Transcription of h467i RESIDUAL SOLVENTS - USP-NF
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h467i RESIDUAL SOLVENTS - USP-NF
USP 30 Chemical Tests / h467i RESIDUAL SOLVENTS 1. h467i RESIDUAL SOLVENTS Class 2 RESIDUAL SOLVENTS : SOLVENTS to be Limited Nongenotoxic animal carcinogens or possible causative agents of other irreversible toxicity, such as neurotoxicity or teratoge- (Chapter under this new title to become of cial July 1, 2007) nicity. (Current chapter title is h467i Organic Volatile Impurities) SOLVENTS suspected of other signi cant but rever- sible toxicities. For pharmacopeial purposes, RESIDUAL SOLVENTS in pharmaceuticals Class 3 RESIDUAL SOLVENTS : SOLVENTS with Low Toxic Po- are de ned as organic volatile chemicals that are used or produced in tential the manufacture of drug substances or excipients, or in the SOLVENTS with low toxic potential to humans; no preparation of drug products.
methylpyrrolidone, and sulfolane. Other appropriate validated procedures are to be employed for the quantification of these residual solvents. Such procedures shall be submitted to the USP for review and possible inclusion in the relevant individual monograph.] Table 2. Class 2 Residual Solvents Solvent PDE (mg/day) Concentration Limit (ppm)
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