Question { Cipla, 22058 }

why we wre doing linearity siudiec in hplc method validation

Answer

The question is why linearity in method validation ? In fact
, the linearity is to prove that the method is capable pf
producing the response linearly or proportionally to the
amount present the sample.

Question { Dr Reddys, 13801 }

Whya the need of Specificity to do in Analytical Method
Validation ?

Answer

The specificity of an analytical method is basically to

1) To prove the stability indicating ability of the method

2)To identify the possible degradation of the molecule

3)To determine the type of degradation the molecule is
susceptible to

4)To prove the mass balance

5)To know the various degradation path ways of molecule

Question { Dr Reddys, 15230 }

What is the formula for Tapdensity /

Answer

Tap density=Weight of the sample/Volume of the sample in the
cylinder

Question { Cipla, 24924 }

IN DISSOLUTION TEST S1AND S2 AND S3 CONDITIONS ALL ARE
FAILED THEN WHAT IS THE DESSICION U CAN TAKE

Answer

Record an OOS and close it as product behaviour

Question { Cipla, 24924 }

IN DISSOLUTION TEST S1AND S2 AND S3 CONDITIONS ALL ARE
FAILED THEN WHAT IS THE DESSICION U CAN TAKE

Answer

Gupta, WHEN PRODUCT IS NOT MEETING THE SPECIFICATION UPON
TESTING OF 24 UNITS ,IS IT REALLY REQUIRED TO CARRY OUT
ANALYSIS BY SECOND OFFICER?

Question { Cipla, 24924 }

IN DISSOLUTION TEST S1AND S2 AND S3 CONDITIONS ALL ARE
FAILED THEN WHAT IS THE DESSICION U CAN TAKE

Answer

Dear GUPTA, S2 AND S3 STAGE OF ANALYSIS WILL GENERALLY BE
DONE UPON THE FAILURE OF THE PRODUCT TO MEET S1 STAGE.HENCE
S2 OR S3 WILL GENERALLY BE PERFORMED THE NEXT DAY ,MAY BE
USING DIFFERENT LOT OF MEDIUM,APPARATUS ETC.HENCE THE REPEAT
ANALYSIS BY SECOND OFFICER DOES NOT ADD ANY VALUE .