<696> Crystallinity Determination by Solution Calorimetry

Type of Posting: 
Notice of Adoption of Harmonized Standard
Posting Date: 
29–Feb–2012
Official Date: 
01–Dec–2012
Expert Committee: 
General Chapters—Physical Analysis

A harmonized standard for <696> Crystallinity  Determination by Solution Calorimetry  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 <696> Crystallinity  Determination by Solution Calorimetry  General Chapter has been formally approved by the USP General Chapters-Physical Analysis Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.

Changes from the existing USP–NF General Chapter include:

  • Introduction is revised to include:
    • A reference to chapter <941> Characterization of Crystalline and Partially Crystalline Solids by X-ray Powder Diffraction.
    • The concept of polymorphism.
  • Added a new section:  Method 1-Microcalorimetry (Determination of Amorphous Content.
  • Revised Method 2 to include only the relevant technique-related information.

The <696> Crystallinity  Determination by Solution Calorimetry  General Chapter will be incorporated into and become official with the Second Supplement to USP 35–NF 30.

Should you have any questions about the <696> Crystallinity Determination by Solution Calorimetry  General Chapter, please contact  Kahkashan Zaidi (301-816-8269 or kxz@usp.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Web page or contact Mario Sindaco (301-816-8246 or mys@usp.org).