We perform testing according ICH guideline Q3D (R2)

Elemental impurities may arise in raw materials, active ingredients, excipients or in finished medicinal products. To ensure the quality of drug products and patient safety the levels of element impurities have to be determined and quantified according to the above guideline.

ICH Q3D(R2) Guideline for Elemental Impurities is a quality guideline for the control of elemental impurities in drug products, medicinal products, and it establishes Permitted Daily Exposures (PDEs) for 24 Elemental Impurities (EIs) for drug products administered by the oral, parenteral and inhalation routes of administration.

The risk of contamination with elemental impurities can be reduced through process understanding, raw material selection, equipment qualification and established GMP processes.

Our experts have the regulatory know-how and the technical expertise to support you with risk evaluation, method development, method validation, and routine testing - tailored to the specific requirements resulting from matrix, dosage form and manufacturing characteristics.

Our services:

·       Regulatory consultancy

·       Method development and validation (full validation or risk-based approach)

·       Qualitative and quantitative analysis of elemental impurities

·       Routine testing of raw materials, excipients, reagents, active ingredients, process water, catalysts, finished medicinal products etc.

Our equipment:

·       ICP-MS system

·       Microwave digestion system

Our experience with a wide range of sample types and complex sample matrices will be your benefit!

Tentamus Pharma & Med Deutschland GmbH
Columbiastr. 14
Info-TPMD@tentamus.com
97688 Bad Kissigen