Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective. The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment. The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination. Readers will also benefit from the inclusion of: A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents Perfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control.

"This publication represents the views and expert opinions of an IARC Working Group on the Evaluation of Carcinogenic Risk to Humans, which met in Lyon, 8-15 October 2013."

This volume of the IARC Monographs provides evaluations of the carcinogenicity of pentachlorophenol, 2,4,6-trichlorophenol, 3,3',4,4'-tetrachloroazobenzene, aldrin, and dieldrin. Pentachlorophenol, aldrin, and dieldrin are classified as persistent organic pollutants under the Stockholm Convention. Pentachlorophenol has been widely used as a wood preservative and insecticide, but its production and use are now restricted. 2,4,6-Trichlorophenol has also been used as a wood preservative and insecticide, and in the synthesis of some fungicides. Aldrin and dieldrin are synthetic organochlorine pesticides used as broad-spectrum soil insecticides for the protection of various food crops, as seed dressings, and to control infestations of pests such as ants and termites. In several countries their use has been banned or severely restricted since the early 1970s. 3,3',4,4'-Tetrachloroazobenzene is not manufactured commercially but is formed during the production and degradation of chloroanilide herbicides such as propanil, linuron, and diuron. Exposure to all five agents considered may occur in the general population as well as in various occupational settings. An IARC Monographs Working Group reviewed epidemiological evidence, animal bioassays, and mechanistic and other relevant data to reach conclusions as to the carcinogenic hazard to humans of environmental or occupational exposure of these agents.

Does the identification number 60 indicate a toxic substance or a flammable solid, in the molten state at an elevated temperature? Does the identification number 1035 indicate ethane or butane? What is the difference between natural gas transmission pipelines and natural gas distribution pipelines? If you came upon an overturned truck on the highway that was leaking, would you be able to identify if it was hazardous and know what steps to take? Questions like these and more are answered in the Emergency Response Guidebook. Learn how to identify symbols for and vehicles carrying toxic, flammable, explosive, radioactive, or otherwise harmful substances and how to respond once an incident involving those substances has been identified. Always be prepared in situations that are unfamiliar and dangerous and know how to rectify them. Keeping this guide around at all times will ensure that, if you were to come upon a transportation situation involving hazardous substances or dangerous goods, you will be able to help keep others and yourself out of danger. With color-coded pages for quick and easy reference, this is the official manual used by first responders in the United States and Canada for transportation incidents involving dangerous goods or hazardous materials.