Stability Studies

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CAL assists your company in designing and executing Stability Protocols.

Stability Testing demonstrates how packaged regulated products are affected by temperature, humidity and light conditions over time. This data is used to establish shelf life and required storage conditions.

Regulated products often require Stability Studies to support assignment of shelf life and as a part of ongoing studies to check manufacturing activities and validate shipping procedures.

CAL’s dedicated Stability team provides services for all stages of product development, from early Research & Development to In-process to Post Approval studies, in full compliance with ICH, FDA and Health Canada requirements.

Stability reports are tailored to your requirements and may include individual test point results, summaries at specified time periods or cumulative data at each study's conclusion.

We offer the following services:

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  • Stability Protocol Design
  • Shelf Life Stability
  • Accelerated and Intermediate Studies
  • Stability testing for IND, NDA, ANDA
  • Formulation Evaluation Stability Testing
  • Forced Degradation Studies
  • Freeze & Thaw Study
  • Formulation Capability Study
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We conform to the current ICH guidelines developed for new regulated substances and products.

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Our storage features include:

  • Reach-in chambers with temperature settings to meet your needs, ranging from Room Temperature to 40°C
  • A variety of humidity settings
  • All storage conditions fully validated and monitored 24 hours/day
  • A routine calibration and maintenance program for all chambers and equipment,including thermocouples and chart recorders
  • Interim reports for every testing period