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Laboratory services & pharmaceutical analysis

We are your partner for pharmaceutical analysis and quality control.

Pharmaceutical analysis: range of services

With more than 30 years of experience and our continual quest for improvement, we provide analytical laboratory 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 includes risk-based and solutions-oriented client consulting.

Our analytical laboratories are staffed by more than 45 highly skilled professionels who are  dedicated to meeting your needs in a focused and efficient manner. Our interdisciplinary teams and professional project management ensure the success of even the most complex projects. Our GMP and FDA certifications as well as a manufacturing authorisation for the release of clinical and market batches underline our commitment to quality.

Pharmaceutical analysis: Comprehensive advice from experts

Our consulting services cover analytical issues for human and veterinary medicinal products as well as for medical devices and combination products in accordance with current regulatory requirements. Our services include:

  • Review of 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 products

Laboratory services for active ingredients, excipients, finished dosage forms, medical devices

As experts with many years of experience, we work with the full range of pharmaceutical dosage forms and have extensive knowledge of the effects 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. This includes the testing of highly potent active ingredients or narcotics.

Medicinal Products

Our laboratory team has many years of experience in developing and validating test methods and their application to different dosage forms.

When developing test methods, we pay particular attention to efficient an robust sample preparation. Our experience includes a wide range of complex matrices such as semi-solid and prolonged-release formulations.

Our comprehensive range of chemical and physical test equipment enables us to investigate products containing chemically defined herbal and biotechnologically active ingredients.

Medical devices

As specialists in analytical testing and quality control of substance-based medical devices and drug-device combination products, we can develop and validate various test methods, e.g. for identity testing, content determination, purity testing and the release of active pharmaceutical ingredients in combination products in accordance with national and international guidelines. For quality control, analytical testing for batch release and shelf life are carried out according to defined specifications.

For the tests required as part of the biocompatibility requirements in accordance with ISO 10993, we can offer a tailor-made chemical-physical characterisation concept for your product and perform the extraction studies in our laboratory.

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

HPLC systems

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

Arc Systems

  • DAD detection

HPLC lab

UPLC systems

  • DAD detection
  • fluorescence detection
  • mass selective detection
  • CAD detection

HClass systems

  • DAD detection
  • mass selective detection

GC lab

GC systems

  • 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

  • Dissolution testers by Sotax, Apparatus 1 and 2 according to Ph.Eur. and USP with manual or automatic sampling
  • Dissolution testers by Erweka, Apparatus 1 and 2 according to Ph.Eur. and USP with manual sampling
  • 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

  • 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

     

Contact us. We’re happy to help!

Christiane Wiegand
Quality Control

Phone: +49 7272 7767-2521
Email:

Dr. Sandra Hürtgen
Analytical Development

Phone: +49 7272 7767-2571
Email:

Silvia Öttl
Sales Manager

Phone: +49 7272 7767-2561
Email:

Q&A

What is pharmaceutical analysis?

Pharmaceutical analysis is a specialised field of analysis that focuses on identifying, separating and quantifying substances in pharmaceuticals and their starting materials. It plays a crucial role in the entire drug development process, from the initial synthesis of a drug candidate and its formulation to quality control of the final product and post-marketing surveillance. The main objective of pharmaceutical analysis is to accurately determine the chemical structure and concentration of drugs and their degradation products.

Why is pharmaceutical analysis important in drug research and development?

Pharmaceutical analysis is an indispensable part of drug research and development. Pharmaceutical analysis is concerned with the quality control and assurance of pharmaceutical substances, their starting materials and the resulting end products. Analytical methods and techniques are used to ensure the purity, quality and potency of a drug, thereby ensuring that patients receive safe and effective medication.

Hotline

Monday - Friday

+49 7272 7767-0