Excipients Community

Dear all,

   AAPS Excipient Community has invited Dr. Hong Wang, Senior Manager at U.S. Pharmacopeia (USP) on Apr 25th 12-1pm US EDT to give a talk on the Excipient Nomenclature Guidelines released to public in 2023. Please check out the abstract and Dr. Hong's Bio. We welcome everyone who's interested to join us in the discussion. Look forward to seeing you!

Presentation Title: Excipient Nomenclature Guidelines

Abstract:

This presentation will introduce the USP Excipient Nomenclature Guidelines released to the public in March 2023 and is the first USP nomenclature guidelines for excipients. Topics covered include the guideline' outlines, excipient classifications, the definition of excipient component, and will further focus on two specific areas, nomenclatures for lipids and polymers which are multiple component-based excipients. With applications of more advanced analytical techniques for lipids and polymers, appropriate naming can be assigned in the USP/NF. Additionally, this discussion will delve into how the guidelines help align the names in USP/NF standards, FDA inactive ingredient database, and the FDA global substance registration system; address FDA's Q1 sameness requirements for complex generics to indicate excipient types in meeting the needs of complex generics and innovative therapeutics; and to guide stakeholders to understand excipient composition and profiles.

Best regards,

Jiaying (Ingrid) on behalf of AAPS Excipient Community LT

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Jiaying Liu
Senior Scientist
Merck & Co, Inc - Rahway, NJ
Kenilworth NJ
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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Dear all,

   Apologize for late update. We had a great discussion on Apr 25th. Really appreciate Dr. Wang's effort on sharing insights of this important topic! Please see slides and additional resources provided by Dr. Wang.

Links:

Please feel free to visit USP web LG Polymers and download the LG polymer flyer. LG Polymers are also called PLGA(s).

USP also posted a LinkedIn on Excipient Quality.

Slides: attached

Best regards,

 Jiaying on behalf of AAPS Excipient Community LT

Dear all,

   AAPS Excipient Community has invited Dr. Hong Wang, Senior Manager at U.S. Pharmacopeia (USP) on Apr 25th 12-1pm US EDT to give a talk on the Excipient Nomenclature Guidelines released to public in 2023. Please check out the abstract and Dr. Hong's Bio. We welcome everyone who's interested to join us in the discussion. Look forward to seeing you!

Presentation Title: Excipient Nomenclature Guidelines

Abstract:

This presentation will introduce the USP Excipient Nomenclature Guidelines released to the public in March 2023 and is the first USP nomenclature guidelines for excipients. Topics covered include the guideline' outlines, excipient classifications, the definition of excipient component, and will further focus on two specific areas, nomenclatures for lipids and polymers which are multiple component-based excipients. With applications of more advanced analytical techniques for lipids and polymers, appropriate naming can be assigned in the USP/NF. Additionally, this discussion will delve into how the guidelines help align the names in USP/NF standards, FDA inactive ingredient database, and the FDA global substance registration system; address FDA's Q1 sameness requirements for complex generics to indicate excipient types in meeting the needs of complex generics and innovative therapeutics; and to guide stakeholders to understand excipient composition and profiles.

Best regards,

Jiaying (Ingrid) on behalf of AAPS Excipient Community LT

Microsoft Teams meeting

Join on your computer, mobile app or room device

Click here to join the meeting

Meeting ID: 234 576 468 255
Passcode: 9dxy8S

Download Teams | Join on the web

Join with a video conferencing device

[email protected]

Video Conference ID: 118 944 342 0

Alternate VTC instructions

Or call in (audio only)

+1 856-295-2448,,548070575#   United States, Camden

Phone Conference ID: 548 070 575#

Find a local number | Reset PIN

Data, including recorded meetings, with content, subject to legal hold must be preserved. By joining this session, you consent to the terms and conditions outlined in the "Legal" link below.

Learn More | Help | 19_meeting_MzgyMGQ5YzYtMzk4MS00ZGVkLWJkN2ItMmVhYmNjZTM5ZDdl@thread.v2&messageId=0&language=en-US" target="_blank" rel="noopener">Meeting options | Legal

------------------------------
Jiaying Liu
Senior Scientist
Merck & Co, Inc - Rahway, NJ
Kenilworth NJ
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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