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Gold/Mining/Energy : Nuvo Research Inc

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To: Cal Gary who wrote (8729)	2/11/2002 1:13:46 PM
From: russet	Read Replies (2) of 14101

Cal,...they are talking about solvents used in the manufacturing process. DMSO less toxic, lower risk in acute and short term studies. They are talking about residual solvents in the drug after the drug is made. They are not talking about high concentrations as in Pennsaid, or long term exposure. Solvents in Class 3 (Table 3) may be regarded as less toxic and of lower risk to human health. Class 3 includes no solvent known as a human health hazard at levels normally accepted in pharmaceuticals. However, there are no long-term toxicity or carcinogenicity studies for many of the solvents in Class 3. Available data indicate that they are less toxic in acute or short-term studies and negative in genotoxicity studies. It is considered that amounts of these residual solvents of 50 mg per day or less (corresponding to 5,000 ppm or 0.5 percent under Option 1) would be acceptable without justification. Higher amounts may also be acceptable provided they are realistic in relation to manufacturing capability and good manufacturing practice (GMP).

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