Day 1 - US Pharmacopeial Convention

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Comparisons Between Instrumental Methods and (Lewen, N. et al J. Pharm. & Biomed. Anal. 35 (2004) 739-752) Average % Recoveries 120 100 80 60 40 20 0 Pb As Se Sn Sb Cd Pd Pt Ag Bi Mo Ru In Hg Elements The Saga Continues USP Results ICP-MS Results � Post 2005, General Chapters Expert Committee appointed a Heavy Metals subcommittee � Subsequently formed Advisory Panel – In depth expertise in methodology and toxicology – Includes FDA liaisons in both areas � Independent Stakeholder Project Team initiated 11/23/2010 4
Recent Activities � USP published a Stimuli Article in Pharmacopeial Forum (PF) 34(5) for public comment � Discussed at Prescription-Nonprescription Stakeholder Forum meetings held at USP headquarters � Institute of Medicine (IOM) meeting in August, g 2008 to provide p a non-biased view of the methodology and toxicology aspects � Workshop with international participation to gather further input from stakeholders at USP headquarters in April, 2009 Recent Activities � Comments and observations from all activities collected and provided to Advisory Panel for their deliberations � Based on Advisory Panel recommendations, USP published draft documents for comment in PF 36(1) and put on USP web site: – Elements and limits chapter – Methodology chapter – Dietary Supplement chapter – Sti Stimuli li article ti l with ith rationales ti l for f limits li it – Stimuli article with responses to comments on PF 34(5) stimuli article � Follow-up: On USP website - draft chapters with current Expert Panel recommendations (to be updated - not necessarily what will end up in PF) 11/23/2010 5
Page 1 and 2: Impurities, Adulteration, and the C
Page 3: A Fifteen Year Saga Begins � 1995
Page 7 and 8: Design and Scope of Chapters � Li
Page 9 and 10: Impurities and Limits - Current Pan
Page 11 and 12: Some Possible Scenarios Added to th
Page 13 and 14: Results of Team’s Experiments �
Page 15 and 16: Elemental Impurities-Procedures Qu
Page 17 and 18: Stimuli Article: Elemental Impuriti
Page 19 and 20: Acknowledgements Heavy Metals Advis
Page 21 and 22: TOXIC METALS / METALLOIDS REPORTED
Page 23 and 24: Chemical Exposures NHANES III BLOOD
Page 26 and 27: LEAD EXPOSURE IN THE GENERAL U.S. P
Page 28: AMINO ACID COMPOSITIONS KIDNEY PbBP
Page 33 and 34: POTENIAL SIGNIFICANCE OF LEAD LEAD-
Page 35 and 36: Pharmaceutical Applications of Atom
Page 37 and 38: Advantages and Disadvantages of Fla
Page 39 and 40: ICP-MS • Advantages � Very rapi
Page 41 and 42: Laser Induced Breakdown Spectroscop
Page 43 and 44: Proposed Chapter • Companion cha
Page 45 and 46: What’s Next? • USP to publish r
Page 47 and 48: Introduction Contents Toxicity of D
Page 49 and 50: Types of Inorganic Impurities 4
Page 51 and 52: Controls on Heavy Metals (HM): USP
Page 53 and 54: Controls on Heavy Metals (HM) & Lea
Page 55 and 56:
EEvaluation l ti of f Acceptable A
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Dose Levels - NOEL no no-observed o
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Reference Dose (RfD) �An estimate
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Dose-Response Curves (non-carcinoge
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Massachusetts Bay Law Law, Septembe
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Lead as impurities in food or drug
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Lead in pharmaceutical products and
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The Relationship Between Blood Lead
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Acute • GI effects - colic, sever
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Elemental Mercury Found in mercury
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How can Elemental Mercury Enter the
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Inorganic Mercury Poisoning • Gas
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A 27 y.o. male resident of Ramnigar
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Itai Itai-Itai Itai or “ouch “o
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• NOAEL = 5 µg/kg/day • UF = 1
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Proposed Limits (Oral) Elements USP
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Proposed Limits (O (Oral) ) Element
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Points to consider: What concentrat
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Current and Future Directions and I
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Compendial Challenges for Biologica
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Definition - key elements • What
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Identification and the “Absence o
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Strategy for B&B Product Classes Mo
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11/29/2010 11
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Clinical uses of heparin • Treatm
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What was the contamination problem?
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Potential characterization methods
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Orthogonal methods • Orthogonal m
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OSCS contaminated heparin • How d
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Extracted OSCS from 0099‐D01 1 H
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Acknowledgements • Carolyn Swann
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History of adulteration with Diethy
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FDA Request • April 2007: FDA req
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Comments from CDER Office of Compli
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REVISION BULLETTIN IPR Monograph mo
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11/29/2010 10
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Tragic Consequences Not If… But W
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• Collaborative Rx-360 Key Princi
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Rx-360.org Shares Technology That C
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To secure the supply chain 11. Firs
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Common sense dictates the use of ta
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There are many new ideas that can b
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To protect the patients you serve,
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Thank you For More Information 31 J
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Introduction Figure 1. Black Cohosh
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An Opportunity • To our knowledge
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Selection of Marker Compounds Sourc
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Region of Cimifugin (not detected)
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Results Marker Compound Actaea Othe
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Discussion (Cont’d) Important con
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Actions by the Regulator in Respons
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Actions by the Regulator in Respons
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Conclusion • By working together
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QUALITY CONTROL ON SAFETY AND EFFIC
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Study on analytical standards of Af
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Analysis of organic residues of mac
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Extractum Flos Lonicerae Siccus 1 2
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Substantial basis research achieve
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The standard characteristics chroma
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Frame of the quality standards stud
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�Extracting way The factors influ
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RRealgar l Cinnabar HPLC-ICP-MS Chr
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Correlation between in vitro and in
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Combating Counterfeiting and Substa
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Good Legislation and Regulation Unr
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The Regulatory Challenge Poor Regis
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Key Findings Nummber of Samples 16
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Addressing the Problem �Regulated
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Advantages of the Minilab � Requi
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Conclusion �Quality is not a luxu
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11/29/2010 14
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Day 1 - US Pharmacopeial Convention

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