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?
If suppose 10 methods of dissolution given in pharmacopoeial for single content product then which method out of 10? or all 10 require to follow?
how decide the clining method and cleaning method validation require for this perticular products?
How to set analyticl specification for combination products?
