ABSTRACT
Active Pharmaceutical Ingredients are also known in regulatory and pharmacopeial parlance as ‘‘Drug Substances’’. Additional terms frequently employed in commerce and the literature are Bulk Pharmaceutical Compound (BPC), Bulk Actives, and ‘‘active ingredient’’. All terms relate to the same ‘‘article’’. New chemical entities (NCE), also termed new molecular entities (NME) refer to drug substances that are ¢rst to enter the drug regulatory arena under the banner of a NewDrug Application (NDA) .The term ‘‘o⁄cial substance’’‘‘is de¢ned in the USP as an active or inactive ingredient (frequently termed an excipient), a nutrient, a dietary supplement ingredient, and=or a pharmaceutical ingredient, or a component of an o⁄cial device’’ (1). O⁄cial substances are the subject of formal monographs in the USP or NF. Drug substance (API) monographs grace the USP exclusively. The other o⁄cial articles noted are in other sections of the compendia. Not surprisingly, the end use of the API is to produce a drug product, which
is the ¢nal form of the drug substance administered to patients. Drug products are the subjects of companion monographs in the USP. The ultimate safety and e⁄cacy of the ¢nally administered drug product are dependent on the assurance of the consistency of the physical and chemical properties of the API. This chapter will focus on the plethora of issues involved with theAPI,which must be considered when developing a generic drug product. In particular, the point of establishing speci¢cations for critical quality attributes of the API that will assure that the generic drug product, employing the API material, will have consistent in vitro=in vivo characteristics, batch after batch. As part of the routine evaluation of the compendial status of an API, in addition to the USP, the EP, JP, BP, IP, and other ‘‘recognized’’ compendia should be checked to verify the presence or absence of published ‘‘o⁄cial monographs’’ for theAPI.
