ABSTRACT
Raw materials used in pharmaceutical manufacturing include active pharmaceutical ingredients and excipients. An active pharmaceutical ingredient (API) is the substance in the drug formulation that is therapeutically active. Excipients are raw materials included in a drug formulation to improve its physical qualities, such as a drug delivery system. Pharmaceutical excipients are classied by the function they perform in a drug formulation, and these include llers, avors, colors, lubricants, preservatives, coatings, disintegrants, and binders. Raw materials are rarely sterile, and some may need to undergo special treatment to render them microbiologically acceptable for use.
These ingredients can be of natural (plant, animal, or mineral) or chemical (synthetic or semisynthetic) origin, which in itself will determine the likelihood of the substance having a high bioload or harboring objectionable organisms. Water, being one of the most common raw materials used in pharmaceutical manufacturing, is specially treated, puried, and carefully monitored, as discussed in Chapter 4.
