Analytical and Chemical Standards Information

Analytical standards and chemical standards are highly-characterized specimens of drug substances, excipients, impurities, degradation products, dietary supplements, compendial reagents, or performance calibrators. They consist of standard values or standard specimens that are used to compare chemical samples with the results of a test or the characteristics of a finished product. Because the quality of a chemical substance or product can be determined through its compliance with these benchmarks, analytical and chemical standards provide a valuable control or reference for checking laboratory or production results, especially in highly-regulated industries or in medical applications where drug purity and drug potency are critical. 

Most analytical and chemical standards represent minimum specifications established by regulatory bodies, voluntary standards organizations, or government agencies. In some industries such as pharmaceuticals and chemical processing, manufacturers may implement additional analytical and chemical standards. Examples include standards for chemical testing, metallurgical testing, pharmaceutical testing, materials science, and nanotechnology. Organizations that establish and maintain analytical and chemical standards include the National Institute of Science and Technology (NIST) and the American Society for Testing and Materials (ASTM).  

Analytical and chemical standards are classified in various ways, but typically by type and application. Types of analytical and chemical standards include alloy standards, chemical standards, crystal structure standards, food additive standards, metal standards, pH standards, water standards, and X-ray diffraction standards. Polymer standards, ore standards, and mineral standards are also available. Some analytical and chemical standards are used in agricultural applications, or to test adhesives, sealants, cements, ceramics, cleaners, coatings, coolants, or cosmetics. Other products are used to test elastomers, electronics, foods, fibers, fuels, lubricants, and pharmaceuticals.   

Analytical standards and chemical standards differ in terms of form and features. Choices for form include liquid or solution, colloid or dispersion, powder, and bulk solid or granules. In terms of features, some analytical standards and chemical standards are made of inorganic chemicals or salts. Others are made of organic chemicals or polymers. Analytical standards are also made of artificial or synthetic substances, or designated as natural or biodegradable. Anionic agents or additives produce anions while cationic agents or additives produce cations.