Preclinical Development

Analytical Chemistry and Preclinical Development Services

IriSys’ team of analytical chemists is experienced in the development and validation of stability-indicating methods used to quantify drug substance purity and percentage of drug content in a dosage form, including impurities and degradation products. As each 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:

• 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
• Container/closure testing and selection