Impurity Testing
Residual Solvents / Impurities (ICH-Q3C)
- USP<467>, JP<2.46>, EP<2.4.24> (all classes of residual solvents in current chapters)
- Available for headspace injection and Customized method development / validation
Trace Metals (ICH-Q3D)
- Risk assessment of raw materials, APIs, intermediates, formulations and Rapid screening analysis
- High sensitive and quality results using ICP-AES and ICP-MS approaches which are suitable for analyzing ppb level.
Extractables & Leachables (E&L)
Our E&L studies can be designed per guidances of ICH-Q3E, E&L testing for pharmaceuticals and biopharmaceuticals.
It is mandatory to analyze chemical compounds may leach from packaging materials of pharmaceuticals and may be transferred during processing stages. And it is important for formulations directly induced into human body such as injection cyringe, drip bag, and eye drops.
In addition to foreign matters like fine particles, chemical substances including harmful metals, volatile residues, and non-volatile impurities should be analyzed.
We design the most relevant testing protocol based on our knowledge and experience of Extractables and Leachables (E&L) testing accumulated in EU and US over 10 years.
We offer in-house seminar.
Nitrosamine Testing
Traces of N-nitrosodimethylamine (NDMA) found in some sartans active pharmaceutical ingredients (APIs) caused several market recalls. In a later phase, detection of these impurities in other classes of medicine, such as ranitidine and metformin, raised additional concerns about patient safety.
The FDA and the EMA are driving the regulatory review and defining new requirements: temporary limits for most common nitrosamines are currently being set based upon the Maximum Daily Intake; European Pharmacopoeia monographs are also being updated to include new mandatory tests for five sartans.
Eurofins Analytical Science Laboratories, Inc. can perform method development, validation, quantitative testing and/or limit testing of common nitrosamines such as NDMA, NDEA, NMBA etc. using GMP complied analytical equipment.
Eurofins BioPharma Product Testing network of companies can perform screening of several type of nitrosamines.
We support your solvent testing, elemental impurities testing, E&L testing and nitrosamine testing. Please feel free to contact us if you have any questions and requests.