IriSys Analytical Chemisty and Preclinical Development Services
IriSys’ team of analytical chemists is experienced in
the development and validation of stability indicating methods
to be used to quantitate drug substance purity and percentage drug
content in a dosage form, including impurities and degradation
products. As the analytical method evolves, it is further
used to measure conformity to dosage form specifications including
dissolution, presence of related substances and product stability. IriSys
provides the following analytical chemistry services.
Drug substance characterization
Reference standard characterization
Analytical methods development
Stability indicating method development
Impurity profile generation
Degradation product identification
Analytical methods qualification
Analytical methods validation
Dissolution testing according to USP
Dosage unit analysis for potency, purity and content uniformity
Excipient testing
Physical accelerated stress testing
Chemical accelerated stress testing
Specification development
Chromatographic system development
Identification of conditions required for optimal stability
