Mannitol

Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 26-Sept-2014

Official Date: 01–Aug–2015

Expert Committee: Monographs—Excipients

Coordinating Pharmacopoeia: European Pharmacopoeia

A correction to the harmonized standard for Mannitol has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Corr. 1 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 previously posted Stage 6 monograph on February 28, 2014, which is scheduled to become official on December 1, 2014 with the Second Supplement to USP 37–NF 32 include.

  • Definition
    • Changed from “calculated on the anhydrous basis” to “calculated on the dried basis”
  • Assay
    • Acceptance Criteria, changed from “… on the anhydrous basis” to “… on the dried basis”
  • Related Substances
    • Added a note under Table 1 to specify impurities: Impurity A - Sorbitol; Impurity B - Maltitol; Impurity C – Isomalt
  • Reducing Sugars
    • Deleted “Mix equal volumes of the two solutions immediately before use.” from the preparation of Sodium potassium tartrate solution
    • Updated Cupri-tartaric solution to”Mix equal volumes of Copper sulfate solution and Sodium potassium tartrate solution immediately before use.”
  • Nickel
    • Under Analysis, updated the procedure as “…Between each measurement rinse with water, and ascertain that the reading returns to zero with the Blank”.
  • USP Reference Standards
    • Added “USP Endotoxin RS”

The Mannitol monograph will be incorporated into and become official with First supplement to USP 38–NF 33.

Should you have any questions, 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 Group or contact Emily Meyer (301-230-7438 or eam@usp.org).