|
Analytical chemistry Exemplar's analytical chemistry group serves as an extension of your R&D analytical and quality control laboratory. Utilizing our extensive and sophisticated analytical instrumentation, Exemplar's researchers 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 and stability assessment.
|
|
Analytical services
- Method development and validation
- Process validation and cleaning validation
- Drug substance characterization
- Reference standard certification
- Drug substance and product lot release
- Impurity profiling, isolation, characterization
- Excipient analysis
- Method and product troubleshooting
Available programs
- Long-term and accelerated storage conditions
- Program design and management
- Protocol development
- Statistical analysis and data trending
|
|
|
Stability programs Exemplar offers comprehensive stability programs for drug substances, formulation evaluations, clinical supplies, and commercialized finished products. Our cGMP facilities are equipped with fully mapped stability chambers, each of which is independently controlled and monitored with redundant alarm systems. Our services include on-time testing and customized report generation.
In vitro BA/BE testing Exemplar is regularly in touch with the FDA regarding the interpretation of FDA guidances that control various aspects of both CMC and BA/BE requirements.
- Protocol development
- NDA required in vitro BA testing
- ANDA required in vitro BE testing
- Report generation in FDA submittable format
- Statistical analysis in FDA submittable format
|
|
Copyright © 2008 Exemplar Pharmaceuticals, LLC, a subsidiary of Exemplar Pharma, LLC. All rights reserved.
Exemplar Pharmaceuticals, LLC, 200 Riggenbach Rd, Fall River, MA USA 02720, Phone 508-676-6726, Fax 508-676-6546, Contact Exemplar via the Internet.
|
