Analytical Chemistry
Exemplar's analytical chemistry group serves as an extension of our clients' R and D analytical and quality control laboratories. Utilizing our extensive and sophisticated analytical instrumentation, Exemplar's scientists provide method development and validation services from bulk drug to final product including identification and quantitation of related substances, impurities, degradants and excipients for lot release, product performance and stability assessment.
Analytical services
- Analytical and in vitro method development and validation
- Cleaning validation
- Drug substance characterization
- Reference standard certification
- Drug substance and product lot release
- QC Testing
- Impurity profile, isolation, characterization
- Excipient analysis
- Method and product trouble-shooting
Available programs
- Protocol development
- Customized stability programs
- Shelf life/accelerated or customized storage conditions
- Program design and management
- Freeze/thaw testing
- Statistical analysis, expiration dating and data trending
- In vitro BA/BE Testing