The American Herbal Pharmacopoeia® develops qualitative and therapeutic monographs on botanicals, including many of the Ayurvedic, Chinese, and Western herbs most frequently used in the United States. These monographs represent the most comprehensive and critically reviewed body of information on herbal medicines in the English language, and serve as a primary reference for academicians, health care providers, manufacturers, and regulators.
Current Good Manufacturing Practices (cGMPs) for dietary supplement ingredients require that manufacturers establish specifications regarding the identity, purity, quality, composition, and limits on contaminants for each dietary ingredient, and that scientifically valid methods be used to ensure that those specifications are met. Each monograph provides the most relevant information needed to comply with cGMPs.
Each AHP monograph provides a variety of identification techniques ranging from botanical identification, macroscopic and sensory characterization, and microscopic identification, to HPTLC and HPLC fingerprinting. Singularly, or used in combination, these methods provide the most complete suite of tests, accompanied by high resolution images against which test samples can be compared to ensure regulatory compliance, and most importantly manufacture a product that will deliver the health benefits expected by health professionals and consumers.
In addition to specific tests, each commercial sources and handling section outlines information for the harvest, cultivation, drying, storage, potential adulterations, as well as other information that can be used to inform purchasing agents regarding the most appropriate sourcing of the material. Additionally, each monograph provides guidance in ensuring the purity of the material, such as limits on foreign matter, ash, and extractives.
Accompanying the standards, is a comprehensive historical summary of the use of the botanical, as well as the AHP Therapeutic Compendium, which provides a complete and critical review of the available pharmacological and safety data, including information on pharmacokinetics, pharmacodynamics, actions, medical indications, historical and modern and traditional use, guidance on appropriate structure and function claims, dosages, interactions, side effects, contraindications, toxicology, and more. This information is critical for the development of substantiation files on structure and function claims, which are also required under cGMPs.
Perhaps most importantly, each AHP monograph is developed and peer-reviewed by an international multi-disciplinary collective of medicinal plant experts, that includes botanists, chemists, herbalists, pharmacists, pharmacologists, physicians, and toxicologists. When completed, each AHP Monograph and Therapeutic Compendium represents the most thorough and critical review of each aspect of the botanical that is of practical use to all sectors of the botanical products industry, including those in product development, purchasing, quality control, regulatory, marketing, research, clinical practice, and education.