How to establish pKa for a new API molecule ?
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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.
How can we calculate "confidence interval" in analytical method validation? Pl. explain with example.
what is the procedure for cleaning of lenses of hatr accesory of ftir instrument?
how decide the clining method and cleaning method validation require for this perticular products?
which batch require to use for analytical method validation?
for which product require to do content uniformity? what is limit of cu?
what is biorelivent dissolution media?
for inorganic molecules require to do RS, Assay and disso?
if you get peak in blank then what require to do?
What is control room temperature and which guide line says?
about method developement in hplc
what is %labelled amount in content uniformity of dosage unit and its calculation?
how can give the expiry period and restadardisation of volumetric solution
WHY given much noise PDA dector then VWD Dector
[3/30, 13:29] Manoj P Venkatpurwar: How hplc column selection according to structure? How mobile phase buffer selection on molecule structure?