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

345

How to determine water content of bis tetrazole amine mono ammonium salt

2956

How we performed the force degradation for drug substance, is any specific guideline is available for each parameter(Acidic, basic, oxidation,heat)? what conditions you mentained for above parameters.

1783

in each media we require to use SLS? how to proceed?

285

What is intact assay method development.....?

1996

identification is for unknown? qualification for known? reporting for LOQ?

272

Which parameters require to do in tech transfer?

262

in monograph 7 imp are there but in vendor showing 5 imp do not req to include 2 imp for that what will be justification?

254

How they found 1mL of K.F reagent is equivalent to 5mg of water and if we change the composition of K.F reagent, is it can neutralize more amount of water?

1291

Why a1% value is used for some product ? What is the criteria for selection a1% value ?

1859

UV and PDA detector, which have less signal to noise ratio?

635

what is the extinction coefficient for Indomethacin or at 319nm wave length.

3509

could negative ions be produced by bombardment process in mass spectrometry?

1277

which batch require to use for analytical method validation?

322



1807