Day 1 - US Pharmacopeial Convention

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Methodology – Draft <strong>US</strong>P Chapter � One or two methods - 4400 monographs � Like Residual Solvents, provides procedures d as a starting t ti point i t � For this chapter, verification = validation � Chapter provides minimum validation acceptance criteria – Embodiment of for validation and demonstration of equivalence q to <strong>US</strong>P procedures p � Dietary supplements chapter refers to this chapter for all but methyl mercury and speciation issues Advisory Panel Discussed Potential Detection Techniques � Atomic absorption (flame, graphite furnace, cold vapor) � ICP-OES � ICP-MS � XRF � LIBS � Ion Chromatography � Flame Emission Spectroscopy 11/23/2010 12
Results of Team’s Experiments � Dilute-and-shoot (direct dilution) and � Closed-vessel digestion provided the best results and options for sample preparation procedures � ICP-OES and ICP- MS are compendial options for analytical determinations Elemental Impurities-Procedures � When a user does not have a procedure that meets the criteria for performance described, th then one of f th the referee f procedures d shall h ll be b employed. The procedures include: � Procedure 1, which can be used for elemental impurities generally amendable to detection by ICP-OES � Procedure 2, which can be used for elemental impurities generally amendable to detection by ICP-MS. 11/23/2010 13
Page 1 and 2: Impurities, Adulteration, and the C
Page 3 and 4: A Fifteen Year Saga Begins � 1995
Page 5 and 6: Recent Activities � USP published
Page 7 and 8: Design and Scope of Chapters � Li
Page 9 and 10: Impurities and Limits - Current Pan
Page 11: Some Possible Scenarios Added to th
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
Page 57 and 58: Dose Levels - NOEL no no-observed o
Page 59 and 60: Reference Dose (RfD) �An estimate
Page 61 and 62: Dose-Response Curves (non-carcinoge
Page 63 and 64:
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
Page 179 and 180:
RRealgar l Cinnabar HPLC-ICP-MS Chr
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Correlation between in vitro and in
Page 183 and 184:
Combating Counterfeiting and Substa
Page 185 and 186:
Good Legislation and Regulation Unr
Page 187 and 188:
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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