Anhydrous Lactose

Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 29–Feb–2012 (updated 27-Feb-2017*)

Official Date: 01–Dec–2012

Expert Committee: Monographs—Excipients

*Coordinating Pharmacopeia: EP

A harmonized standard for Anhydrous Lactose 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 Anhydrous Lactose 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:

  • Elimination of local attribute Identification C, as this procedure was determined not to be necessary by the Expert Committee.
  • Updated test for Content of Alpha and Beta Anomers, replacing the packed column GC method with an updated capillary column GC method.
  • Updating test for Clarity and Color of solution to provide concise definition for Clear and Colorless with acceptance criteria, consistent with signed off harmonized text.
  • Modified acceptance criteria for Acidity and Alkalinity to allow for a pink or red endpoint, consistent with common laboratory practice.

The Anhydrous Lactose monograph will be incorporated into and become official with the Second Supplement to USP 35–NF 30.

*Should you have any questions about the Benzyl Alcohol monograph, please contact Dr. Tong (Jenny) Liu (240-221-2072 or jyl@usp.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 rll@usp.org).

*The previous PDG sign-off Cover Pages and Stage 6 postings are included as below: