The Complexity of Excipient Composition

Since the United States Pharmacopeia (USP) and National Formulary (NF) General Notices combined, it could be interpreted that API requirements apply to excipients. In USP–NF General Notices, an API equals the labeled entity plus impurities. Applying this logic to excipients, anything NOT the labeled entity would be an “impurity.” Most excipients are more complex and less well defined than APIs. The excipient name may not reflect its complete composition. The named entity may be a minor component. The other components may be essential for functionality. This article seeks to promote dialogue among stakeholders to facilitate consensus regarding this topic. Due to excipient diversity, including highly complex mixtures from animal, botanical, mineral, and/or synthetic sources, differing approaches to characterizing excipient properties may be required. More complex excipients, including excipients produced by biotechnological methods, may require extensive physico-chemical characterization to fully understand their composition.

More

Recommended for you

• Amorpous stabilization of poorly soluble drugs - Upsalite
• Accelerating pharmaceutical development through predictive stability approaches
• FDA Inactive Ingredient List