Long Acting Animal Health Drug Products by Michael J. Rathbone & Arlene McDowell

Author:Michael J. Rathbone & Arlene McDowell
Language: eng
Format: epub
Publisher: Springer US, Boston, MA

Class 2: Solvents to be limited: Class 2 solvents are nongenotoxic animal carcinogens or possible causative agents of other irreversible toxicity such as neurotoxicity or teratogenicity. This category also includes solvents suspected of other significant but reversible toxicities. Examples include acetonitrile, hexane, toluene, and xylene. Permissible levels are low, and the manufacturer has several options for control of Class 2 solvents including complying with the concentration (ppm) limits in the guideline for each active and raw material in the formulation, complying with the guideline’s permitted daily exposure (PDE) requirements for the whole drug product, or justifying higher limits based upon considerations such as toxicological data, route of administration, dosing regimen, etc.

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