This Stimuli article describes a performance-based monograph (PBM) that specifies tests and acceptance criteria for articles in the US Pharmacopeia (USP) and National Formulary (NF). For selected tests of the monograph, a certified reference material (CRM) from USP would be provided to assist analysts in developing sound procedures. Availability of a default procedure in association with the PBM is considered, pros and cons of the approach are presented, and comments are solicited.
|Original language||English (US)|
|Number of pages||7|
|State||Published - May 1 2009|
ASJC Scopus subject areas
- Drug guides