Analytisches Zentrum Biopharm - Analytical Services for Human and Veterinary Pharmaceuticals

The Analytical Centre of Biopharm, Berlin (Analytisches Zentrum Biopharm Berlin, AZB) is a German contract research organization providing services on pharmaceutical analysis and bioanalysis for active compounds in the dosage form. We can quantitativly determine analytes in a biological matrix and also physicochemical parameters of intermediates in the chemical industry, according to OECD guidelines.

AZB carries out these services in compliance with GLP and GMP and has the GLP certificate for test category 1 (physicochemical studies and assay) and category 8 (analytical studies on biological materials).

Stability studies of medicinal products and active compounds

AZB carries out stability studies in accordance with ICH, also on active compounds which are subject to the Addictive Drugs Act. Our programme includes not only development and validation of methods indicating stability of content and purity, but also the deposition of test samples under ICH conditions.

We have experience not only of human pharmaceuticals (solid and semisolid oral dosage forms, liquids, suppositories), but also of veterinary pharmaceuticals (powders, solid oral dosage forms). Analysis is carried out according to the clients' test protocols and also according to our own test protocols. Deposition, control of storage conditions and analysis are organized and documented in compliance with GMP. The test means used are qualified and are subject to the lifetime model.

Quantitative determination of active compounds for Bioanalysis / human pharmaceuticals

AZB has many years’ experience in the quantitative determination of active compounds in a biological matrix. About 150 methods have been developed and validated for determining active compounds in plasma and urine. Analytical techniques available for this are HLPC with UV, fluorimetric and electrochemical detection, LC/MS, LC/MS-MS and GC/MS. The methods are validated according to Guidance for Industry: Bioanalytical Method Validation.

Quantitative determination for active compounds for Bioanalysis / veterinary pharmaceuticals

AZB has many years experience in the quantitative determination of active compounds in edible tissues and milk of farm animals. The analytical methods are developed taking into account the relevant directives. Routine analysis is carried out using calibration in the relevant biological matrix, accompanied by a sufficient number of quality control samples.

Analytical methods available are the techniques mentioned above. Quantitative determination of analytes in plasma of farm animals and also quantitative determination in medicated feed or milk replacers, or in the context of proof of stability, are likewise possible.

Determination of physicochemical properties of intermediates

AZB carries out the determination of physicochemical properties of intermediates of the chemical industry under GLP in accordance with OECD guidelines.

AZB has an independent quality assurance unit under GLP guidelines. The quality assurance system is officially certified and has been assessed in numerous audits and accepted with no significant findings.