Stability Testing Services

  • GMP stability testing for dietary supplements including project oversight for testing, customized quoting with product evaluations for appropriate marker claims, and complete data compilation for the product.
  • Stability chambers dedicated to the finished product evaluation at accelerated stability and real time conditions.
  • Continual monitoring to ensure proper temperature/humidity controls are met.
  • Expertise in analyzing softgels and understanding the complexities.

Stability is defined as the extent to which a product retains the same properties and characteristics that it possessed at the time of its manufacture, within the specified limits and throughout its period of storage and shelf life in its final packaging format.

Captek provides stability testing services for dietary supplement products. There is a growing need for supplement brands to meet stricter regulatory requirements. Scientific data to support shelf life claims of dietary supplement products has made stability testing necessary.

Softgel dosage forms present a unique case for proper analytics. Captek, a leader in softgel manufacturing, has the unique expertise required with softgel dosage forms.

We Provide the following for product at each time point:

AnalyticalTestingPhysicalAnalysisMicroAnalysisPackagingAssessment

Accelerated Stability

Study conducted under controlled conditions of 40°C (±2°C) with relative humidity at 75% (±5%) with testing performed at specified intervals.

Sampling point/frequency will include the initial testing at (t0), 1 month, 2 months, 3 months, and/or 6 months depending on the study requested.

Real Time Stability

Study conducted under controlled conditions of 25°C (±2°C) with relative humidity at 60% (±5%) with testing performed at specified intervals.

Sampling point/frequency will include the initial testing at (t0, 1 month, 2 months, 3 months,
6 months, 9 months, 12 months, 18 months, 24 months, and/or additional yearly depending on the study requested.

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