In Glycerin, why is the Limit test for DEG in the Identification section?
The Limit test was placed in the identification section per the request of the FDA. It makes a difference whether the detection and quantification of DEG is considered part of the Identification test or is considered solely a standard for strength, quality or purity, particularly from a regulatory standpoint. Under the Federal Food, Drug, and Cosmetic Act (FDCA), a drug with a name recognized in USP-NF must comply with compendial identity standards, or be deemed adulterated, misbranded, or both. In addition, if DEG detection and quantification is part of the Identification test, the cGMP regulations at 21 C.F.R. ยง 211.84(d)(l) would require that manufacturers of drug products detect and quantify any DEG present. Furthermore, manufacturers of glycerin could not deviate from the DEG limit since this would be an aspect of identity. In contrast, if DEG detection and quantification is solely part of a purity (impurity) test, a manufacturer need not include as part of its identity testing th
