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USP Responses to Comments on Stimuli Article “Understanding the Composition and Quality of Polysorbates to Strengthen USP–NF Compendial Standards”

Timothy Frigo, Richard Cawthorne, Barthélemy Demeule, Ting Wang, Jiasheng Tu, Huimin Sun, Umesh Kestur, Ashutosh Rao, Yuda Zong, Erin Wang, Devendra Vasant Chavan, Karen Gilbert, Catherine Sheehan, Tong (Jenny) Liu, Hong Wang

Correspondence should be addressed to: Tong (Jenny) Liu, Principal Scientist, US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790; tel: 1.240.221.2072; email: JYL@usp.org.

In this Stimuli article, the United States Pharmacopeia (USP) responds to comments received concerning the Stimuli article "Understanding the Composition and Quality of Polysorbates to Strengthen USP–NF Compendial Standards", which was published in PF 47(1) [Jan.–Feb. 2021]. The Excipients Expert Committee (EXC EC) published the 2021 Stimuli article along with a survey regarding USP’s understanding of polysorbate (PS) compositions, applications, challenges, and opportunities in strengthening the PS compendial standards. In this second Stimuli article, in addition to the responses to summarized comments, the survey results are also summarized and discussed.

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