Analytical Services - Isolation and Characterization of Impurities in Pharmaceuticals

Analytical Services is a service-based partner for the pharmaceutical industry. We have a large number of PhD chemists, meaning we can offer over 25 years of experience to our customers from R&D pharmaceutical companies, biotech-companies, drug substance manufacturers and generic drug manufacturers.

Analytical Services provides services for structure elucidation, isolation and synthesis of degradation products in drug substances and drug products. The qualification of reference standards is done in full compliance with GMP requirements.

STRUCTURE ELUCIDATION OF UNKNOWN IMPURITIES

The structure of impurities – unknown degradation products in drug substances and drug products – must, according to current FDA and EMEA guidelines, be elucidated if they exceed a level of greater than 0.1%.

Analytical Services provides the latest analytical techniques for structure elucidation (e.g. high-field NMR, LC-MSMS, GC-MS, MALDI-TOF) as well as for preparative isolation of unknown impurities (e.g. semi and fully preparative HPLC). Software tools for the prediction of spectra support the work of our experts.

CHEMICAL STRUCTURE SYNTHESIS

Once unknown impurities or metabolites are identified, they need to be synthesised for proof of structure, for qualification as reference standards or for testing their biological activity. Analytical Services provides efficient syntheses of complex chemical structures in a milligram to gram scale.

For the analysis of substances which are only available in low amounts, Analytical Services offers a broad variety of special analytical methods like GC-TCD, micro-Karl-Fischer-titration, TGA, etc.

SUBSTANCE TESTING AND STORAGE

Together with the analytical qualification of a reference standard a certificate of analysis is provided, including the test results, the declared content and the storage information of the reference standard. Reference substances are stored under GMP conditions and distributed worldwide by courier on the customer's demand.

CLINICAL QUALITY CONTROL TESTING

Method development, method validation and release analysis give our customer the full quality-control package needed for clinical studies and filing. Regulatory and quality management support complete the analytical one-stop shop.

METHOD DEVELOPMENT AND VALIDATION

Analytical methods and reliability of data have immediate influence on process development, toxicological and clinical studies as well as on drug approval. For method development, our analytical experts guarantee quick and targeted solutions beyond routine work. Analytical Services provides method validation according to FDA and EMEA guidelines as well as routine testing described in the European Pharmacopoeia.

DRUG QUALITY MANAGEMENT

In the pharmaceutical environment, quality assurance and quality control have to meet the high requirements of authorities and customers. Compliance with current GMP regulations is an important factor for our customers' business success. Implementation of GMP rules in an early-stage development is a balancing act between high flexibility and full compliance. Analytical Services can assist you in all needs of quality management.