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