Choosing the right excipient manufacturer can help ensure the use of quality excipients.

How does one define quality as applied to excipients? If we pose the same question for APIs, the response would be to produce the ingredient under appropriate GMPs, and to the compendial monograph and the API assay. Because the monograph provides the minimum requirements, API quality is improved by reducing the presence of all materials other than the desired chemical. This is logical because, by definition, the API is “intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body” (1). Extraneous substances may be harmful to the patient in that they may lead to side effects, or they are inert, thus reducing API purity and thereby compromising efficacy.

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