Interested to Buy Any Domain ? << Click Here >> for more details...
IS THERE ANYWHERE MENTION THAT THE RE PROCESS BATCH REQUIRE
TO KEPT STABILITY STYDY
- 2 Answers
- 6595 Views
- Nakoda Chemicals, I also Faced
- E-Mail Answers
Answer Posted / ankur dwivedi
yes. It is mandatory to keep the re-processed batch for the
stability study as during the re-processing the impurity
levels can be changed and also polymorphic changes may be
possible if using other solvents. Its mentioned in GMP
practices. Nowadays it is one of the criteria from the
Regulatory Department. USFDA person can also ask for the
same. You should go through some good and standard GMP
reference books.
| Is This Answer Correct ? | 4 Yes | 0 No |
Post New Answer View All Answers
In HPLC Calibration, On which basis RSD Limit of noise test is fixed (NMT 33.0 % )
what is the importance of peak purity in HPLC and how we can calculate through manul(not software)?
what is mean by covalidation
Colorimtry
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 to start the dissolution development for unknown tab?
What is delay volume?
what is biorelivent dissolution media?
How to set specification of assay, fisdolution and related substances?
What is the diffrence in japan mkt requirement in analytical method validation over US?
How can I develope method of dissolution by HPLC OR UV
how the compound separate in coulunm,explain
Why Ethanol is Used for Standardization of GC Head space?
Is it nessesary all multimedia dissolution require descriminatory?
if you given one product then which tests you will perform?
