IS THERE ANYWHERE MENTION THAT THE RE PROCESS BATCH REQUIRE
TO KEPT STABILITY STYDY
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 |
In Agilent HPLC calibration using Empower 3 Software, What is the criteria for GPV Baseline starting point? i.e., Either it can start from -0.00/+0.00 or any range is there like -0.05 to +0.05 or ......etc?
In GC calibration,what is the procedure to calibrate the TCD (thermal counductivity detector)suggest ?
what is concentration of oxygen in U.H.P. grade N2 cylinder
Many times I don't got a caffeine peak in calibration of hplc using guard column ❓
How can you prepare 0.1% Phosphate buffer solution?
Which detector is used in uv-vis spectrophotometer?
HOW RRF IS CALCULATED IN HPLC
Retention time & Relative Retention time Definition & between difference? How to Calculate response factor(RF) & relative response factor(RRF)?
what is difference between polarity and dipolemoment
India is. Under which zone as per QF1.?
4 Answers Acebright, Aurobindo, Gland Pharma,
how can u seperate polar compounds in hplc ?
1 Answers Meditab, Piramal Healthcare,
calibrtion procedue of LC-MS