what is the limit of Correlation for IR test compare to the
standard and test
Answers were Sorted based on User's Feedback
Answer / kvb murthy
NLT 0.95 for Inetrmediates
NLT 0.99 for Active Pharmacuetical Ingredients
| Is This Answer Correct ? | 5 Yes | 1 No |
Answer / ch ankammarao
NLT-0.95 for intermediate
NLT-.0.99 for Final approval products
| Is This Answer Correct ? | 1 Yes | 0 No |
Answer / guest
NLT:0.95FOR INTERMEDEATES AND NMT
:0.98FOR FINAL APIS
| Is This Answer Correct ? | 5 Yes | 6 No |
stability study is going on up to 3years for famotidine-USP but the pharmacopeia is revised and tlc test is replaced with hplc test. At the 4th year frequency the product is failed in hplc test .how can i assain the expiry or retest date and can i stop or continue the programme?
in dissolution why pool sample needed? in which type of drug pool sample need?
[3/28, 20:52] Manoj P Venkatpurwar: how many impurities require to inject in assay specificity that how we can find out? and in Rs also how?
what is the difference between BDS and ODS Columens and both are same or not
2 Answers Intas, IPQA, Micro Labs, Vasava Engineering Private Limited,
Which Pharmacopiea follow calibration of HPLC,GC
full name of OOS & OOT ? Dercribe it with details ? why this is needed in pharma industry ?
What is mean by peak tailing in case of GC?
In case of dissolution test, if there is variation within 6 individual units however the batch is complying as per S1 criteria, is it necessary to do investigation for the same? What should be the criteria for such variation?
how require to select dissolution media? what is discrimination?
WHAT IS THE PARAMETER FOR THE SELECTION OF MOBILE PHASE IN HPLC?
How require to perform linearity as per ANVISA? What are the acceptance criteria?
What is calibration procedure of gredient HPLC pump