Elemental, Nitrosamines and Other Impurities Testing

Impurities routine testing of finished dosage forms, and identification of impurities in drug substances, excipients, manufacturing equipment and reagents.

Kymos Group 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 partners.

nitrosamines GC-MS

OUR SERVICES

elemental impurities ICP-MS

Our three-step approach for impurities testing

  • 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

Analytical Serviceprovider

Services

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

Climatic chambers for stabilty studies

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

Analytisches CRO HPLCs

Batch Testing and Batch Release

Our laboratories are GMP certified and we have a partial manufacturer authorization for Quality Control purposes.

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