Although the official compendia define a drug substance as to identity, purity, strength, and quality, they normally do not provide other physical or chemical data, nor do they list methods of synthesis or pathways of physical or biological degradation and metabolism. Such information is scattered throughout the scientific literature and the files of pharmaceutical laboratories. Edited by the Associate Director of Analytical Research and Development for the AmericanAssociation of Pharmaceutical Scientists, Analytical Profiles of Drug Substances and Excipients brings this information together into one source. The scope of the series has recently been expanded to include profiles of excipient materials.

Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodology related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients. - Presents comprehensive reviews covering all aspects of drug development and formulation of drugs - Profiles creatine monohydrate and fexofenadine hydrochloride, as well as five others - Meets the information needs of the drug development community

Although the official compendia define a drug substance as to identity, purit strength, and quality, they normally do not provide other physical or chemic data, nor do they list methods of synthesis or pathways of physical or biological degradation and metablism. This is the 17th annual volume to p

Intended for medicinal, pharmaceutical and analytical chemists, this book brings together information detailing physical and chemical data defining a drug, and various methods of synthesis of biological/physical degradation and metabolism.

The Handbook of Forensic Drug Analysis is a comprehensive chemical and analytic reference for the forensic analysis of illicit drugs. With chapters written by leading researchers in the field, the book provides in-depth, up-to-date methods and results of forensic drug analyses. This Handbook discusses various forms of the drug as well as the origin and nature of samples. It explains how to perform various tests, the use of best practices, and the analysis of results. Numerous forensic and chemical analytic techniques are covered including immunoassay, gas chromatography, and mass spectrometry. Topics range from the use of immunoassay technologies for drugs-of-abuse testing, to methods of forensic analysis for cannabis, hallucinogens, cocaine, opioids, and amphetamine. The book also looks at synthetic methods and law enforcement concerns regarding the manufacture of illicit drugs, with an emphasis on clandestine methamphetamine production. This Handbook should serve as a widely used reference for forensic scientists, toxicologists, pharmacologists, drug companies, and professionals working in toxicology testing labs, libraries, and poison control centers. It may also be used by chemists, physicians and those in legal and regulatory professions, and students of graduate courses in forensic science. - Contributed to by leading scientists from around the world - The only analysis book dedicated to illicit drugs of abuse - Comprehensive coverage of sampling methods and various forms of analysis

This book examines genotoxic impurities and their impact on the pharmaceutical industry. Specific sections examine this from both a toxicological and analytical perspective. Within these sections, the book defines appropriate strategies to both assess and ultimately control genotoxic impurities, thus aiding the reader to develop effective control measures. An opening section covers the development of guidelines and the threshold of toxicological concern (TTC) and is followed by a section on safety aspects, including safety tests in vivo and vitro, and data interpretation. The second section addresses the risk posed by genotoxic impurities from outside sources and from mutagens within DNA. In the final section, the book deals with the quality perspective of genotoxic impurities focused on two critical aspects, the first being the analysis and the second how to practically evaluate the impurities.

The aim of this book is to present a range of analytical methods that can be used in formulation design and development and focus on how these systems can be applied to understand formulation components and the dosage form these build. To effectively design and exploit drug delivery systems, the underlying characteristic of a dosage form must be understood--from the characteristics of the individual formulation components, to how they act and interact within the formulation, and finally, to how this formulation responds in different biological environments. To achieve this, there is a wide range of analytical techniques that can be adopted to understand and elucidate the mechanics of drug delivery and drug formulation. Such methods include e.g. spectroscopic analysis, diffractometric analysis, thermal investigations, surface analytical techniques, particle size analysis, rheological techniques, methods to characterize drug stability and release, and biological analysis in appropriate cell and animal models. Whilst each of these methods can encompass a full research area in their own right, formulation scientists must be able to effectively apply these methods to the delivery system they are considering. The information in this book is designed to support researchers in their ability to fully characterize and analyze a range of delivery systems, using an appropriate selection of analytical techniques. Due to its consideration of regulatory approval, this book will also be suitable for industrial researchers both at early stage up to pre-clinical research.

This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.