Pharmaceutical Products

Pharmaceutical products must meet the highest safety requirements

From active ingredients to finished products, we offer a comprehensive range of analytical and research services for APIs (active pharmaceutical ingredients) and pharmaceutical products. We support our customers in the release of raw materials and finished pharmaceutical products (liquids, capsules, powders or tablets).

With our experienced and highly qualified R&D team, we also support the development, establishment and validation of analytical test methods. In doing so, we act quickly, flexibly and render tailored assistance. That is as well how we take international standards into account and also ensure documentation according to your requirements.

We, the Institut Kirchhoff Berlin, a Mérieux NutriSciences company, are an independent, accredited laboratory. We perform analyses based on Good Manufacturing Practice (GMP), such as testing and documentation of pharmaceutical products. With us, you benefit from the high-level scientific expertise of our global Mérieux NutriSciences network, which also keeps us up to date with international developments.

Our special expertise: Analysis of nitrosamine

Pharmaceutical products and nitrosamine contamination

Nitrosamines are classified as probably carcinogenic to humans. This means that long-term exposure may increase the risk of cancer. Nitrosamines are found in some foods and in drinking water supplies. Although their occurrence in pharmaceuticals is low, it must still be recorded by producers and accompanied by monitoring.

Following product recalls by the FDA due to nitrosamine contamination in 2018, the European Medicines Agency (EMA) ordered a review under Regulation (EC) No 726/2004 in June 2020, providing guidance to pharmaceutical manufacturers on how to avoid nitrosamine contamination in human medicines.

We offer the following tests:

• Tests for different phases of NI evaluation for analytical testing of NAC by: LC-HRMS or GC-HRMS with Orbitrap and/or TOF technology; LC-MS/MS or GC-MS/MS (triple quadrupole technology).
• Development of target methods and validation of high-sensitivity methods.
• Targeted screening by HRMS and/or MS/HRMS (to detect NI without available reference standards).
• Confirmatory testing for method development & validation, quantitative testing aligned to GMP with validated methods for high-risk NI and nitrosation assay procedures – NAP test.

Further special analytics for pharmaceutical products

• Verification of the presence of mineral and vitamin analysis according to specifications to support release testing or stability studies.
• Elemental analysis to test for metallic impurities and implementation of the International Council for Harmonization (ICH) Q3D Guideline for Elemental Impurities
• Analysis of pesticide residues
• Testing for contamination by pyrrolizidine alkaloids and toxins, e.g. (aflatoxins, ochratoxin A)
• Testing according to the European Pharmacopoeia, including microbiological quality (reduced price offer for special requests)
• Analysis of pharmaceutical water
• Packaging analysis of pharmaceuticals

Both primary and secondary packaging for pharmaceuticals must ensure product safety until the expiration date and protect them from environmental influences. We conduct substance migration studies, stability tests and material property analyses to ensure that the packaging fulfills its functions without posing a risk to consumer health.