How to develop the method when we have very low amount of
impurity?
Answers were Sorted based on User's Feedback
Answer / kalpana
by doing the force degradation of the sample in different
condition(like acid, alkali, peroxide,thermal and
photolytic degradation)and then develope the method.
Is This Answer Correct ? | 13 Yes | 2 No |
Answer / balaji
IN THIS CASE INCRESE SAMPLE CONCENTRATION EG; MY DRUG KNOW
IMPURITES LIMIT IS 0.05% UNKNOW IMP LIMIT IS 0.03% INTHIS
CASE STD PREPARATION IS 5MG/100 FURATHER 1/100 THIS IS KNOW
IMPURITES CONCENTRATION 3/100 AND 1/100 THIS UNKNOW IMP
MEANS API, SAMPLE CONCENTRATION IS 1MG/ML IF STD AREA IS
NOT COME INCRESE THE SAMLE CONCENTRTION MEANS
10/100*1/100*10/20*100=0.05% SAMLE CONCENTRATION IS 2MG/ML
Is This Answer Correct ? | 1 Yes | 3 No |
During Validation study, Recovery is passing at all levels but Linearity is failing. Justify?
1 Answers Mylan, Torrent Pharma,
what is dissolution What is unit of KF? what is the significant of pH in HPlc? WHY POTASSIUM HYDROGEN PTHALATE IS USED FOR PERCHLORIC ACID? What is difference btw UV detector & RID detector?
what is mean by assay?
What is Stray light ? & what is the IMP of this
IN pH CALIBRATION,CALIBRATION IS DONE FOR pH METER OR ELECTRODE?HOW WILL YOU JUDGE THAT THE METER TO BE CALIBRATED WITH 4,7,9.2 BUFFERS?EXPLAIN TEMPERATURE EFFECTS ON pH.
Near infrared Principle
can i use hplc detector to uplc and why?
Why pH range is maximum 14.0
who is the father modern liqiud chromatogrphy?
3 Answers Amneal Pharmaceuticals, Car Chem, Cipla,
difference between calibration and validation
What is the calibration of uv process and preparation
Difference between standard operating procedure and standard test procedures in pharmaceutical industry