Alcami offers stand-alone stability services as well as in-process studies.
Pharmaceutical drug products and active pharmaceutical ingredients (APIs) are significant components of pharmaceutical development and commercial product monitoring. Finding a provider that offers comprehensive stability studies as part of full product development and as a stand-alone service can be difficult. Alcami offers stand-alone stability services as well as in-process studies with the expertise to guide you from the design of the stability study for each phase of development through the evaluation of the data accruing to ICH Q1E.
- In-use studies (broaching, reconstituted product stability, multi-use container stability)
- Formulation development studies including stress studies
- Photostability (Options I and II)
- Comparator studies
- Thermal cycling/freeze thaw
- Shipping excursion studies
- Long-term stability studies
- Accelerated stability studies
Highlights of Alcami's Stability Services
- Electronic stability protocol generation, inventory control, capacity control, and stability pull calendar
- Paperless, barcode-tracked sample submission to the lab with definitive testing instructions downloaded directly to electronic laboratory notebook (ELN) to ensure first time right testing
- Multiple site storage for disaster mitigation available
- Networked sites working under harmonized SOPs providing backup resources for protocol creation, reporting, etc.
- 24-hour chamber monitoring by multiple sensors in each chamber
- Limited access facility, on-site off-hours security in addition to electronic security systems
- Approximately 8,000 cubic feet of stability chamber space across two sites
- Ability to perform studies on Schedule I-V controlled substances