Analytical Services
Analytics supporting your innovation process
The complete process from lab development to commercial production is accompanied by state-of-the-art analytics, based on our expertise in developing and validating analytical methods as well as quality control of raw materials and finished products.
We have particular experience in:
Development of analytical methods and validation
Structure determination, specific elemental analyses, dust and air measurements
Quality control of raw materials and finished products
Available Techniques
Chromatography: HPLC/UPLC (e.g. CAD, ELSD, RI, MS), GC (e.g. headspace, MS), SEC, IC (conductivity, amperometric) and TLC
Atomic spectroscopy: AAS, ICP-OES and ICP-MS
Molecular spectroscopy: 1H, 13C, 19F, 31P NMR, UV/VIS, IR/NIR and MS
Elemental analysis: C, H, N, O, S analyser and halogen, sulphur, phosphorus analyses after combustion (Wickbold, Wurzschmitt, Schöniger)
Classical analyses: Gravimetry, titration, KF water determination and polarography
Physico-chemical parameters: Conductivity, density, DTA/DSC, melting point, optical rotation, particle size (PSD), pH, reaction calorimetry (RC-1), surface tension, viscosity
Analytical Services under GMP
Certified in compliance with GMP requirements (e.g. ICH, Ph. Eur., AMWHV)
Quality control tests for batch release of API, raw materials, intermediates, products
Method development and validation
Storage of materials under ICH conditions for short- and long-term stability studies
Packaging material testing
In-vitro dissolution tests on finished dosage forms
Analytical assistance for validation of cleaning procedures
Physical tests on solid preparations
Safety Data determination and evaluation
We conduct testing and deliver safety data determination and evaluation in accordance with key global regulations including GHS and REACH, including:
Sameness test and spectroscopy data
Water solubility, partition coefficients, hydrolysis
Combustibility index
Self-heating in air (wire basket tests)
Thermal stability (DTA / DSC, heat accumulation tests)
Dust explosion capability in a modified Hartmann tube
Flammability and autoignition temperature
Reaction calorimetry and kinetic measurements (RC-1)
Dust and air measurements including sampling
Related Topics
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