Ensuring product safety

The testing of trace metals in drug products, drug substances, biologics, dietary supplements, and medical devices is critical in determining the toxicity of a material and predicting its interactions with other compounds. Exova is a recognized world-leader in trace metal analysis. Testing for elemental impurities by ICPOES and ICPMS, in compliance with USP <233>, EP (2.4.20), and ICH Q3D gives you reliable, independent data for both raw materials and finished products.

Our experts can provide you with the information you need on the presence of a full spectrum of trace and heavy metals. We also have the capability to separate and quantitate inorganic mercury, arsenic, and selenium from their various organic species.

Trace metals analysis by ICPMS is also the method of choice to determine residual catalysts, such as palladium and platinum, in in-process intermediates and final products. As an addition to trace metal analysis, we also offer full compendial Active Pharmaceutical Ingredients (API) and excipient testing to the EP, BP, JP, and USP compendia.

Learn more about our services:
  • Determination of unwanted compounds in pharmaceuticals supports method development and product investigations. Ensuring the safety of a product is a critical aspect  of every manufacturing process.

    Unknown Identification
  • Elemental impurities in pharmaceuticals may originate from several sources in the manufacturing process; they may arise from interactions with processing equipment, container closure systems or may be present in components of the drug product.

    Elemental impurities
  • The testing of trace metals in drug products, drug substances, biologics, dietary supplements, and medical devices is critical to determine the toxicity of a material and to predict its interactions with other compounds.

    Speciation analysis
  • Troubleshooting and updating: analytical requirements are ever-changing due to stricter regulations and new manufacturing practices. Exova will work with you in troubleshooting, enhancing and updating your analytical methods to embrace these new requirements.

    Analytical methods

Proven ICPMS experience

Our Exova Santa Fe Springs (Southern California) laboratory was the first commercial laboratory to offer ICPMS. We were also one of the first in the world to offer cGMP compliant ICPOES and ICPMS testing services and have established an enviable reputation in this field. Sharing this extensive experience in trace metals analysis by ICPMS with our other pharmaceutical laboratories assures that your needs are in capable hands.

Our trace metals analysis by ICPMS include:

  • Low detection limits allows testing to trace levels (ppb and ppt)
  • Full metals screen for 68 elements in a single analysis
  • As, Pb, Cd, and Hg by USP <232> and <233>
  • Cr, Cu, Mo, Ni, Pd, Pt, V, Os, Rh, Ru, Ir by USP <232>, <233>, and EP (2.4.20), (5.20)
  • Speciation of selenium, arsenic, mercury and iron
  • Determination of rare elements
  • Metal catalysts and elemental impurities by USP <233> and EP (2.4.20)
  • Arsenic and arsenic speciation in foods and dietary supplements
  • Lead and Cadmium in PVC
  • California Proposition 65 compliance testing
  • ROHS and REACH compliance testing
  • Chromium by ICPMS
  • Hexavalent Chromium - Cr(VI) analysis
  • Lanthanides determination
  • State-of-the-art ICPMS instrumentation
  • Eight ICPMS instruments to meet your needs
  • Numerous established sample digestion techniques, including closed vessel microwave digestion
Meet our experts:
  • Samina Hussain - Senior Chemist/Metals Group Leader

    Specialism - Metals testing by ICPMS. Expert in preparation and analysis.

    Qualifications - BS Chemistry, California Polytechnic University, Pomona: Pomona, CA

    Experience - Over 20 years.

    As the Metals Group Leader at Exova, Ms. Hussain has over 15 years of extensive experience in testing hundreds of different matrices for almost every element on the periodic table. Her expertise in preparing samples for analysis is the cornerstone of her knowledge and includes simple acid digestions, high-pressure ashing, microwave, as well as many other techniques.

    Over the last several years she has been working within the pharmaceuticals industry on USP <232> and <233> and has performed many method validations for dozens of clients. With experience in many industries including pharmaceuticals, medical devices, neutraceuticals, environmental, industrial hygiene, and others, she is considered an expert in testing for trace metals.

    Highlights

    Expert on preparation of 100’s of different matrices for ICPMS and ICP analysis. Expert and advisor to USP and FDA on Heavy Metals by USP <233>. Research expertise includes metals speciation, sample preparation techniques, and heavy metals by wet chemistry.

  • Contact Us

    Whatever your query, we'll pass it on to our experts and respond within a very short space of time.
    More details
Pharmaceutical testing facilities

2395 Speakman Dr.,
Mississauga, ON L5K 1B3

Contact: Larissa Hillar - Operations Manager
Tel: +1 905 822 4111

Fax: +1 905 823 1446

Email: americas@exova.com

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9240 Santa Fe Springs Road,
Santa Fe Springs, CA 90670

Contact: Eric Lindsay - General Manager
Tel: +1 562 948 2225

Fax: +1 562 948 5850

Email: americas@exova.com

Capabilities
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Plot 598-221, Dubai Investments Park 1, The Green Community, P.O. Box: 34924,
Dubai

Contact: Jason Dodds - Managing Director
Tel: +971 4 885 1001

Fax: +971 4 885 4004

Email: middle.east@exova.com

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