Compendial reference of USP or NF excipients
- Jeremy Jakob
- Mar 9, 2023
- 1 min read
Updated: Apr 3, 2023
Compendial reference of USP or NF excipients
This information is providing background on the approach which was introduced for referencing excipients, which are in compliance with an USP or NF monograph.
It is recommended to provide in IND/IMPDs and MAA/NDA/BLA dossiers for excipients, which are listed in USP and/or NF the mreferencinguspornfexcipientsinanapplicationore general compendial reference “USP/NF”, if these excipients are tested in compliance with the respective USP and/or NF monograph
Previous standard was to differentiate between excipients listed either in USP or NF to guide the reviewers, in which parts of the USP/NF publication a specific excipient could be found. But recent experience with agencies led to streamline the approach.
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