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Stability Storage & Testing

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.


  • 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 16,000 ft2 of stability chamber space across two sites

  • Ability to perform studies on Schedule I-V controlled substances

  • Multiple building generators


  • 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

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