How do you fix the known and unknown impurity limit for a drug substance?
- 2 Answers
- 19141 Views
- IBM, I also Faced
- E-Mail Answers
Answers were Sorted based on User's Feedback
Answer / 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 |
Answer / haran
unknown inpurity leval in drug is fix by using ich
gidelines & fda gidelines
it is only to depending on human effecting leval in
dilution respectively also
so that all solvents classified as class-a,b,c depeding on
there poision effection to human
| Is This Answer Correct ? | 12 Yes | 2 No |
How to set impurity limits for Related substances test.
difference between RF and correction factor?
why an employee go for medical representative instead of quality?
what is meant by artwork review and handling procedure with an example?
Why SLS used as dissolution medium
What is the different between GMP & cGMP ?
why nitrogen charecter as a inert gas plz identified
What are your intentions towards the uplift of the hospital.
What is forced degradation study?
What is the Difference between Humidity and Relative Humidity ?
What is GMP, GLP?????????
when we connect the capacitor banks in series with the circuit? 2 144 pH is having unit?
Pharmacy 
