This book is a comprehensive compilation of modern and cutting-edge chromatographic techniques written by pharmaceutical industry experts, academics, and vendors in the field. This book is an inclusive guide to developing all chromatographic methods (such as liquid chromatography and gas chromatography). It covers modern techniques for developing methods using chromatographic development software, requirements for validations, discussion on orthogonality, and how to transfer methods from HPLC to UHPLC. The text introduces some newer techniques that are heavily employed by chemists analyzing proteins and RNAi, as well as novel techniques such as counter current chromatography. This book is valuable for both the novice starting out in undergraduate labs and those who are new to the pharmaceutical industry and is a useful reference for seasoned analysts.

Analytical chemists in the pharmaceutical industry are always looking for more-efficient techniques to meet the analytical challenges of today s pharmaceutical industry. One technique that has made steady advances in pharmaceutical analysis is supercritical fluid chromatography (SFC). SFC is meeting the chromatography needs of the industry by providing efficient and selective testing capabilities on the analytical and preparative scale. The supercritical fluid mobile phase, consisting mainly of CO2, facilitates cost reduction costs and helps the industry in meeting green chemistry standards. This book provides a comprehensive overview of the use of SFC in pharmaceutical analysis.

Supercritical Fluid Chromatography reviews the use of SFC in drug-discovery applications and describes its application in drug development. When a drug is developed and brought to market, it is tested many times for impurities and degradants, enantiomeric purity, and analytical and preparative isolations it is tested during discovery and development and for under-regulated and unregulated methodologies. The book describes the use of SFC for each of these applications and discusses more in-depth topics, such as the use of SFC in mass spectrometric and polarographic detection. The book also sheds light on the role of SFC in drug development from natural products and the advancement of SFC with new technologies and its use in pilot-scale operations as a chromatographic technique.

The accomplishments and enduring influence of renowned anthropologist Dell Hymes are showcased in these essays by leading practitioners in the field. Hymes (1927-2009) is arguably best known for his pioneering work in ethnopoetics, a studied approach to Native verbal art that elucidates cultural significance and aesthetic form. As these essays amply demonstrate, nearly six decades later ethnopoetics and Hymes's focus on narrative inequality and voice provide a still valuable critical lens for current research in anthropology and folklore. Through ethnopoetics, so much can be understood in diverse cultural settings and situations: gleaning the voices of individual Koryak storytellers and aesthetic sensibilities from century-old wax cylinder recordings; understanding the similarities and differences between Apache life stories told 58 years apart; how Navajo punning and an expressive device illuminate the work of a Navajo poet; decolonizing Western Mono and Yokuts stories by bringing to the surface the performances behind the texts written down by scholars long ago; and keenly appreciating the potency of language revitalization projects among First Nations communities in the Yukon and northwestern California. Fascinating and topical, these essays not only honor a legacy but also point the way forward.

This book is the first text to provide a comprehensive assessment of the application of fundamental principles of dissolution and drug release testing to poorly soluble compounds and formulations. Such drug products are, vis-a-vis their physical and chemical properties, inherently incompatible with aqueous dissolution. However, dissolution methods are required for product development and selection, as well as for the fulfillment of regulatory obligations with respect to biopharmaceutical assessment and product quality understanding. The percentage of poorly soluble drugs, defined in classes 2 and 4 of the Biopharmaceutics Classification System (BCS), has significantly increased in the modern pharmaceutical development pipeline. This book provides a thorough exposition of general method development strategies for such drugs, including instrumentation and media selection, the use of compendial and non-compendial techniques in product development, and phase-appropriate approaches to dissolution development. Emerging topics in the field of dissolution are also discussed, including biorelevant and biphasic dissolution, the use on enzymes in dissolution testing, dissolution of suspensions, and drug release of non-oral products. Of particular interest to the industrial pharmaceutical professional, a brief overview of the formulation and solubilization techniques employed in the development of BCS class 2 and 4 drugs to overcome solubility challenges is provided and is complemented by a collection of chapters that survey the approaches and considerations in developing dissolution methodologies for enabling drug delivery technologies, including nanosuspensions, lipid-based formulations, and stabilized amorphous drug formulations.