In Analytical method development related substance method when did follow w/w method when did follow area normalisation method
Answers were Sorted based on User's Feedback
Answer / d.thirupathi
if the method dont have known impurities we can choose the
area normalisation method.if known impurites is present we
can go for w/w method
Is This Answer Correct ? | 14 Yes | 3 No |
Answer / parag
we can go with area normalisation method when the RRF of
the impurities are 1 or during the Drug-Excipient
Compatibility study when the amount of drug added in the
sample not exactly known concentration.
Is This Answer Correct ? | 4 Yes | 2 No |
Answer / tukaram masal
When response of main peak is linear from LOQ to nominal
test concentration then area normalisation method for
related substances and When response of main peak is not
linear from LOQ to nominal test concentration then w/w
method for related substances.
Is This Answer Correct ? | 3 Yes | 3 No |
Answer / raghavender
impurites are not avaliable follo are normalization method &
other cases fololow w/w method
Is This Answer Correct ? | 3 Yes | 4 No |
Answer / naga
when all impurities RRF values between 0.95 to 1.05 we can
go for area normalisation method
Is This Answer Correct ? | 3 Yes | 4 No |
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