Modern pharmaceutical analysis: An overview

Abstract

Pharmaceutical analysis simply means analysis of a pharmaceutical(s). Webster's dictionary defines a pharmaceutical as a medicinal drug. It is generally known that a pharmaceutical is a chemical entity of therapeutic interest. A more appropriate term for a pharmaceutical is active pharmaceutical ingredient (API) or active ingredient. In colloquial terms, it is simply referred to as “active”; the use of this term is not encouraged. Even though the term active ingredient is more frequently used, the preferred term is active pharmaceutical ingredient. To distinguish it from the formulated product or drug product, API is also called drug substance. The drug product is prepared by formulating a drug substance with inert ingredients (excipients) to prepare a drug product that is suitable for administration to patients. So it is the drug product that is more likely to be administered to a patient as a medicinal drug than a drug substance by itself. However, it should be recognized that there are situations where a drug substance can be administered after simple dissolution in a solvent such as water. Even in these situations, a suitable pharmaceutical treatment has to be conducted to assure availability and other safety considerations. The various terms mentioned here for API or formulated drug product are used interchangeably in this book; however, it is well known that drug substance and drug product are the preferred terms in regulatory circles. in a solvent such as water. Even in these situations, a suitable pharmaceutical treatment has to be conducted to assure availability and other safety considerations. The various terms mentioned here for API or formulated drug product are used interchangeably in this book; however, it is well known that drug substance and drug product are the preferred terms in regulatory circles.