Development and validation

We develop and validate test methods for identity testing, assay, purity testing and in vitro dissolution for active ingredients, excipients, intermediates, ready-to-use products and medical devices in accordance with international regulatory requirements and the latest scientific and technical knowledge.

Quality control

In our GMP- and FDA-certified laboratory we conduct analytical testing as part of batch release for active ingredients, medicinal products and drug-related medical devices. We can undertake all your stability testing: storage, analytical testing and stability report as part of ICH studies and follow-up studies.

Development

The active ingredient is at the heart of our risk-based formulation development. Its properties have a critical influence on the quality of the product. In our ultra-modern clean rooms we can also work with highly potent active ingredients. By using statistical design of experiment (DoE) we offer an efficient pharmaceutical development that completely fulfils the requirements of quality by design.

Drug development

Laboratory
Laboratory services

Laboratory services

We are your partner for pharmaceutical analysis and quality control.

Analytical services

Our more than 30 years of experience and our continual quest for improvement ensure we deliver analytical services of the highest level for active ingredients, excipients, medicinal products and drug-related products. In addition to developing and validating analytical methods, batch-release analysis, stability testing and structure determination of unknown substances, our core expertise also include risk-based and solution-oriented customer consultation.

More than 45 employees work in our analytical labs to specifically and efficiently meet your requirements. Our interdisciplinary teams and professional project management ensure complex projects are a success.

We are GMP- and FDA-certified and holds a manufacturing authorisation for the release of clinical and market batches.

Consultation

We advise on analytical ussues for human and veterinary medicinal products, for substance-based medical devices and combination products on the basis of current regulatory requirements.

That includes:

Review specifications, analytical methods and validation reports
Planning and implementation of analytical method transfers and production validations
Gap analysis of analytical and technological documents in the context of the development and authorisation of medicinal product

Active ingredients, excipients, ready-to-use products, medical devices

We handle the entire spectrum of pharmaceutical dosage forms and have extensive knowledge of the influences of the matrix on the availability and stability of active ingredients.

Active ingredients and excipients

We test active ingredients and excipients according to the latest monographs of Ph. Eur., USP and other pharmacopoeias. For new active ingredients and excipients, we develop and validate analytical methods to test for content and purity using cutting-edge analytical technologies. That includes testing of highly potent active ingredients or narcotics.

Ready-to-use products

Our laboratory team has long-standing experience in developing and validating test methods and the use of these methods for different dosage forms.

As part of developing test methods, we place special attention on efficient an robust sample preparation. Our experience includes the most diverse complex matrices such as semi-solid and prolonged-release formulations.

Our comprehensive technical equipment of chemical and physical testing methods allows us to investigate products with chemically defined herbal and biotechnologically active ingredients.

Medical devices

We are specialised in the analytical testing and quality control of substance-based medical devices and drug-device combination products and can draw on our extensive experience in various projects over the past few years.

We develop and validate test methods for identity testing, assay, purity testing and the release of active pharmaceutical ingredients in combination products in accordance with national and international guidelines. As part of the quality control of substance-based medical devices and drug-device combination products, we conduct analytical tests for batch release and shelf life according to defined specifications.

We offer physical–chemical characterisation concepts that are individually tailored to your product and perform the relevant extraction studies in our lab. These are for the tests required according to ISO 10993 as part of biocompatibility requirements.

Technical equipment

Gallery of the technical equipment in our labs: The technical equipment of our laboratories includes chromatographic methods (HPLC, GC, TLC), LC-MS, GC-MS, electrophoresis, ASS, IR, photometry, dissolution, relevant test methods for biological molecules as well as wet chemical methods.

HPLC lab

24 HPLC Alliance systems by Waters

UV/DAD detection
fluorescence detection
refractive index detection
light scattering detection (ELSD, MALS)
conductivity detection
pre- or post-column derivatization

4 Acquity arc Systems

DAD detection

HPLC lab

4 UPLC Aquity systems by Waters

DAD detection
fluorescence detection
mass selective detection
CAD detection

2 HClass systems by Waters

DAD detection
mass selective detection

GC lab

6 GC systems by Agilent

flame ionization detection
mass selective detection
headspace-inection

Mass spectrometry lab

Triple Quadrupole mass spectrometer (TQD Triple Quadrupole) for routine analysis, coupled with UPLC/HPLC
QToF(time of flight) mass spectrometer for structure elucidation through exact molecular mass determination (high-resolution mass spectrometry), coupled with UPLC
5977A MSD Extractor

Electrophoresis lab

Capillary Electrophoresis Sciex ESI 8000
Bioanalyzer 2100

AAS lab

Multi-element analysis with up to 66 elements in the ppm/ppb range using atomic absorption spectroscopy with graphite tube and flame atomizers

AAS by Agilent with flame atomization
AAS by Agilent with graphite tube atomization

Dissolution lab

4 dissolution testers by Sotax, Apparatus 1 and 2 according to Ph.Eur. and USP with manual or automatic sampling
2 dissolution testers by Erweka, Apparatus 1 and 2 according to Ph.Eur. and USP with manual sampling
2 dissolution tester by Erweka with high-head operating mode, with or without extraction cell

Further equipment

HPTLC by CAMAG with autosampler, scanner and visualizer
titration instruments Titrando 888 by Metrohm with autosampler for content determinations and volumetric or coulometric Karl Fischer titration
USB Oven Sample Processor 874 for Karl Fischer titration
equipment for determination of refractive index, density, pH value, osmolality, disintegration
FTIR

Further equipment

1 UV/Vis spectrophotometers
Particle counting spectrometer with an automated parental sampling system APSS-200 LiquiLAZ E20P
Viscosimetry: Ubbelohde type capillary viscometer
Tecan Multimode Reader Infinite 200 Pro