General Chapter <2040> Disintegration and Dissolution of Dietary Supplements—Official Date Delayed for Soft Gelatin Capsules to May 1, 2009
In accordance with the Rules and Procedures of the 2005–2010 Council of Experts, the Dietary Supplements-Performance Standards Expert Committee has revised the General Chapter <2040> Disintegration and Dissolution of Dietary Supplements, Dissolution Requirements for Soft Gelatin Capsules official date to May 1, 2009.
This Revision Bulletin retains the following text to exempt soft gelatin capsules from the Dissolution requirements. "Soft gelatin capsule preparations of dietary supplements meet the requirements for Disintegration." The text indicates that soft gelatin capsules will meet the requirements for Disintegration rather than the requirements for Dissolution.
The aforementioned sentence to exempt Dissolution requirements for soft gelatin capsules was included by Interim Revision Announcement (IRA) revision official on January 1, 1995 following the conclusions of the USP Open Conference on Nutritional Supplements held in Cambridge Massachusetts in May 1994. USP intended to indicate that soft gelatin capsules will meet the requirements for Disintegration rather than the requirements for Dissolution. Concomitantly with the IRA revision, USP also stated that "At a later date a revision may be proposed in PF to delete the sentence specifying that soft gelatin capsule preparations meet the requirements for Disintegration, and thereby implement the Dissolution requirements for all capsule preparations."
The proposal to delete the sentence was published in Pharmacopeial Forum volume 32(6) [Nov–Dec 2006]. No negative comments were received and the sentence was deleted from USP 31–NF 26. USP has since heard from industry that many dietary supplements formulated in soft gelatin capsules would not comply with the proposed change by the official date of May 1, 2008. Therefore, the Dietary Supplements–Performance Standards Expert Committee has voted to delay the official date of the Dissolution requirements to May 1, 2009.
All other revisions in this chapter continue to have the May 1, 2008 official date. These include:
- The addition of an Introduction
- Changes to the description of the Disintegration test
- Changes to Disintegration Apparatus B dimensions
- Title change to the Rupture test
- A change in the disintegration time for botanicals
- A change in the disintegration time for sugar coated tablets
- A change in disintegration time for hard gelatin capsules
Should you have any questions, please contact Natalia Davydova, Ph.D. (301-816-8328 or firstname.lastname@example.org).