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Testing and release for pharma and life sciences

Labortest
Healthcare & Pharma

Elemental impurities testing

Synergy Health Utrecht offers cGMP-accredited elemental impurities analysis for pharmaceutical manufacturers, drug substance producers, importers, and wholesalers. Our testing is performed according to the USP <232>/<233>, EP 2.4.20 / 5.20, or your own validated method fully aligned with the latest ICH Q3D guidelines.

With advanced instrumentation and over 15 years of experience, we help you detect, quantify, and control trace elements in your raw materials, excipients, and finished drug products from low parts per trillion (ppt) to high parts per million (ppm).

Why choose Synergy Health Utrecht?

  • cGMP-accredited and ISO 13485-certified laboratory

  • Testing aligned with USP, EP, and ICH Q3D

  • Fast turnaround and expert support

  • In-house QA team ensures compliance and reliability

  • Flexible solutions tailored to your needs

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Our Techniques for Elemental Impurity Testing

We use several validated methods to test both organic and inorganic materials, in aqueous and non-aqueous matrices. Sample preparation is performed using microwave digestion in PTFE vessels. Our elemental impurity testing is commonly used in: - Pharmaceutical manufacturing: ensuring raw materials and drug products meet global safety standards - Drug substance manufacturing: controlling contamination risks and staying compliant - Import & wholesale of pharmaceutical products: verifying quality before release into regulated markets

  • Inductively Coupled Plasma – Mass Spectrometry (ICP-MS)

    - Highly sensitive multi-element analysis (24+ elements) - Conforms to USP <232>/<233> and EP 2.4.20 - Detects trace metals and non-metals from ppt to ppm - Equipped with collision cell technology for accurate results in complex matrices - High Matrix Introduction (HMI) allows direct testing of samples with high dissolved solids

  • Atomic Absorption Spectroscopy (AAS)

    - Quantitative analysis of metals as minor or trace elements - Supports flame absorption, graphite furnace, and flame emission techniques - Hydride Generation AAS (HGAAS) used for arsenic, antimony, mercury, and selenium

  • Atomic Emission Spectrometry (AES)

    - Suitable for simultaneous multi-element detection - Often used in combination with AAS for flexible application

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Pharmazeutische Stabilitätsprüfung

Wir bieten zuverlässige Stabilitätsprüfungen und Probenlagerung für Wirkstoffe (APIs) und fertige Arzneimittel unter vollständig kontrollierten Bedingungen. Von ICH-konformen Klimaschränken bis hin zu individuell angepassten Studienkonzepten gewährleisten unsere Dienstleistungen die langfristige Integrität Ihrer Produkte. Durch umfassende Dokumentation, Trendanalysen und eine sichere Probenverwaltung unterstützen wir Sie dabei, regulatorische Anforderungen zu erfüllen und die Produktqualität über die gesamte Haltbarkeitsdauer hinweg zu sichern.
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