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What is the difference b/w OVI Solvents and Residual
Solvents in case of Gas Chromatogaphy and What is its
Detection Limit?
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Answer Posted / k.praveen kumar
Residual Solvents in pharmaceuticals are Organic volatile
chemicals that are used or produced in the manufacture of
drug substance or excipient or in the preparation of drug
product.
Residual solvents refer to the amount not removed during
the purification of the drug product.
Organic Volatile Impurities <467>
1.Proposed in PF 14(2) (1988)
2.Incorporated into 3rdSupplement to USP 22(1990)
3.Acceptance criteria based on relative toxicity.
now the new name is Residual solvents <467>
Organic Volatile impurities are
1.Dichloromethane(600ppm)
2.Chloroform(60ppm)
3.Trichloroethylene(80ppm)
4.1,4-Dioxane(380ppm)
these four solvents are OVI solvents
Remaining solvents are residual solvents.
These are classified into 4 classes
Class 1 Solvents are 5
Class 1 Solvents are 27
Class 1 Solvents are 27
but class 4 solvents not having toxicological data.
there are 5 Solvents
detection limit is very low.
| Is This Answer Correct ? | 37 Yes | 13 No |
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