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?
how require to interprit the method precision data of hptlc?
in api coa contains only process impurities and in product coa contains degradation impurities?
Which are the diffrent grades of api in pharma?
In which situation we require to prepare the standard solution from sample in Related substance method?
Hi sir if any product monograph not given known impurities (may be 5 impurities) specifications then how we require to proceed for inhouse formulation?
how to decide for one product require water content or LOD?
Which parameters require to do in tech transfer?
which batch require to use for analytical method validation?
how we can identify the impurity is coming below loq at transfering site?
what is mean by 40 in the dissolution basket mesh size?
why require to add enzymes in capsules dissolution only? is it require to tablet also?
If we have 5 strength which is not dose proportinate and excipients also diffrent in each strength then how we can proceed for Force degradation? and excipient are same but not dose propotinate the how FD?
for inorganic molecules require to do RS, Assay and disso?
if identification threshold crosses the limits then what next step?