303-2016-5-24 USP John Hu_Phexfest Chengdu_v2.pdfVIP

5/28/2013 kwc@ USP 1 5/28/2013 USP USP USP 2 5/28/2013 Introduction to USP USP 3 5/28/2013 1820 USP200 40 USP130 4 4 5/28/2013 USP USP USP USP USP USP 5 5/28/2013 – ? ? ? ? ? ? 6 6 5/28/2013 USP ? 3000 ? FDAUSP–NF FCC USPUSP 座机电话号码 7 7 5/28/2013 8 5/28/2013 2010–2015 9 5/28/2013 2010-2015 USP Council of Experts 22 Expert Committees and ? 57 Expert Panels 343 Expert Committee members 386386 ExpertExpert PanelPanel membersmembers 99 FDA Liaisons 25% 33 10 5/28/2013 11 5/28/2013 USP – – – – – – 12 5/28/2013 USP ? ? ? ? 13 5/28/2013 FCC FCC USP HPLC ? NFNFFCCNFFCC HPLC : ? USPHPLC HPLCHPLC 14 5/28/2013 USP Method USP Calcium Benzoate RS Commercial Calcium USP苯 Benzoate 苯 Titration 99.3% 99.6% CofA HPLC 99.3% 43.8% Propionic acid Peak observed % w/w Assay LOD 15.2% 10.7% 5.1% in CofA FT-IR Typical spectrum Peaks in ~2900 cm-1 asymmetric C-H stretch 1H NMR 100% benzoate 36% benzoate : 64% propionate mol % basis Raman Dispersive Typical spectrum Peaks specific to propionate and FT AA Spectroscopy 11.0% of Ca 16.0% Ca MW # Water %Water Theor %Ca 336.35 3 16.1 11.9 336 35 3 16 1 11 9 300.33 1 6.0 13.3 282.31 0 0.0 14.2 15 5/28/2013 USP NFNF-PF383[2012May-Jun] 1S-NF31 HPLCHPLC NLT 99.0%NMT 100.5% NLT 99.0%NMT 101.0% 00.5%5%HPLCHPLC 16 5/28/2013 USP NFNF-PF383 : ? HPLC ?? USP ? USP ? USP ? USP 17 5/28/2013 USP USP—USP 2010-2015 USP- USP FDA 18 5/28/2013 FDA 19 5/28/2013 – ” USP USP 20 5/28/2013 USP – – – USPPF90 FDA – – – 21 5/28/2013 /GC GC/HPLC – /BE 22 5/28/2013 USP – UPLC – – – - FDAORA / BPChP 6 23 5/28/2013 USP Global Laboratory Capabilities USP AAnallytiticall Laboratories USP 24 5/28/2013 -USP ChP-USP #1#1 ? — ? 13 ? 13 – 1990USP – 2005 ? 25 5/28/2013 -USP ChP-USP #1#1 ? 22- MC ChPNF ? 26 5/28/2013 22nd Expert Committee—the Medicines Compendium East Asia Expert Committee USP—USP22 27 27 5/28/2013 ChP-USP ChP2010 USP USP USP – Calcium Stearate USP Lab work complete – Calcium Sulfate – Carnauba Wax – Cholesterol U