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. 


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Study Types
  • 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

Stability Services Offered at Alcami

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
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