Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 26–Apr–2013; updated 26–Jul–2013 (updated 28–Feb–2017*)
Official Date: 01–May–2014
Expert Committee: Monographs—Excipients
*Coordinating Pharmacopeia: USP
A harmonized standard for Corn Starch has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Sign-Off Cover Page. Having reached Stage 6 of the PDG process, the Corn Starch monograph has been formally approved by the USP Monographs—Excipients Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.
Changes from the existing USP–NF monograph include:
- For Identification A, eliminated requirement using NLT 20X magnification as this detail is not part of the harmonized text.
- Eliminated USP National text notification for the total aerobic microbial count, the total combined molds and yeasts count, and the absence of E. coli as these are now harmonized tests.
The Corn Starch monograph will be incorporated into and become official with USP 37–NF32.
*Should you have any questions about the Benzyl Alcohol monograph, please contact Dr. Tong (Jenny) Liu (240-221-2072 or firstname.lastname@example.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Group or contact Richard Lew at (240-221-2060 or email@example.com).
*The previous PDG sign-off Cover Pages and Stage 6 postings are included as below:
- Download the Corn Starch Monograph – Stage 6
- Download the Corn Starch PDG Sign-Off Cover Pages:
- Previous Stage 6 posting in PF 35 (3), 2009
- Previous Stage 6 posting in PF 30 (5), 2004
- Previous Stage 6 posting in PF 30 (4), 2004
- Previous Stage 6 posting in PF 30 (2), 2004
- Previous Stage 6 posting in PF 28 (3), 2002