IS THERE ANYWHERE MENTION THAT THE RE PROCESS BATCH REQUIRE
TO KEPT STABILITY STYDY
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
What is the principle of HPLC, GC, LCMS, GCMS,LC QQQ, GC QQQ, LC Q TOF and GC Q TOF. What are the applications and Specificity?
1)What's the meaning of Absorption,give a example. 2)What's the meaning of Adsorption,give a example. 2)what is the difference between Absorption and Adsorption.
How doing qbd practically?
why we are using hexane in calibration of number of drop per mL
what is the difference between potentiometric titration and karl fischer titration?
Tell me something about Vitamin A test method by HPLC
in dissolution why pool sample needed? in which type of drug pool sample need?
IS THERE ANY EQUIPMENT TO CHECK AND CALCULATE THE POLARITY OF A LIQUID?
If we have 5 strength which is not dose proportinate and excipients also diffrent in each strength then how we can proceed for Force degradation? and excipient are same but not dose propotinate the how FD?
How to start the dissolution development for unknown tab?
iam usig ph buffers merk. manually how to prepare ?
why digestion require in icpms?
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?
what is %labelled amount in content uniformity of dosage unit and its calculation?
What is the acceptance criteria for moisture balance when calibrated with sodium sulfate