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