Join us for a reception!
The Public House National Harbor
199 Fleet Street
Tuesday, May 7, 6:30 – 9pm
If you’re attending Excipient World, join USP for a reception on the evening of Tuesday, May 7, to meet with other industry professionals and learn about Excipient risk mitigation in an era of increased FDA enforcement. To RSVP for this limited capacity event, email excipients@usp.org and provide name and company of you and your guest(s).
While you’re at Excipient World, be sure to visit USP at Booth #100.
Presentation - Tuesday, May 7, 9:30am:
- The Value of Setting Meaningful Compendial Specifications for Excipients – a USP Perspective; Catherine Sheehan, Senior Director, Science, Excipients.
Posters:
- Microcrystalline Wax: Identification of a Falsified Bulk Material by GC-EI-MS and GC-CI-MS
- Authors: Naíssa Bernardo, Amanda Guiraldelli, Karen Gilbert, Hong Wang (presenter at Excipient World), Jeff Moore
- Abstract: Microcrystalline wax (MCW) is a complex mixture of predominately branched-chain hydrocarbons, and is obtained by solvent fractionation of the still bottom fraction of petroleum by suitable dewaxing or deoiling. It is used as coating and stiffening agent in cosmetic and pharmaceutical formulations, and after further refining as a masticatory substance in chewing gum base, protective coating, and defoaming agent in foods defined in the Food Chemicals Codex as “Petroleum Wax”.
In an effort to modernize the USP–NF monograph for MCW as an excipient, USP has been investigating the use of IR as an identification test for this excipient used in conjunction with a USP RS. To evaluate USP RS bulk candidate materials USP developed two GC-MS methods, using electron and chemical ionization. These methods were used in addition to the current MCW USP–NF monograph tests to characterize a candidate bulk material for USP RS development. The bulk material passed the current monograph tests, while the GC-MS methods identified the bulk material as being consistent with paraffin wax instead of MCW because of higher than expected amount of straight-chain alkanes compared to branched alkanes in this material. Results of this study have improved our understanding of the chemical composition of MCW, provided new GC-MS tools for characterizing bulk materials, and pointed to the need to strengthen the USP–NF monograph to ensure it can distinguish MCW from other wax materials in the marketplace.
- USP Up-To-Date Quality Standards for Excipients: Petrolatum Monographs – Focus on polycyclic aromatic hydrocarbons
- Authors: Tong (Jenny) Liu (presenter at Excipient World), Catherine Sheehan
- Purpose: To present the USP up-to-date and harmonization work on the Petrolatum and White Petrolatum monographs, focusing on the method development, comparison study and specification limit of the polycyclic aromatic hydrocarbons (PAHs). In addition, outreach to the excipients manufacturers and end users to seek feedback on the monograph proposal and promote the compendial standards of Petrolatums.