area normalization method to dilute standard method?
Why irmoisture balance is used for corrugated box moisture testing
why the most API molecule are in the hydrochloride form?
how peak can be sharp in hplc when it is come flat
6 Answers Graviti Pharmaceuticals,