ABSTRACT
Characterization of drug substances and excipients is a very important step at the preformulation phase of product development. Although testing will involve additional time and cost, failure to carry out the appropriate characterization tests can be even more costly to manufacturers if the product made is not within specifications. Preformulation characterization of raw materials creates a body of information which is very useful in the development of products. The lack of such information leaves the formulator with little leeway for remediation action when a problem arises from the production process or from the quality of the finished product. It is important to eliminate the possible influences of the raw material characteristics before venturing into investigation of processing variables. The knowledge derived from the characterization of raw materials can also serve to enable better specifications to be drawn up for procuring materials with the aim of either reducing cost or improving product quality. In addition, a review of material characterization results can provide an excellent database for the assessment of suppliers who can provide materials of consistent quality.
