USP hard gelcap dissolution test proposal takes effect Dec. 1; soft gel standard to follow.
This article was originally published in The Tan Sheet
Executive Summary
USP GELATIN HARD CAP DISSOLUTION TESTING STANDARD, EFFECTIVE DEC. 1, will permit manufacturers to perform postmarket enzyme-enhanced gelcap dissolution tests, United States Pharmacopoeia Division of Standards Development scientist Vivian Gray announced at the annual meeting of the American Association of Pharmaceutical Scientists, held in Boston Nov. 2-6. The standard, to be published in USP's Pharmacopoeial Forum (236), "will be official Dec. 1; it is a legal standard enforced by USP and followed and enforced by FDA," Gray stated.
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