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

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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
1

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
  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
-------------------------------------------------------------------------------------------------------------------------------------------

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

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
-------------------------------------------------------------------------------------------------------------------------------------------
and <233>
17

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
-------------------------------------------------------------------------------------------------------------------------------------------
and <233>
18

  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
-------------------------------------------------------------------------------------------------------------------------------------------

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)
-------------------------------------------------------------------------------------------------------------------------------------------

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
-------------------------------------------------------------------------------------------------------------------------------------------

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
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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
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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

26

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
  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
-------------------------------------------------------------------------------------------------------------------------------------------

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
-------------------------------------------------------------------------------------------------------------------------------------------

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
------------------------------------------------------------------------------------------------------------------------------------------

  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
"
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
-------------------------------------------------------------------------------------------------------------------------------

  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.
-------------------------------------------------------------------------------------------------------------------------------

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

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=FFBE22E284F2ED314FC85F
320B0BB587&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: coo@usp.org
Questions About USP
Chapters 232/233
Dr. Zaidi Kahkashan
USP Scientific Liaison for
Elemental Impurities in
Pharmaceutical Materials
Email: kxz@usp.org
Robert Thomas: robert.james.thomas@verizon.net
-------------------------------------------------------------------------------------------------------------------------------------------

Thank You
-------------------------------------------------------------------------------------------------------------------------------------------

50
Trace Elemental Product Information
• Links to Trace Elemental Products:
Trace Elemental Analysis
ICP-MS
ICP-OES
IC-ICP-MS
LC-ICP-MS

51
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

52
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