Laboratory Services

Stability Testing & Storage

Laboratory Services
Routine & Custom Testing
Stability storage

Stand-alone stability testing services and in-process studies

Pharmaceutical drug products and active pharmaceutical ingredients (APIs) are significant components of pharmaceutical development and commercial product monitoring. It can be hard to find a provider offering comprehensive stability testing studies as part of full product development and as a stand-alone service. Alcami offers stand-alone stability testing services and 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.

Alcami's Stability Testing 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 16,000 ft2 of stability chamber space across two sites

Ability to perform studies on Schedule I-V controlled substances

Multiple building generators

  • Stability Testing 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

Related Topics
Quality by Design: The Importance of Reference Standards in Drug Development
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Summary

Alcami offers specialized stability testing services. Our expertise includes study design, execution, and data analysis to ensure product quality and compliance. With state-of-the-art facilities and robust quality systems, Alcami supports drug development from early stages to commercialization.

Related Topics
Quality by Design: The Importance of Reference Standards in Drug Development
Contact Alcami
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