Our comprehensive analytical services for pharma excellence

Pharmaceutical companies worldwide trust Eurofins BioPharma Product Testing for comprehensive analytical services that ensure drug safety, quality, and regulatory compliance.

Our expertise spans impurity testing, method development, and validation, helping you accelerate drug development while meeting stringent global regulatory standards (FDA, EMA, ICH, and WHO). We also provide support in addressing queries from regulatory authorities.

We provide critical insights through reliable analytical test results to optimize your manufacturing processes and bring safe, effective pharmaceutical products to market faster.

Analytical method development, validation & transfer

Ensure your analytical methods meet global regulatory standards with our advanced capabilities:

Techniques & instrumentation

  • HPLC/UPLC with UV, PDA, RI, ELSD, and CAD detectors
  • GC, GC-HS, GC-MS, LC-MS, LC-MS/MS (QQQ, QToF)
  • Dissolution studies with multipoint profiling
  • pXRD and particle size analysis
  • Infrared (IR) and Ultraviolet (UV) spectroscopy
  • Ion Chromatography for cation/anion quantification
  • 400 MHz NMR

Regulatory alignment

  • Method development, validation, and transfer studies conducted in compliance with ICH, USP, and other global regulatory frameworks.

Process impurities & residual solvents testing

Residual solvents and process-related impurities can affect drug safety, stability, and regulatory approval. Our testing services help you:

  • Detect & Analyse Impurities – Identify and quantify process-related impurities in drug substances and formulations.
  • Ensure Process Efficiency – Verify the effective removal of residual solvents during manufacturing.
  • Meet Regulatory Standards – Comply with ICH Q3C and USP <467> impurity testing guidelines.
  • Minimise Risk – Obtain precise, risk-based assessments to ensure patient safety and regulatory success.

Elemental impurities testing: ensuring drug safety

Elemental impurities, including toxic metals and environmental contaminants, can compromise drug safety. Compliance with ICH Q3D will help you to avoid regulatory delays, product recalls, and reputational risks.

Why elemental impurity testing matters

  • Health risks – Trace amounts of toxic metals (e.g., lead, cadmium, arsenic) can cause severe health issues.
  • Regulatory hurdles – Failing to meet FDA, EMA, WHO guidelines can result in costly setbacks.

Our expertise in elemental impurity testing

  • Method development & validation – Tailored solutions for your drug substances and formulations.
  • Batch analysis – Routine screening to ensure compliance with regulatory limits.
  • Advanced detection technology – ICP-MS for ultra-sensitive quantification at parts per billion (ppb) or trillion (ppt) levels.
  • Regulatory compliance testing – Adherence to ICH Q3D, USP <232>, USP <233>, and USP <730>.

Genotoxic impurity analysis

Genotoxic impurities (GTIs) pose significant safety concerns, requiring precise identification and quantification to meet regulatory requirements.

  • Risk-based assessment – Evaluate genotoxic impurity risks in compliance with ICH M7 (R1), FDA, and EMA.
  • Custom method development – Tailored analytical approaches based on allowable daily exposure limits.
  • State-of-the-art technologies – Utilising GC-MS/MS, HS-GC-MS, LCMS,LC-MS/MS, ICP-MS, HPLC, and GC for accurate analysis.

Frequently Asked Questions ( FAQ )

What impurities do you test for, and why does it matter?

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We test for elemental, genotoxic, process-related impurities, and residual solvents to ensure drug safety, efficacy, and regulatory compliance (USP<232>, USP<233>, ICH Q3D, USP <467>). Identifying harmful contaminants prevents risks to patients and product recalls.

How do you ensure regulatory compliance?

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We follow FDA, EMA, WHO, and ICH guidelines (Q3D for elemental impurity analysis, M7 for genotoxic impurity analysis, USP <467> for residual solvents while staying updated on evolving regulations to keep your products compliant.

What technologies do you use for impurity testing?

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We use HPLC/UPLC, GC, and Ion Chromatography for impurity testing, ICP-MS for elemental impurities and GC-MS/MS & LCMS for genotoxic analysis, delivering precise results at ppb/ppt levels.

Do you offer method development and validation?

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Yes, we provide custom method development, validation, method transfer, and verification of pharmacopeial monograph and client in-house methods ensuring compliance, accuracy, and robustness for your drug substances and formulations.

How do your services accelerate time-to-market?

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Our fast, high-throughput testing, regulatory expertise, and risk-based assessments help identify issues early in drug development and facilitating clients to have remediation measures that can lead to smooth approvals and faster market entry.

Partner with Eurofins BioPharma Product Testing Today

Ensure the safety, quality, and compliance of your pharmaceutical products with industry-leading analytical services.
Contact us today to discuss your testing requirements and how we can support your success.

Eurofins BioPharma Product Testing India – Where Precision Meets Compliance.

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