Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 28–Feb–2014
Targeted Official Date: 01–Dec–2014
Expert Committee: Monographs—Excipients
A harmonized standard for Mannitol has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Sign-Off Cover Page. Having reached Stage 6 of the PDG process, the Mannitol 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 the introduction to the following new tests which supports USP’s modernization initiatives:
- IR Identification
- Nickel
- Appearance of Solution
- Conductivity
- Microbial Enumeration and Tests for Specified Microorganisms
- Bacterial Endotoxins (if intended for the manufacture of parenteral dosage forms)
- Labeling to indicate concentration of bacterial endotoxins, where applicable if the substance is suitable for the manufacture of parenteral dosage forms.
Changes from the existing USP–NF monographs include revisions to the existing tests.
- Revised HPLC Assay and Related Substances Test to include a column change from “4-mm x 25-cm” to “7.8-mm x 30-cm” and to change the acceptance criteria of Assay from “96.0%-101.5% on the dried basis” to “97.0%-102.0% on the anhydrous basis”.
- Reducing Sugars – new procedure
- Melting Range (change from 164-169 to 165-170)
- Loss on Drying (change from NMT 0.3% to NMT 0.5%)
In addition, the monograph has been edited to be consistent with the current USP style guide.
The Mannitol monograph will be incorporated into and become official with the Second Supplement to USP 37–NF 32
Should you have any questions about the Mannitol monograph, please contact Kevin Moore (301-816-8369 or ktm@usp.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization website or contact Emily Meyer (301-230-7438 or eam@usp.org).