ELEMENTAL, NITROSAMINES AND OTHER IMPURITIES TESTING

ELEMENTAL, NITROSAMINES AND OTHER IMPURITIES TESTING

Kymos provides Elemental, Nitrosamines and other impurities testing of drug products, substances and other sources in compliance with ICH Q3D guidelines, EMA and FDA LoQs and recommendations. This impurities testing service targets clients interested in routine testing of finished dosage forms in drug products. Or those in need of identifying potential sources of impurities in drug substances, excipients, manufacturing equipment and reagents. We have significant analytical capacity with two ICP/MS and an AAS for elemental impurities plus HS-GC-MS and LC-MS/MS instruments for nitrosamines. The full service includes risk assessments with our strategic partner Azierta. We propose a three-step approach for impurities testing compliant with regulatory requirements:

elemental and other impurities EI_ICP-MS Agilent 7800
  • Risk assessment according to regulatory guidelines
  • Limit test/semi-quantitative screening at default limits or upon client request
  • Quantitative method validation for impurities exceeding established limits

Our impurity services are grouped in two main chapters:

HPLC Waters in laboratory

Related Services

Quality Control of Biologics and Biosimilars

Complex characterization projects for innovative biologics and comparison of biosimilars.

Quality Control of Small Molecules

Analytical tests for APIs, excipients, intermediate products, finished products, packaging materials and process environment samples.

Batch Testing and Batch Release

KYMOS and PHARMAPROGRESS are GMP certified and we have a partial manufacturer authorization for Quality Control purposes.

Stability Studies

Full ICH studies and on-going stability programmes at different storage conditions.

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