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 firstname.lastname@example.org). For any questions about the PDG and its processes, please see Pharmacopeial Harmonization Group or contact Richard Lew at (240-221-2060 or email@example.com).