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If inhouse hplc related substance method is completly diffrent from Usp for finished proďuct with diffrent impurities then how require to prove method equivalecy?
817analytical method validation require to with respect to release specification or shelf life specification?
850in monograph 7 imp are there but in vendor showing 5 imp do not req to include 2 imp for that what will be justification?
786In which situation we require to prepare the standard solution from sample in Related substance method?
825Hi sir if any product monograph not given known impurities (may be 5 impurities) specifications then how we require to proceed for inhouse formulation?
757Post New Analytical Chemistry Questions
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 many types of balance calibration test?
WHAT IS THE USE OF STARTER ?????????
if rsd failed then what require to do?
Basic principle of ESI?
How require to perform linearity as per ANVISA? What are the acceptance criteria?
How to compare XRD graphs against standard and carry polymorpism study of API's by powder XRD method?
How can I develope method of dissolution by HPLC OR UV
in stress study if your api not soluble in hcl naoh h2o2 then what require to do?
sop of a uv visible spectrophotometer double beam elico model
What is the purpose of octyl silane columns?
What is the difference between purge septum flow and column flow in gas chromatography?
how you establish the LOQ?
What is the formula to determine the concentration of M of a solution given the % transmittance? Use %T = 43.7 as an example.
what is impurity profile. how to interpret this impurity profile to a drug product or drug substance.
