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« FORMULATION AND DEVELOPMENT


of commercial excipient batches, showing how excipient physical/chemical properties may vary. Not all performance-related CMAs of an excipient may be identified or evaluated by specific tests and Acceptance Criteria" listed in compendial monographs.14


As


stated in General Notices 4.10. Monographs, because monographs may not provide standards for all relevant characteristics, some official substances may conform to the USP or NF standard but differ with regard to nonstandardized properties that are relevant to their use in specific preparations.16 To provide general information about performance-related tests linked to specific uses of excipients, USP has developed General Chapter Excipient Performance <1059>.17


USP chapter <1059> is designed to provide an overview of typical excipient material attributes for many functional categories along with additional tests that may be useful in evaluating excipient attributes that are not typically included in compendial monographs. Selection of the appropriate tests and specifications that are necessary to ensure consistent and reliable excipient performance requires an understanding of the formulation and manufacturing processes, the dosage form performance requirements and the physical and chemical properties of each ingredient in the dosage form. The chapter provides references to standard USP–NF test procedures that can be used by both manufacturers and users. Provided USP chapter <1059> is not referenced in an official excipient monograph, any tests performed in accordance with this chapter are considered non-mandatory as far as compliance with the excipient monograph in question. The chapter does not impose limits or specifications since the properties of an excipient that are required will vary and depend upon the product, manufacturing process, quantity, and intended function. Methods from <1059> and corresponding acceptance criteria can be referenced in a drug application. In such an instance, methods that reference USP chapter <1059> and corresponding acceptance criteria for the excipient might be considered part of the specification for the manufacturing of the particular product that is the subject of a drug application.


The workshop attendees discussed the importance of determining how to best ensure that each excipient monograph


Ongoing Challenges to the Excipient Up-to-Date Initiative


reflects the quality of excipients currently used in drugs on the US market and the extent to which monographs can help promote excipient integrity (authenticity and fitness for purpose). There is also a need to understand excipient composition and evaluate how to define and address impurities as opposed to concomitant components. A brief overview was provided on how the


Excipients for Smart Delivery Solutions


www.gattefosse.com


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