Precise determination of active ingredient content is crucial for the effectiveness and safety of pharmaceutical products. Our assay tests provide accurate quantitative analyses of the active ingredients in your formulations. We work with previously developed or standard methods (Ph. Eur., ICH) according to the latest guidelines, including ICH Q14 and ICH Q2(R2).
Impurities can affect the safety and efficacy of pharmaceuticals. Our impurity testing services identify and quantify impurities in your products. When necessary, we employ high-resolution mass spectrometry for enhanced detection capabilities.
Nitrosamines are potentially carcinogenic compounds undesirable in pharmaceutical products. We detect and quantify these challenging analytes in your drug products according to EMA guidelines and we can also test for product-specific nitrosamines.
Ensuring the safe handling of active pharmaceutical ingredients (APIs) is critical for both employee protection and environmental stewardship. Our active substance analysis services support your compliance with occupational safety standards and environmental regulations.
Cleaning validation is essential to prevent cross-contamination in pharmaceutical production. Our experts optimize sampling procedures and develop customized sample preparation solutions tailored to your specific needs. Our flexible sample analysis adapts to your project requirements, ensuring precise and reliable validation that comply with current regulatory requirements. Additionally, we offer analytical support for the qualification of sampling by factory employees and dedicated training programs. We focus primarily on high potency drug applications.
Lipid-based formulations are essential for improving the bioavailability and stability of challenging drug substances. Our analytical services for lipid formulations provide comprehensive support throughout development and production:
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