Answer Posted / kishore
in organic materials
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Why acetonitrile and water are used as extraction solvent when analysis melamine? I thought they are miscible and won't be able to separate...
what is mean by 40 in the dissolution basket mesh size?
in dissolution why pool sample needed? in which type of drug pool sample need?
if you have given one product then how you determine the impurity in that?
using gradient pressure in gas chromatography are not ?using gradient pressure why
If change in specification which parameter require to do for validation? if change in chromtographic condition then which parameter? if api change then which parameter? if change composition then which parameter? if old method not work out then whicj parameter? if additional one impurity added then which parameter of validation require to do on above each conditions? elaborate separately
which are the diffrent batches in the pharmaceuticals?
what is partion and column chromatography
What is aggregate and fragments in SEC?
If combination product how require to identify which imp is of which api?
which batch require to use for analytical method validation?
In HPLC Calibration, On which basis RSD Limit of noise test is fixed (NMT 33.0 % )
In the HPLC Calibration done wavelength accuracy done between 200nm-280nm .but not done remaining 300-400nm not done ?
If vendor having more imp than monograph then how to proceed? and how to set spec?
