What does USP Chapter 2232 on Elemental Contaminants in Dietary Supplements Mean for You?

------------------------------------------------------------------------------------------------------------------------------------------- SCIENTIFIC SOLUTIONS: An Independent Consultant Serving the Needs of the Trace Element Community

What Does USP Chapter 2232 on Elemental Contaminants in Dietary Supplements Mean for

You?

June 25, 2015

Robert Thomas, Scientific Solutions Gaithersburg, MD

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Outline of Today’s Presentation

  Role and Mission of the United States Pharmacopeial Convention (USP)   USP Compendial Methods   My Involvement with USP Through the ACS Reagent Chemicals Committee   Overview of Current USP Methods for Elemental Impurities in Pharmaceutical Materials and Dietary Supplements   Detailed Look at USP Chapter 2232 for Heavy Metal Contaminants in Dietary Supplements   Use of USP Chapter 233 for Analytical Procedures to Measure Contaminants in Dietary Supplements   Implementation Timelines and Alignment with ICH Guidelines -------------------------------------------------------------------------------------------------------------------------------------------

SCIENTIFIC SOLUTIONS: An Independent Consultant Serving the Needs of the Trace Element Community 2

Role and Mission of USP

  Mission - To improve the health of people around the world through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods   USP sets standards for the quality, purity, strength, and consistency for drug products – critical to the public health and are recognized and used in more than 130 countries around the globe   These standards, which are published in the United States Pharmacopoeia National Formulary (USP-NF), have helped to ensure public health throughout the world for close to 200 years

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USP Compendial Methods

  The United States Pharmacopeia and The National Formulary (USP–NF) is a book of public pharmacopeial standards, containing standards for drug substances, dosage forms, compounded preparations, excipients, medical devices, and dietary supplements

  It is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF)

  The U.S. FDA designates the USP–NF as the official compendia for drugs marketed in the United States, which must conform to the standards in USP–NF to avoid possible charges of adulteration and misbranding


USP Dietary Supplements Compendium

  In 2009, USP introduced the Dietary Supplements Compendium (DSC)—a resource containing regulatory guidance documents, supplemental information, and reference tools for the industry

  It includes nearly 800 monographs—documentary specifications of identity, strength, quality, and purity etc for dietary supplements, and dietary ingredients, from the USP–NF and FCC (Food Chemicals Codex)

  It also includes information from the USP–NF General Chapters, which are relevant to the individual monographs

  The compendium is published every three years….one is being published this year (2015)


USP-NF Revision/Update Process

  USP creates and continuously revises USP–NF standards through a unique public–private collaborative process, which involves scientists in industry, academia, and government as well as other interested parties from around the world


ACS is an “Interested Party” Through its Handbook of Specifications, Standards and Procedures for Reagent Chemicals

  ACS publish a handbook every 5 years of Specifications and Procedures for ACS-grade reagent chemicals

  Contains purity specifications and analytical methods for over 1000 reagent chemicals and reference materials

  I’ve been a committee member for the past 15 years on the ACS Reagent Chemicals Committee

  Our committee, consisting of approx 25 people (users, manufacturers, academics, consultants), meets twice a year to work on new/updated methodology for the book

  We are currently working on the 11th edition which will be published in October, 2015


A Typical ACS-Grade Reagent Chemical Specification


ACS-Grade Reagent Chemicals Specifications and Procedures

  Because the pharmaceutical and dietary supplement industries use many ACS-grade reagent chemicals, we share many methods and specifications with the USP

  Many reagent specifications in the USP-NF refer to the ACS-grade chemicals

  USP scientists make presentations at our committee meetings to update us on the status of its methodology

  Our members attend USP stakeholder meetings, and panel discussions groups

  I have made a number of presentations at the USP, regarding the use of plasma-based methods for determining trace elements in various pharmaceutical and nutraceutical products


ACS-Grade Reagent Chemicals Specifications and Procedures

  One of our main objectives for the 11th edition is to replace the ACS heavy metals test with plasma-based methods

  I lead the trace element impurities Task Force on the ACS Reagent Chemicals Committee

  For the past three years we have been working on a spike recovery study to validate this new method

  I was given the task of writing the method for the 11th edition of Specifications and Procedures


Replacement of ACS Heavy Metals Test with A Plasma-based Method


ACS Heavy Metals Test


So Why a New USP Heavy Metals Test?

  The test methodology for heavy metals currently in the USP–NF, was first introduced more than 100 years ago

  The test described relies on precipitation of the metal sulfide in a sample, and comparing the color intensity to a lead standard

  USP scientific experts felt that the elemental impurity standards should be updated to incorporate modern methods and health information


Current USP Heavy Metals Test Chapter <231>   Chapter 231is based on a sulfide precipitation of the

analyte elements with a thioacetamide solution, and assumes that all analytes behave in a similar manner to a lead standard (10 ppm) with which samples are compared

  It was initially intended to detect a larger group of elements like Pb, Hg, Bi, As, Sb, Sn, Cd, Ag, Cu, Mo, and Se, but there was no clear definition of which individual elements the method was expected to detect

  Many limitations including low recoveries, inconsistent results and interpretation of color varied with experience of the analyst

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Chapters <232>, <2232> and <233>

  Chapter <231> is now in the process of being eliminated and replaced by: •  Chapter <232>: Elemental Impurities in

Pharmaceutical Products — Limits •  Chapter <2232>: Elemental Contaminants in

Dietary Supplements •  Chapter <233>: Elemental Impurities

Pharmaceutical Products — Analytical Procedures


Overview of New Chapters <232>, <2232> and <233>

Chapter <232>: Elemental Impurities Pharmaceutical Products and Materials - Limits

Specifies the list of 15 elemental impurities (Cd, Pb, As, Hg, In, Os, Pd, Pt, Rh, Ru, Cr, Mo, Ni, V, Cu) and their toxicity limits in pharmaceutical products and raw materials, defined as permitted daily exposure (PDE) levels of the four different drug administration categories - oral, parenteral (intravenous injection), inhalation and large volume parenteral


Chapter <2232>: Elemental Contaminants in Dietary Supplements Specifies the list of 4 elements (Pb, As, Cd, Hg) and their toxicity limits, defined as permitted daily exposure (PDE) levels. This chapter refers to Chapter <233> for the analytical procedure to determine the elemental contaminants



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Chapter <233>: Elemental Impurities - Procedures Covers the sample preparation, analytical procedure and QC validation protocols for measuring the elements, using ICP-AES or ICP-MS or any alternative technique that meets the validation requirements



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  The objective of this general chapter is to set limits for the amount of elemental contaminants in finished dietary supplement labeled as conforming to USP-NF standards

  The focus of this chapter is on the four major elements of toxicological concern – As, Cd, Pb and Hg

  This chapter is not intended to set limits for the actual dietary ingredients – those limits are set in the individual monographs

General Chapter <2232> Elemental Contaminants in Dietary Supplements


Chapter <2232> Permitted Daily Exposure (PDE)Levels   The levels of elemental contaminants should be less than the Permitted Daily

Exposure (PDE) levels shown in the table below:

  PDE levels derived from data supplied by the Food Agriculture Organization of the

United Nations (FAOUN) and World Health Organization (WHO), based on a body weight of 50 kg and other safety factors

  Manufacturers are responsible for compliance with other applicable local requirements (e.g. Proposition 65 in California) differing from these PDE values

Elemental Contaminant USP Chapter <2232> PDE Limits (µg/day)

Arsenic (Inorganic) 15

Cadmium 5

Lead 5

Mercury 15 (total)

Methyl Mercury (CH3Hg) 2


Element Oral Daily Dose PDE (µg/day)

Parenteral Daily Dose PDE (µg/

day)

Inhala9on Daily Dose PDE (µg/

day)

LVP Component Limit (µg/g)

Cadmium 5.0 2.5 3.4 0.25 Lead 5.0 5.0 5.0 0.5 Arsenic (Inorganic) 15 15 1.9 1.5 Mercury (Inorganic) 15 1.5 1.2 0.15 Iridium 100 10 1.5 1.0 Osmium 100 10 1.5 1.0 Palladium 100 10 1.0 1.0 PlaAnum 100 10 1.5 1.0 Rhodium 100 10 1.5 1.0 Ruthenium 100 10 1.5 1.0 Chromium * * 2.9 * Molybdenum 180 90 7.6 9.0 Nickel 600 60 6.0 6.0 Vanadium 120 12 1.2 1.2 Copper 1300 130 13 13

USP Chapter <232> Permitted Daily Exposure (PDE)Levels

PDEs based on an arbitrary adult human body weight of 50 kg (110 lb) (* = Not considered a safety concern) ------------------------------------------------------------------------------------------------------------------------------------------- SCIENTIFIC SOLUTIONS: An Independent Consultant Serving the Needs of the Trace Element Community 21

Comparison Between <2232>, and <232> for the 4 Major Elements of Toxicological Concern

Element/Species <2232> PDE (µg/day)

<232> Oral Daily Dose PDE (µg/day)

Arsenic (Inorganic) 15 15

Cadmium 5 5

Lead 5 5

Mercury (Total) 15 -

Methyl Mercury (as Hg)

2 -

Inorganic Mercury - 15


Determination of Inorganic Arsenic and Methyl Mercury by Chapter <2232>

  Arsenic may be measured using a non-speciation procedure, under the assumption that all arsenic contained in the supplement is in the inorganic form

  Where the arsenic limit is exceeded using a non-speciation procedure, compliance with the limit for inorganic arsenic shall be demonstrated on the basis of a procedure described in Chapter 211 (conversion of As to AsH3 the complexed and measured colorimetrically)

  Methyl mercury determination is not necessary when the content for total mercury is less than the limit for methyl mercury. When the total mercury content is higher than the methyl mercury limit, a speciation method is recommended (2232 specifies separation by LC and detection by cold-vapor AA)

  But any method is suitable, as long as it gives equivalent results ------------------------------------------------------------------------------------------------------------------------------------------- SCIENTIFIC SOLUTIONS: An Independent Consultant Serving the Needs of the Trace Element Community 23

Chapter <2232> Options for Compliance with the Necessary Limits of Elemental Contaminants

  In order for a dietary supplement to comply with the limits for elemental contaminants as described in this chapter, the levels in the finished product should be no more than (NMT) the PDE

  The following three options are available for determining compliance with the limits for elemental contamination in dietary supplements: 1.  Dietary Supplement Analysis Option 2.  Individual Component Option 3.  Summation Option


Dietary Supplement Option

  In this option, the finished dietary supplement is analyzed according to the procedure in Chapter <233>.

  The results obtained from the analysis of a typical serving size, based on the maximum daily dosage of the supplement recommended on the label (servings/day) should be no more than the PDE values


Individual Component Option   This option is applicable to a finished dietary supplement with a

daily intake of a maximum of 10 g or less   Carry out the analysis of the individual ingredients of the dietary

supplement according to method described in Chapter <233>   The product meets the requirements when each component used

in production of the finished product meets the limits given in the table below


Elemental Contaminant USP Chapter <2232> Individual Component Limit (µg/g) Based

on a Dosage of 10g/day

Arsenic (Inorganic) 1.5

Cadmium 0.5

Lead 0.5

Mercury 1.5 (total)

Methyl Mercury (CH3Hg) 0.2

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Summation Option:

  This option is used for the finished dietary supplement dosage that is consumed in quantities greater than 10 g/day, or where the acceptance limit for any contaminant in any component of the dietary supplement exceeds the individual component limit

  Carry out the analysis of the individual ingredient and calculate the amount of each elemental contaminant (in µg/daily dosage) present in the dietary supplement

  The amount of each elemental contaminant in the daily dosage should be no more than the PDE values


Analytical Procedures for Total Elemental Contaminants in Dietary Supplements

  Performance-based methodology for the analysis of elemental contaminants described in General Chapter <233>, is applicable for dietary supplements

  With all 3 options described in this method, the use of validation protocols described in Chapter <233 are appropriate

  Although the validation procedures described in Chapter <233> are strongly recommended for the analytical technique of choice, the level of validation is at the discretion of the supplement manufacturer and the regulatory authority


  This chapter describes the two analytical procedures for the evaluation of the levels of elemental impurities •  Procedure 1: ICP-OES •  Procedure 2: ICP-MS

  Gives guidelines on sample preparation, calibration procedures, spike recoveries, precision and instrumental drift limit

  The chapter also describes criteria for alternative procedures as long as they meet the validation requirements laid-out in this chapter

  No speciation methods described in this chapter

General Chapter <233> Elemental Impurities: Procedures


Chapter 233 Elemental Impurities –Procedures Sample Preparation

  Neat: Used for liquid samples   Direct Aqueous Solution: When a sample is soluble in an

aqueous/acid medium   Direct Organic Solution: When a sample is only soluble

in an organic solvent   Indirect Solution: When a sample is not directly soluble

in an aqueous or organic solvent •  Closed vessel digestion procedures (e.g.. microwave) •  Gives an example of a microwave digestion procedure

  In certain cases, a leaching procedure can be used ------------------------------------------------------------------------------------------------------------------------------------------- SCIENTIFIC SOLUTIONS: An Independent Consultant Serving the Needs of the Trace Element Community 30

Chapter 233 Elemental Impurities –Procedures Calibration Procedure: Suitability of Technique

  Target Limit/Concentration (J) is the concentration of the elements of interest, appropriately diluted to the working range of the instrument •  E.g.: Limit for Pb = 5 µg/day. Based on a suggested dosage of 10 g of

supplement/day, that’s equivalent to 0.5 µg/g (ppm) Pb. If 0.2 g of sample is digested/dissolved and made up to 100 mL, that’s a 500-fold dilution, which is 1 µg/L (ppb). So J for Pb is 1 µg/L, based on this dilution factor

  A Calibration is then made up of 2 standards •  Standard 1= 2.0J, Standard 2= 0.5 J •  For Pb that’s 2 µg/L (Std 1) and 0.5 µg/L (Std 2)

  Calibration drift is measured by comparing results for Standard 1 before and after the analysis of all the sample solutions under test •  Drift should be < 20% for each target element


Chapter 233 Elemental Impurities –Procedures Validation Protocols

  For elemental impurities limit procedures, validation tests should include: •  Detectability (impact of matrix on target elements) •  Precision (repeatability) •  Specificity (impact of target elements on each other) •  Accuracy (using reference materials) •  Limit of Quantification (suitability of technique being used) •  Linear Range (suitability of technique to measure “out of

spec” values using same calibration) •  Ruggedness (robustness of method)

•  Refer to USP-NF General Chapter <1225> Validation of Compendial Procedures for guidance

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  Prepare a Standard Solution of target elements at J and a matrix matched blank

  Prepare an unspiked sample   Prepare a sample spiked at J – Spiked Sample

Solution 1   Prepare a sample spiked at 0.8J - Spiked Sample

Solution 2 •  Note: The sample under test must be spiked

before any sample preparation/dilution steps are carried out

"

Chapter 233 Elemental Impurities –Procedures Validation Protocols - Detectability



  Non-instrumental Acceptance Criteria (suitability of sample preparation procedure) •  Spiked Sample Solution 1 must give a signal

intensity equal to or greater than the Standard Solution

•  Spiked Sample Solution 2 must give a signal intensity less than the Spiked Sample Solution 1

•  The signal for each spiked sample is not less than the unspiked sample

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  Instrumental (Assessment of Sample Matrix on Analyte Signal) •  The average value of the three replicate

measurements of Spiked Sample Solution 1 is within ±15% of the average value obtained for the replicate measurements of the Standard Solution.

•  The average value of the replicate measurements of Spiked Sample Solution 2 must provide a signal intensity less than that of the Standard Solution.

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  Test samples: six independent test material solutions spiked at J   Acceptance criterion: RSD < 20%

Chapter 233 Elemental Impurities –Procedures Validation Protocols – Precision/Repeatability


  The procedure must be able to unequivocally assess each Target Element in the presence of components that may be expected to be present, including other Target Elements, matrix components, and other potential interferences.

  N+1 solution approach ( N= # of target elements) •  Solution 1 – All Target elements •  Solution 2 – All Target elements w/o Lead •  Solution 3 – All Target elements w/o Cadmium •  Solution 4 – All Target elements w/o Arsenic •  Solution 5 – All Target elements w/o Mercury

Chapter 233 Elemental Impurities –Procedures Validation Protocols - Specificity


  Standard Solutions: •  Prepare solutions containing target elements at concentrations ranging

from 50-150% of J using suitable calibration/reference materials

  Test Samples: •  Prepare samples under test by spiking at concentrations from 50-150%

of J using suitable calibration/reference materials

  Acceptance Criteria: •  Measure three replicates of the different concentration samples •  Spike recovery of three reps should be 70%-150% at each concentration

Chapter 233 Elemental Impurities –Procedures Quantitative Procedure Validation: Accuracy, LOQ and Linear Range


  The effect of random events on the analytical precision of the method shall be established

  Acceptable experiments for establishing intermediate precision include performing the ‘Repeatability’ analysis

•  On 3 different days OR •  With 3 different instruments OR •  With 3 different analysts

  Executing only one of these three experiments is required to demonstrate ruggedness

  Acceptance criterion   RSD <25% for each element

Chapter 233 Elemental Impurities –Procedures Quantitative Procedure Validation: Ruggedness


Approval Status of USP Chapters on Elemental Impurities/Contaminants   The pharmaceutical/nutraceutical industries were concerned about the

ambitious timing of these new chapters   In addition, international regulatory agencies such as the ICH

(International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), European Medicines Agency (EMA), and the European Pharmacopoeia (EP) and Japanese Pharmacopoeias (JP) disagreed about the list of elements and permitted daily exposure (PDE) limits defined in Chapter <232>

  For this reason, there have been a number of revisions to both Chapter <232> and <233>, which resulted in implementation timelines being modified a number of times

  However, a recent announcement by the USP Chemical Analysis Expert Committee stated that it is the intention to align Chapter <232> Elemental Impurities—Limits with the ICH Q3D Step 4 directives…. but no details yet!


ICH Q3D Step 4 Guidelines: Official on 16 Dec, 2014

USP 232

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Comparison Between <2232>, <232> and ICH Guidelines for the 4 Major Elements of Toxicological Concern

Element/Species Chapter <2232> PDE (µg/day)

Chapter <232> Oral Daily Dose PDE

Limits (µg/day)

ICH Q3D Step 4 Guidelines for Oral

Daily Dose PDE Limits (µg/day)

Arsenic (Inorganic) 15 15 15

Cadmium 5 5 5

Lead 5 5 5

Mercury (Total) 15 - 30

Methyl Mercury (as Hg)

2 - -

Inorganic Mercury - 15 -


  Chapter published in the First Supplement to USP 36–NF 31 on February 1st, 2013

  It became official on December 1st, 2014 with the publication of 2nd Supplement to USP 37–NF 32

  However, full implementation will be dependent on implementation of Chapters <232> and <233> on Elemental Impurities – Limits and Procedures, which is still on target for January 1st, 2018 (assuming alignment with ICH guidelines is on schedule?)

  ICH Guidelines will become official on Dec 16, 2017

So What is the Status of USP General Chapter <2232> at this Moment in Time?


Further Reading on the Topic (USP)   United States Pharmacopeia General Chapter <231> Heavy Metals Test in USP National

Formulary (NF); http://www.usp.org/usp-nf/notices/affected-omission-general-chapter-231-heavy-metals

  United States Pharmacopeia General Chapter <232> Elemental Impurities in Pharmaceutical Materials – Limits: 1st Supplement of USP 37-NF 32; http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/key-issues/2013-12-27_232_pf40-2.pdf

  United States Pharmacopeia General Chapter <233> Elemental Impurities in Pharmaceutical Materials – Procedures: 1st Supplement of USP 37-NF 32; http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/key-issues/2013-12-27_233_pf40-2.pdf

  General Chapter <2232> Elemental Contamination in Dietary Supplement: 1st supplement of USP 37 – NF-32; http://www.usp.org/usp-nf/notices/general-chapter-elemental-contaminants-dietary-supplements

  USP's Proposed Standards for Elemental Impurities: Frequently Asked Questions; http://www.usp.org/support-home/frequently-asked-questions/frequently-asked-questions-usps-proposed-standards-elemental-impurities

  USP 37 General Rules and Requirements: http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/revisions/2013-07-09_general_notices_usp37-nf32_final.pdf

  United States Pharmacopeia Update Communications, Spring, 2015: http://www.usp.org/usp-nf/key-issues/elemental-impurities


Further Reading on the Topic (Misc)   ICH Quality Directives for Elemental Impurities, Q3D Step 4 Guidelines: http://

www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3D/Q3D_Step2b.pdf

  A Guide to California’s Proposition 65 for the Nutritional Supplement Industry: Alliance for Natural Health: http://www.anh-usa.org/wp-content/uploads/2013/04/Prop-65-manual.pdf

  Heavy Metals: Analysis and Limits in Herbal Dietary Supplements, American Herbal Products Association: http://www.naturalhealthresearch.org/wp-content/uploads/2013/02/09_1214_AHPA_Heavy-Metals-White-Paper-Revised.pdf

  US EPA Mercury Preservation Techniques: http://www.epa.gov/esd/factsheets/mpt.pdf   Spectroscopy Online Webinar: Upcoming Changes and Implementation Timelines to USP–

NF General Chapters 231, 232, and 233 on Elemental Impurities: Dr. Kahkashan Zaidi, USP Liaison for Chapters 232/233 https://event.on24.com/eventRegistration/EventLobbyServlet?target=registration.jsp&eventid=778671&sessionid=1&key=FFBE22E284F2ED314FC85F320B0BB587&sourcepage=register

  What's New in Testing Pharmaceuticals for Metals: Metals and Limits in Limbo; N. Lewen, Spectroscopy Magazine, Volume 29, Issue 5, pp. 42-50, May, 2014 http://www.spectroscopyonline.com/spectroscopy/Articles/Whats-New-in-Testing-Pharmaceuticals-for-Metals-Me/ArticleStandard/Article/detail/842937


Further Reading on the Topic (RT)

  Practical Guide to ICP-MS: A Tutorial for Beginners – 3rd edition: Robert Thomas, CRC Press, http://www.crcpress.com/product/isbn/9781466555433

  Beginners Guide to ICP-MS: 15 part tutorial series: Robert Thomas, Spectroscopy Magazine, 2003: http://scientificsolutions1.com/icpmstutorial.html

  PittCon Short Course: How to Select an ICP-Mass Spectrometer: The Most Important Analytical Consideration: Robert Thomas https://ca.pittcon.org/Technical+Program/tpabstra15.nsf/SCoursesByCat/15393F680829A5EB85257CF20071C32E?opendocument

  PittCon Short Course: Implementation of New USP Chapters <232> <233> and <2232> on Elemental Impurities in Pharmaceutical Products and Dietary Supplements: Robert Thomas https://ca.pittcon.org/Technical+Program/tpabstra15.nsf/SCoursesByCat/024E2645EBA1F38A85257CF20072EEAD?opendocument

  Determining Elemental Impurities in Pharmaceutical Materials: How to Choose the Right Technique, Spectroscopy, March 1, 2015; http://www.spectroscopyonline.com/determining-elemental-impurities-pharmaceutical-materials-how-choose-right-technique


Assuming USP Doesn’t Move the Goalposts Again, Chapters <232> <2232> and <233> Should be Fully Implemented by January 1, 2018

Questions About USP Chapter 2232

Dr. Christopher Okunji USP Scientific Liaison for Elemental Contaminants in Dietary Supplements

Email: [email protected]

Questions About USP Chapters 232/233

Dr. Zaidi Kahkashan USP Scientific Liaison for Elemental Impurities in Pharmaceutical Materials

Email: [email protected]

Robert Thomas: [email protected]


Thank You


Thermo Scientific

Resources

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Trace Elemental Product Information

•  Links to Trace Elemental Products: Trace Elemental Analysis ICP-MS ICP-OES IC-ICP-MS LC-ICP-MS

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Food/Beverage and Dietary Supplement Community: Resources •  View application notes, on-demand webinars, product information, and

more resources on our Dietary Supplement and Food Communities pages: www.thermoscientific.com/dietarysupplements

www.thermoscientific.com/foodandbeverage

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What does USP Chapter 2232 on Elemental Contaminants in Dietary Supplements Mean for You?

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Transcript of What does USP Chapter 2232 on Elemental Contaminants in Dietary Supplements Mean for You?