Our services at a glance
STABILITY STUDIES (ALL ICH CONDITIONS)
Planning and execution of long-term, intermediate, and accelerated studies in accordance with ICH guidelines to determine shelf life and storage conditions, including evaluation and trend analysis.
STORAGE (ACCORDING TO ICH CONDITIONS AND STRESS STUDIES)
Storage of your samples in climate chambers under defined ICH conditions, as well as targeted stress and transport simulations with seamless monitoring and documentation.
ASSAY
Quantitative determination of active ingredient content using validated methods to ensure dosage accuracy.
PURITY
Detection and quantification of impurities and degradation products in accordance with pharmacopoeial requirements and validated methods.
DISSOLUTION
In vitro dissolution testing according to Ph. Eur./USP to characterize drug release behavior.
PHOTOSTABILITY
Testing according to ICH Q1B to assess light sensitivity and potential light-induced degradation processes.
DISINTEGRATION TIME
Determination of the disintegration time of solid dosage forms in accordance with pharmacopoeial methods to assess product performance.
FRIABILITY
Friability testing to evaluate the mechanical stability and handling robustness of tablets.
PARTICLE SIZE DETERMINATION
Determination of particle size and particle count (e.g. in powders, suspensions, injectables) to ensure product quality.
TABLET HARDNESS
Measurement of breaking strength and friability to control stability and dissolution behavior.
DETERMINATION OF MOISTURE CONTENT
Analysis of water content (e.g. Karl Fischer) to assess stability, flowability, and processing characteristics.
TURBIDITY
Turbidity measurement to evaluate clarity and particulate load of solutions and suspensions.
LOSS ON DRYING
Determination of loss on drying (LOD) according to pharmacopoeial methods to control residual moisture content.
MICROBIOLOGY
Microbiological quality testing, including bioburden, sterility, and endotoxin testing in accordance with applicable standards.
pH VALUE
Precise pH measurement to control stability, solubility, and formulation and compatibility characteristics.
DETERMINATION OF WATER CONTENT (TITRATION)
Titrimetric water determination according to applicable pharmacopoeias. Suitable for solid and liquid matrices (e.g. raw materials, intermediates, and finished products).
DETERMINATION OF WATER CONTENT (KARL-FISCHER)
Volumetric and coulometric Karl Fischer titration according to Ph. Eur./USP for precise and selective water determination.
