Chemical
Adept’s experienced team of analytical chemists in the field of development and validation of stability developed methods to be used to quantitate drug substance purity and percentage drug content in a dosage form, including impurities and degradation products. The method is further used to measure conformity to dosage form specifications including dissolution, presence of related substances and product stability.
Adept provides the following analytical chemistry services.
- Reference standard characterization
- Drug substance characterization
- Analytical methods development
- 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
- Stability indicating method development
- Impurity profile generation
- Specification development
- Chromatographic system development
- Identification of conditions required for optimal stability
- Container/closer testing and selection
- Degradation product identification