Interested to Buy Any Domain ? << Click Here >> for more details...
What are the limits for uniformity dosage content for tablets and capsules
- 5 Answers
- 22928 Views
- Micro Labs, I also Faced
- E-Mail Answers
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 differance between volatile and non volatile compound expalin by exaple
why we get only one peak in assay by hplc but in rs by hplc get more peaks
why do we use around only 60 mg of K2cr2o7 in the UV calibration -control of absorbance test?
In GC and HPLC ,how we can decide which of following method will be suitable or use for quantitation of chromatogram at the time of method development. 1.Area Normalisation 2.External standard method 3.Internal standard method
what is main use of primary standards in caliration
2 Answers Lee Pharma, Lupin, Nectar Lifesciences,
why we use caffeine for hplc calibration?
what is the defination of accuracy & presicion?
8 Answers Amneal Pharmaceuticals, GSK,
In the test for control of absorbance in UV calibration why do we use only potassium dichromate and what is purpose of taking a specified amount of 57.0-63.0mg?
8 Answers Aurobindo, Cipla, FDC,
What is the difference between high pressure gradient and low pressure gradient in hplc?
How will you convert a 6 Normal solution to 8 Normal solution?
How require to develop GC method? how to select diluent, GAS, column selection and other chromatographic conditions?
what is the d/f b/w normality and molarity and molality..?
Organic Chemistry 
