How do you fix the known and unknown impurity limit for a drug substance?

Answer Posted / chakravarthy

The limits for a known impurity shall be fixed based on the
toxicology data of the impurity and the dosage of the drg
product, where as for the unknown impurity is based on the
dosage of the product.

Is This Answer Correct ?    26 Yes 2 No



Post New Answer       View All Answers


Please Help Members By Posting Answers For Below Questions

Hi Sir?Mam, If i complete SAS CLINICAL in India, can i step forward to USA for job trials? How far is it possible? Am a B.pharm student ,willing to make up my Master's degree too,will this both M.Pharm and SAS help me out to get a job in USA? Please help me out with a good answer.

1683


why didn't you go back to previous employer after shifting to bangalore?

1725


Iam a B.PHARMA GRADUATE from DELHI UNIVERSITY and I am looking forward for DRUG INSPECTOR EXAM..kindly mail me any ques papaers reg the same...

1732


What interests you about the position of Medical Librarian in our company?

2093


What r the different sop in or plant

1518






Explain difference between sonication and homozinization?

656


what is factor?

1746


How to perform forced degradation on tablet sample or suspensions?

621


What is forced degradation study?

742


pls send me last two years solved papers of health & malaria inspector to kumar.santosh087@yahoo.com

1554


What was your most difficult experience with this population and how did you deal with it?

1645


Can any one tell me that which brand hplc column is used for levetiracetam imp- b test.

1385


What are the regulatory commitments in markets like USA, Canada, Europe, Brazil, South Africa and Japan

1924


please explain the job responsibilities of quality assurance..

1865


How are you qualified for the position of Assistant Clinical Director?

1970