Analytical service along the value chain

From method development and transfer to commercial analysis of raw materials (active pharmaceutical ingredients and excipients), finished goods or packaged goods, we offer all the analytical services you need. To fulfill our ambition to be a full-service contract developer and manufacturer, we have a large analytical department with experienced experts.

Excellence in analytics

With over 180 highly trained laboratory technicians, scientists and project managers, we ensure analytical support for your products. We have many years of experience in method development and validation as well as in raw material and finished product analysis of commercial products. Active pharmaceutical ingredients and excipients are analyzed according to monographs or your dossier.

The planning, design as well as the performance of stability studies is of course also part of our range of services.

In the area of development and analysis of material for clinical studies, our Analytical Technology department works very closely with the development department.

In the area of commercial finished product analysis, we have an extensive equipment park that covers all standard technologies. Special procedures are performed by selected partner laboratories.

180 experts

take care of all analytical tasks

Services

To meet your outsourcing requirements, we have a modern control laboratory with highly qualified experts who take care of all analytical tasks for your products.
 

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Services in detail

  • Release analysis of starting materials (Active pharmaceutical ingredients and excipients, packaging materials)
  • Release analysis of finished products
  • Development of new analytical methods
  • Development-supporting analytics
  • Optimization of existing analytical methods
  • Validation of new and existing methods
  • Transfer of analytical methods
  • Performance of stability studies

What distinguishes us as a CDMO

In the cooperation with our customers, they are in the center of our activities from the very beginning. In addition to the high technical competence of our employees, we rely on our service concepts TPO©, TTM and TSI in the analytics.

Together with our special corporate structure, we generate significant added value for our customers.

Every product passes through a well-structured and documented quality process. All employees are highly trained and can take over all analytical tasks from our customers.

Dr. Christina-Ritter-Sket, Director Quality Control

Benefits

Highest analytical competence
Analytics
Highest quality standards
Analytics
Cross-divisional cooperation
Analytics
Highest analytical competence
Analytics
Highest quality standards
Analytics
Cross-divisional cooperation
Analytics
  • Own training center for laboratory technicians with associated academy
  • Highly committed scientists with great expertise in analytical method development and validation
  • Close integration between analytical technology and routine analytics
  • Standardized and efficient laboratory processes for routine analysis
  • GMP and FDA certified environment
  • Specialized technology-based process groups 
  • State of the art equipment ensured by own operating engineers
  • Close interaction between development, production, analytics
  • True one-stop-shop philosophy due to physical proximity between the divisions 

Technologies

  • Dissolution
    • Erweka and Agilent, Apparatus 1 AND 2 (EP/USP), manual sampling: 10
    • Sotax, Apparatus 1 AND 2 (EP/USP), semi-automated sampling: 4
    • Sotax, Apparatus 2 (EP/USP), fully-automated sampling: 1
    • Detection UV & LC UV: 3
  • Karl Fischer
    • Metrohm volumetric: 2
    • Metrohm volumetric + coulometric with oven: 1
  • HPLC
    • Waters & Agilent: 45
  • H-Class
    • Waters: 10
  • GC
    • Agilent Liquid Injection / Headspace with FID: 4
  • ICP - OES
    • Spectro Blue: 1
  • TLC
    • Camag: 4
  • IR
    • ThermoFischer Scientific IR: 2

Equipment list 
Download the current overview of our technologies.

Download PDF

Contact

Contact us, or use our contact form to get in touch with us. No matter which way you choose, we are here for you and answer your questions!

Contact form

Jean-Luc Yigit

Senior Business Development Manager

+49 (0) 2524 268 0
contact(at)rottendorf.com

Contact

We are at your disposal 
for any questions

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