CEMAS Offers Full Elemental Impurity Testing Aligned with the 2025 Pharmacopoeial Harmonisation
As the pharmacopoeial harmonisation 2025 comes into force, CEMAS is pleased to announce the enhancement of our elemental impurity testing services – now also fully aligned with EP monograph 2.4.20, BP Appendix VIII T and harmonised with ICH Q3D and USP <232>/<233> standards.
Elemental impurities can present serious risks to patient safety, making rigorous, compliant testing more important than ever. Whether you’re developing pharmaceuticals, veterinary medicines, or nutraceutical products, ensuring compliance with these new guidelines is essential.
CEMAS offers:
- High-sensitivity ICP-MS analysis tailored to your matrix and target elements
- Full method validation including spike recovery, repeatability, and system suitability
- Fast turnaround – provisional results within the week
- Full compliance with 2025 harmonised pharmacopoeia and ICH Q3D limits
- GMP-compliant operations and decades of analytical experience
Who Is This For?
- Pharmaceutical manufacturers needing support with pharmacopoeial / ICH compliance
- Veterinary medicine developers navigating impurity limits
- Nutraceutical brands seeking rigorous, science-led testing approaches
- Any company preparing product dossiers for the EU, UK, or international markets
Why Choose CEMAS?
CEMAS has long been a trusted partner for analytical excellence. Our team combines deep technical knowledge with regulatory awareness to deliver results that stand up to scrutiny, from product development to audit readiness.
📩 Contact us today to discuss how we can support your compliance strategy, or take advantage of our “Elemental Advantage Offer”, where we offer progressive incentives on multi-product testing to help you transition smoothly into the 2025 pharmacopoeial harmonisation compliance.
Let us help you keep your portfolio compliant, competitive and safe.