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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



In Analytical method development related substance method when did follow w/w method when did follow..

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

In Analytical method development related substance method when did follow w/w method when did follow..

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

In Analytical method development related substance method when did follow w/w method when did follow..

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

In Analytical method development related substance method when did follow w/w method when did follow..

Answer / raghavender

impurites are not avaliable follo are normalization method &
other cases fololow w/w method

Is This Answer Correct ?    3 Yes 4 No

In Analytical method development related substance method when did follow w/w method when did follow..

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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