Glycerin usp what is




















In addition, in terms of FDA enforcement, a manufacturer could deviate from the impurity requirements established in the monograph by labeling the product to indicate that it deviates from the USP test requirements in this regard. According to section 7. For Identification B, there is no need to determine the water content as this is for qualitative use. FAQs: Glycerin. Avatar Corporation manufactures and sells FDA certified ingredients for use in widely varying applications in the personal care industry including haircare, skin care, oral care and animal health.

Avatar manufactures and sells a variety of FDA certified products which service the pharmaceutical industry. Glycerin The multifunctional nature of Glycerin has led to its utilization in over known end uses. Kosher for Passover grades are available by request.

Because diethylene glycol and ethylene glycol are considered unacceptable toxic substances, the testing of USP Glycerin should demonstrate the absence of these substances. It received comments from several industry groups and companies about technical and timing issues related to this Revision Bulletin. As a result, on May 9, , the Excipients Monographs 1 EM1 Expert Committee postponed the official date of the revised Glycerin monograph, as specified in the Revision Bulletin of March 14, , to allow time for the Expert Committee to further revise and clarify the monograph's requirements.

The new method in the monograph adopted via this Revision Bulletin addresses the comments that were received. Compliance may be determined also by the use of alternative methods as permitted under the USP General Notices.



0コメント

  • 1000 / 1000