Analytical Development

Each of our Center of Excellence for Development is supported by a specialized analytical development team. In addition to standardized techniques for assay, homogeneity and purity, we offer targeted analytical development to support optimal control of raw materials, product quality (identity, strength and purity) and consistent process performance (in process controls) for a wide range of products and processes.

All common pharmacopoeial chemical, physical or biological methods are established either through our in-house analytical capabilities or, if required, through a broad network of qualified contract laboratories.

Our analytical development teams support your project from initial development trials to process validation in full compliance to cGMP requirements, covering:

• Method development
• Raw material testing
• Cleaning validation
• Method optimization
• Forced degradation studies
• Identification of impurities
• Method validation and verification
• Method transfer (also supported from Technology Services & QC labs)
• Stability testing according to current ICH requirements

Our modern laboratories are equipped with a wide range of analytical instruments, such as HPLC, residual solvents determination (GC), residual water determination (Karl Fischer), thin layer chromatography (TLC) and dissolution testing.

Besides standard techniques, we can perform specialized analytics for raw material characterization or attribute testing that is specific for individual dosage forms:

Material characterization

• Morphological evaluation (e.g. digital morphological evaluation or laser light diffraction)

Specialized technologies by dosage form

• Solids: characterization of particle size
• Liquids: suspension settling tests
• Sterile products: microbiological testing in house
• Semisolids: permeability testing