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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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Anyone have any idea when to conduct Uniformity of Weight (UOW) and when need to conduct Uniformity of Dosage Units (UOD) or when need both? I read BP it only said if average weight < or = 0.04g then just conduct UOD, no need UOW. Under UOD section, it doesnt say when need to conduct UOD but just said UOD got two type, one is Mass Variation (MV), another is Content Uniformity (CU) and under what conditions to conduct them. For USP, no UOW section, only got UOD section.
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