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Winpoj Posted 17 years ago
Medical & Dental Studies
Unqualified impurity
Would you know, at least in general terms, what the term "unqualified impurity" may mean in the context of medicinal products?
I've found it in this sentence:
"The change does not result from unexpected events arising during manufacture e.g. new unqualified impurity; change in total impurity limits."
It describes a condition for granting a change to marketing authorisation of a drug.
I've found it in this sentence:
"The change does not result from unexpected events arising during manufacture e.g. new unqualified impurity; change in total impurity limits."
It describes a condition for granting a change to marketing authorisation of a drug.
Top answer
This is a tough technical question. Here is the answer I found: Qualified here means that the impurities have to be established as safe at or above the levels present in a drug substance or product. Toxicological Sciences, Volume 100, Number 1 , Pp.
- This is a tough technical question.
- Here is the answer I found: Qualified here means that the impurities have to be established as safe at or above the levels present in a drug substance or product.
- Toxicological Sciences, Volume 100, Number 1 , Pp.
- 24-28 So, "unqualified" means that the impurities do not have an established safe level.
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1 Answers
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This is a tough technical question. Here is the answer I found:
Qualified here means that the impurities have to be established as safe at or above the levels present in a drug substance or product.
Qualified here means that the impurities have to be established as safe at or above the levels present in a drug substance or product.
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