What is the deference between Residual solvents and OVI
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Answer Posted / firoz ghanchi
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 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.
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