One Raw material failed assay test is there any chance for
failing purity of that material ?
Answers were Sorted based on User's Feedback
Answer / a b shah
assay means w/w analysis, and purity means how many pure our
substance we check. so if assay failed so we don't tell
purity also fail.
Is This Answer Correct ? | 15 Yes | 1 No |
Answer / kishor solanke (alkem)
It is not necessary that if the assay is failed then purity
also fail because,
Assay is quantative test which determines the strainght of
anlyte in sample w.r.t. standard comparison, while in the
purity is, the material with presence of other impurities
as on chart.If impurities may higher than their respective
then only the material fails w.r.t. to their specification.
Is This Answer Correct ? | 10 Yes | 1 No |
Answer / baburao koyyagura
If assay of one product fails means there need not to fail
purity of the compound. Assay of sample is with respect to
standard both are in equql concentration(w/w) where as
purity os sample is area normalisation( %).parcentaze of
main peak w.r.t to other impuries.
Is This Answer Correct ? | 5 Yes | 1 No |
For this question the answer is here. Assay is amount of analyte present in the given sample. If assay fails does not mean that it is impure. A sample with 90% w/w assay will still have 100% purity. Purity defines the impurities in it. The possibility to check would be if any weighing error otherwise perform Related substances test to check the number of impurities.
Then we can get clarity. In simple basis assay and purity are correlated. But if assay is less does not mean it is impure.
Is This Answer Correct ? | 1 Yes | 0 No |
Answer / brahmaiah
The definiion of Assay is estimation of quantity and
percentage purity in that given sample.so if assay failed
then definitly purity also failed.
Is This Answer Correct ? | 0 Yes | 4 No |
Answer / sathish
ASSAY and PURITY is also same.when assay comes lower value
impurity is present in that batch.So purity also comes
lower.
Is This Answer Correct ? | 6 Yes | 11 No |
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