Catalog of Standard Reference Materials


Book Description







Handbook of Isolation and Characterization of Impurities in Pharmaceuticals


Book Description

The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product.This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements.It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization.- Provides valuable information on isolation and characterization of impurities. - Gives a regulatory perspective on the subject. - Describes various considerations involved in meeting regulatory requirements. - Discusses various sources of impurities and degredation products.




Reference Materials in Analytical Chemistry


Book Description

Under the guidance of the German Federal Institute for Materials Research (BAM), the standards for fabrication and application of reference materials are presented here in comprehensive form. The areas covered are analytical chemistry, materials science, environmental analysis, clinical and forensic toxicological analysis, and gas and food analysis. A standard reference for every analytical laboratory.




Chemical Reference Materials


Book Description

The accuracy of chemical oceanographic measurements depends on calibration against reference materials to ensure comparability over time and among laboratories. Several key parameters lack reference materials for measurements in seawater, particles in the water column, and sediments. Without reference materials it is difficult to produce the reliable data sets or long-term baseline studies that are essential to verify global change and oceanic stability. Chemical Reference Materials : Setting the Standards for Ocean Science identifies the most urgently required chemical reference materials based on key themes for oceanographic research and provides suggestions as to how they can be developed within realistic cost constraints. Chemical analyses of seawater are uniquely difficult given the poorly known speciation and the low concentration of many of the analytes of interest. Analyses of suspended and sedimentary marine particulate materials present their own distinct challenges, primarily due to potential interference by predominant mineral phases of different types. Of all the analytical methods applied to marine waters and particles, at present only a small fraction can be systematically evaluated via comparison to reference materials that represent the appropriate natural concentrations and matrices. Specifically, the committee was charged with the following tasks: - compile from available sources a list of important oceanographic research questions that may benefit from chemical reference standards; - create a comprehensive list of reference materials currently available for oceanographic studies; - identify and prioritize the reference materials needed to study the identified research questions; - determine for each priority analyte whether reference materials and/or analytic methods should be standardized; and - identify the most appropriate approaches for the development and future production of reference materials for ocean sciences.