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
- 6569 Views
- Nakoda Chemicals, I also Faced
- E-Mail Answers
Answers were Sorted based on User's Feedback
Answer / 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 |
Answer / satyakumarreddy
As per Sechudle-H every reprocessed batch stability must be conducted
| Is This Answer Correct ? | 2 Yes | 0 No |
What is the use of ELSD in HPLC?
As per USP what is RSD limit of volumteric solution of three replicate analysis
What is polymorphism?which type of compounds exhibits polymorphism?
what is the origin to prepare standard operating procedure
why results are variation in same samples analysis in gc and hplc ?
How can v calibrate ftir ? Plz explain me
WHAT IS DIFFERENCE BETWEEN RRT AND RRF IN HPLC
why use k2cr2o7 , kcl h2so4 in uv calibration
Why acetonitrile and water are used as extraction solvent when analysis melamine? I thought they are miscible and won't be able to separate...
What is Log p?
For LOD and LOQ determination which method is accurate? (slopemethod or s/n ratio method)
Which type of material analysis in GC using Theramal conditivity detector ?
Organic Chemistry 
