Generic Dossiers & Licensing

Analytical Services

With more than 25 years as a high-quality analytics provider, we have a built a team of enthusiastic scientists and support technicians that excel in finding rapid solutions to keep your projects on-track. 

Analytical Chemistry

  • Professional expertise and regulatory qualifications necessary to perform analytical testing of raw materials, bulk materials and finished products
  • Well equipped, state-of-the-art laboratories offering comprehensive testing services according to the pharmacopoeia (e.g. EP, USP, BP, JP) and customer specifications
  • Comprehensive services for QP release testing
Assay and chemical tests
Spectroscopy (UV/VIS, IR, AAS)
Chromatographic tests (HPLC/ UHPLC, GC, TLC)
Physical & physico-chemical determinations:
  • pH
  • Viscosity
  • Melting Point
  • Particle Size
  • Loss on drying
  • Limit tests
  • Heavy Metals
  • Ash
  • Residual Solvents
  • Volatile organic compounds (VOC)
  • Organic volatile impurities (OVI)
Pharmaceutical technical procedures:
  • Disintegration
  • Dissolution
  • Hardness
  • Friability
 

Method development: 

  • Assay testing
  • Dissolution
  • HPLC
  • GC
  • Stability indicating methods

Method validation: 

  • Accuracy
  • Precision
  • Specificity
  • Detection limit
  • Quantitation limit
  • Linearity
  • Range
  • Robustness
  • System suitability test

Stability storage and testing

  • Study design to storage, monitoring, analytical testing and documentation
  • Complete bandwidth of storage conditions in numerous climatic walk-in chambers and climatic cabinets with a total storage capacity of approximately 400 m3
  • Refrigerators and freezers available for storage at lower temperatures and chambers for flexible conditions on client’s request. All storage chambers are fully controlled with 24h/7d monitoring and alert system

Services:

  • Support in designing studies for real time, stress tests and photo stability studies
  • Development and validation of “stability indicating methods”
  • Examination of stability-relevant parameters
  • Storage and management of stability samples
  • Interim reports for every testing period
  • Comprehensive final report

Climatic Zones include:
(according to ICH Guidelines)

  • 21°C / 45% r.h.
  • 25°C / 60% r.h.
  • 25°C / 85% r.h.
  • 30°C / 65% r.h.
  • 30°C / 70% r.h.
  • 30°C / 75% r.h.
  • 40°C / 75% r.h.
  • 5°C, -20°C and -80°C

 

 

Contact

Find out what we can do for you - Contact our Analytics and Microbiological experts directly at:

Daniela Sander - Head of Quality Control, NextPharma Bielefeld

phone +49 521 2083-225

daniela.sander(at)nextpharma.com