stability

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Stability Never Stops

Pharmaceutical product and Active Pharmaceutical Ingredients (API) 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. 

Learn More About Alcami's Stability Services

Study Types
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  • In-use studies (broaching, reconstituted product stability, multi-use container stability)
  • Formulation development studies including stress studies
  • Photostability (Option 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 SOP’s 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
  • Excess of 25,000 cu ft of stability chamber space across three sites
  • Ability to perform studies on Schedule I-IV controlled substances

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* Up to three methods may be transferred at Alcami's discretion
    **Only valid when stability is stored at an Alcami facility
 
Begin Your Stability Study Now