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
What are the filing requirements for ANDA-USA, Europe, Brazil, South Africa, Japan and Emerging Markets
What aspect of your communications skills have you improved the most in and how did you accomplish this improvement?
what is your experience in medical continuing education.
Tell us about your oncology experience.
while formulation of Gliclazide floating tablets why we are using direct cmpression technique why not wet granulation and what happend with that
How can I assign a retest date for solvents e.g. toluene, methanol, etc?
how many clauses are there in iso? give me the clauses details?
What is the basic requirement for preparing drug master file , like EDMF , USDMF ?
How to preform dissolution profiling
What is difference between Warm and Lukewarm Water as per pharmacopia.
Tell us about a situation in which you took the extra step for a patient.
how to calculate potency of working standard by using mass balence method & this calculated potency is on as basis or on anhydrous/ dried basis
How to do IR test of hydroscopic materials
What is forced degradation study?
What was your most difficult experience with this population and how did you deal with it?