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Drug Regulators, FDA – CDER, Publish Guidance on Use of Mechanical Calibration of Dissolution Apparatus CGMP

Filed in manufacturing, February 6, 2010, 4:52 pm , , ,

This guidance is intended to aid drug manufacturers (including ancillary testing laboratories) in calibrating U. S. Pharmacopeia (USP) Dissolution Apparatus 1 and 2 to help assure that critical parameters associated with the dissolution apparatus meet certain mechanical calibration (MC) tolerances.