Analysis of Raw Materials, Active Ingredients and Excipients (GMP) at Eurofins BioPharma Product Testing DACH
Our passion - raw material testing!
No (bio-)pharmaceutical product can be manufactured without first determining the identity, purity and quality of its starting materials to ensure that the product is suitable for its intended use. If this critical step in the (bio-)pharmaceutical manufacturing process is successfully completed, costly production problems and delays can be avoided for you.
Eurofins BioPharma Product Testing Network of Laboratories has the wide range of know-how and state-of-the-art tools required to carry out all types of raw material testing, including the qualification of pharmacopoeia methods as well as the development, qualification and validation of new methods. No matter whether you need support in releasing your raw materials for production or for the qualification of your suppliers - we can advise and support you at the highest quality level.
Our analytics offer for you, some examples
Complete analysis according to pharmacopoeia specifications
We work worldwide with validated methods of the European Pharmacopoeia, EP, United States Pharmacopeia, USP, Japanese Pharmacopoeia, JP, British Pharmacopoeia, BP and ACS, FCC. If you miss a test because the monograph has changed, we can also fall back on a well-maintained archive. In addition to the conventional pharmacopoeias (including DAB, DAC, BP, JP), our library also contains the less common ones such as Chinese Pharmacopoeia, Ayurvedic Pharmacopoeia, Homeopathic Pharmacopoeia, Pharmacopoeia Helvetica.
Complete analysis of monographed amino acids
Among other things, the determination of impurities with automated HPLC UV amino acid analyzers is one of our competencies. The EDQM has updated the relevant monographs by replacing the TLC method with a method for "ninhydrin-positive substances" and "ammonium". These methods allow an accurate calculation of amino acids impurities (caused by other amino acids), as well as a useful estimation of the content of ninhydrin-positive substances. Our analytical methods correspond exactly to the required EP monograph, analysis method 1, according to EP 2.2.56 and at the same time enable compliance with the specifications in EP 2.2.46.
Examination for residual solvents
according to ICH Q3C, EP or USP is routinely carried out by us. For this purpose, we have a large number of GCs with headspace and liquid injectors and FID as well as several GC-MS systems at our disposal.
Water determination according to Karl Fischer
Karl Fischer titration has become one of the most widely used techniques for determining the water content in a variety of substances. Many pharmaceutical products contain water in adsorbed form, which is why determining water content is important to demonstrate compliance with regulatory standards.
Trace Metals see also Trace Metals
The importance of screening for trace metal contamination (Trace Metals) is becoming increasingly important for the safety of bio-/pharmaceutical products. Eurofins BioPharma Product Testing DACH, in conjunction with our global network, offers almost all tests for the detection of metals and for a variety of applications that contribute to product safety, including active ingredient and raw material testing, cleaning validation, media screening, extractable/leachable studies and final product testing.
Raw material testing for biologics
Evaluating the quality and efficacy of materials used in bioprocesses is crucial in the production of biologics. There are many factors that make testing particularly difficult, including the variety of materials used in bioprocesses, different manufacturing approaches, and specific quality assurance control strategies.Eurofins BioPharma Product Testing DACH is well-versed in assessing the identity, purity, efficacy and quality of a variety of materials used in a wide variety of bioprocesses, using established GMP methods as well as tailor-made methods developed for individual customer needs.
Aflatoxin testing
Aflatoxins are a group of mycotoxins and are natural substances produced by moulds and fungi that show toxic effects on humans and animals even in low concentrations. Over 20 naturally occurring aflatoxins are known, of which the aflatoxins B1, B2, G1, G2 and M1 are found in food. Typical food and feed are corn, rice, nuts, figs and other dried fruits or spices. Aflatoxins can also be very dangerous for people with weakened immune systems and therefore testing for aflatoxins in cannabis is a required test.
Contact us if you need to determine aflatoxins in your product.
Harmonised microbial limits testing
Eurofins BioPharma Product Testing DACH offers microbial limit tests that may be required for some raw material analyses, so that customers can have the complete raw material tests carried out by us. Our global teams, working in state-of-the-art controlled and HEPA-filtered microbiological laboratory facilities, have the necessary scientific expertise to quickly and effectively complete projects with microbial limit determinations.
Characterization of organic substances
Do you need a characterization of your pure organic matter? Then, in addition to all common characterization methods such as IR, UV/VIS, mass spectrometry, NMR (1H, 13C, 31P), XRD and elemental analysis (C, H, O, S, N) are also available to us in the Eurofins network under GMP. If you are interested in the analysis of organic pollutants, please visit the corresponding topic pages.
Furthermore, we offer you
- Elemental analysis
- Thermodynamic properties
Method Development and Method validation for Raw Material Testing
Method transfer, method verification or validation according to ICH Q2 guidelines as well as method development are of course also possible with us. For this purpose, we have experts in all areas at our disposal worldwide, who communicate closely with each other on complex issues and to find the perfect solution to your question as quickly as possible.
Quality, sample processing, Eurofins LIMS and LabAccess.com
As GMP-certified service laboratories, adhering to the highest quality standards is our daily goal so that you receive high-quality analysis results from us. An incoming sample of your product is first checked for integrity and storage conditions and registered in our in-house Eurofins BioPharma Product Testin LIMS. From this point on, each sample vessel is unmistakably marked with a barcode. Each step is of course carried out in compliance with the 4-eye principle. On request, we will be happy to send you our template for a VAV.
LabAccess.com, the secure and innovative online data access tool from Eurofins BioPharma Product Testing Network of Laboratories, gives you access to comprehensive laboratory information at any time during your ongoing project. With LabAccess.com, you can view information such as submitted samples, analyst noties, chromatograms, approved test results, certificates of analysis, raw data packages, and invoices online. 24 hours a day, 7 days a week.
Please contact our team of experts for further information.
