Analysis of Raw Materials, Active Ingredients and Excipients

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.

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.

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.

We offer you the entire range of services related to the topic of "pharmaceutical glycerol". This includes tests according to EP, JP or USP. In addition, we offer you our help with all analytical questions in addition to chemical, microbiological and testing.

Pharmaglycerin is obtained from crude glycerin by simple, multi-stage processing (distillation, deodorization and filtration) and is commercially available in various purity grades. The 85% and 100% quality grades are specified in the pharmacopoeias with different purity criteria.

We can offer you the complete pharmaceutical-grade glycerol analytics according to all common pharmacopoeias.

• Examination according to monographs
• • Properties
  • Identities
  • Degrees of purity
  • Water
  • Related substances and impurity A
  • Diethylene glycol and ethylene glycol
  • Content determination
• Heavy metals screening using ICP-MS (ICH Q3D, USP, EP)
• Viscosities (capillary viscometry and rotational viscometry)

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.

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.

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.

For many years, Eurofins BioPharma Product Testing network of laboratories has been dedicated to the analysis of dioxins, PCBs and other persistent organic pollutants (POPs), making it the world's leading dioxin laboratory. We combine state-of-the-art technical equipment with the necessary expert knowledge under one roof.

The applied methods are based on US-EPA standards. The analysis of dioxins and furans is carried out using the isotope dilution method (to 2x HRGC/HRMS).

The GMP laboratory is subject to cGMP inspections by the US FDA (last inspection in July 2013: no findings) and by the German authorities in accordance with § 64 of the German Medicines Act (AMG).

Parameters

• Polychlorinated dibenzo-p-dioxins/furans (PCDDs/Fs)
• Dioxin-like polychlorinated biphenyls (dl PCBs)
• Non-dioxin-like polychlorinated biphenyls (ndl PCBs)
• All polychlorinated biphenyls (209 PCBs)
• Polybrominated diphenyl ethers (PBDEs)
• Heavy metals
• Pesticides
• PAHs

Matrices

• Fish oils
• Cod liver oil
• Omega-3 ethyl ester
• Omega-3 triglycerides
• Fish oil capsules with omega-3 fatty acids
• Active Pharmaceutical Ingredients (APIs)
• Pharmaceuticals

Eurofins BioPharma Product Testing Germany 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.

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

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 Germany 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.