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Analysis of Active Ingredients and Excipients

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Analytics for your raw material release and supplier qualification

Eurofins offers you the complete range of services around the analysis of active ingredients and excipients. Whether you need support with the release of your raw materials for production or for the qualification of your suppliers - we can help.

The testing of complete monographs, whether properties, identities or purity and content, is routine for us. For the analysis we have a variety of instruments at our disposal, including IR, UV, polarimeter, refractometer, densitometer, Kjeldhal, HPLC, GC, Karl-Fischer, Brookfield viscometer, AAS, ICP-MS.

In addition to chemical, microbiological and physical analysis according to the methods of common pharmacopoeias or according to your methods, we offer consulting for analytical questions.

 

Why Eurofins BioPharma Product Testing?

We are the world's largest network of harmonized GMP laboratories for testing bio pharmaceuticals. In our 22 laboratories with a total of over 63,000 square meters of laboratory space and more than 2,700 employees, we are at your side as a full-service provider.

We regularly exchange our expertise in various expert rounds, so that we can find a quick solution for every problem.

In addition to testing raw materials, we also offer testing of finished drugs, intermediates and starting materials for both small and large molecules.

 

Validations / Method development

Method transfer, method verification or validation according to ICH Q2 guidelines as well as method development are also possible. We have experts available worldwide in all areas who communicate closely with each other on complex issues and find the perfect solution to your problem as quickly as possible.  

 

Residual solvents

The examination for residual solvents according to ICH Q3C, EP or USP is carried out routinely 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.

 

Heavy metals

You can choose between a limit value test or a test using GAAS, FAAS or mercury analyser. Of course, we also offer testing using ICP-MS according to the specifications of ICH Q3D, USP or Ph. Eur. and will be happy to advise you here.

 

Mikrobiology

Do you also need testing for germs and pathogenic germs? No problem, our microbiology is specialized in the examination of raw and auxiliary materials according to EP or USP.

 

Stabilities

Whether for a pending approval or as an "Ongoing Study", in Hamburg we offer you the following conditions:

Long-term: 25°C/60%

Intermediary: 30°C/65%

Accelerated: 40°C/75%

Cooling: 5°C


In line with this, the quality parameters after outsourcing can be examined directly at the site.

If your product requires further conditions, we have a large number of climatic conditions available in France and Sweden on a storage area of approx. 2,300 sqm. Please ask us for a current list.

 

Characterization of organic substances

You need a characterization of your pure organic substance? If so, the Eurofin network offers all common characterization methods such as IR, UV/VIS, mass spectrometry, NMR (1H, 13C, 31P), XRD and elemental analysis (C, H, O, S, N) under GMP.

 

Exclusive equipment

Surely there are some special tests, which you cannot carry out in your laboratory. In our group you will also find the unusual methods at your disposal:

  • HPLC-PAD/ELS/RI/MS
  • (Capillary) electrophoresis
  • Amino acid analyzer
  • SEC
  • SFC
  • GPC
  • IC


Pharmacopoeias

We always analyze according to the latest version of Ph. Eur., USP or FCC. If you miss a test, because the monograph has changed, we can additionally fall back on a well maintained archive. In addition to 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.

 

Quality

We have been GMP certified for over 20 years. An incoming sample is first checked for integrity and storage conditions and registered in the Lims system. From this point on, each sample vessel is unmistakably marked with a barcode. Each step is of course carried out in accordance with the 4-eye principle. Upon request, we will gladly send you our template for a VAV.

 

Please contact our team of experts for further information.