Dietary Supplement Stability Testing Services
Prove your product's quality over time with FDA-compliant stability & shelf life testing.
Supplement stability testing evaluates how a dietary supplement performs under various environmental conditions — temperature, humidity, and light — over time, following ICH Q1A(R2) protocols to validate that products remain safe, potent, and effective throughout their claimed shelf life.
Qalitex Laboratories specializes in dietary supplement stability testing that ensures your products remain safe, potent, and effective throughout their intended shelf life. Our testing services comply with FDA regulations, follow GMP standards, and support your product's market longevity.
What Is Stability Testing and Why It Matters
Stability testing evaluates how a dietary supplement performs under various environmental conditions — temperature, humidity, and light. We conduct both real-time and accelerated stability studies per ICH Q1A(R2) guidelines, assessing active ingredient potency, microbiological integrity, packaging durability, and organoleptic properties (color, odor, texture).
Shelf Life Testing
Shelf life testing defines how long a supplement remains both safe and effective, providing the data needed for accurate expiration dating. We simulate extended storage under real and accelerated conditions, testing at 0, 1, 3, 6, and 12 months, evaluating degradation of actives and risk of microbial growth.
Our Testing Process
We test a wide range of formats: tablets, capsules, softgels, powders, gummies, and liquids. Every study includes a protocol design phase, appropriate chamber conditions (ICH Zone I–IV), testing intervals, and a final stability report with CoA documentation suitable for FDA submission.
Tests & Methods Included
- ✓ Real-time stability studies
- ✓ Accelerated stability (ICH Q1 conditions)
- ✓ Potency & label claim over time
- ✓ Microbial integrity testing
- ✓ Packaging compatibility
- ✓ Organoleptic evaluation
Regulatory Standards & Compliance
- ICH Q1A(R2)
- FDA Guidance for stability testing
- USP dietary supplement standards
- cGMP 21 CFR Part 111
Industries We Serve
- Dietary supplements (all formats)
- Nutraceuticals
- Functional foods
- Amazon FBA products requiring expiry dating
- Contract manufacturers
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What is the difference between real-time and accelerated stability testing?
Real-time stability testing stores products under normal conditions and tests at intervals over months or years, while accelerated stability testing uses elevated temperature and humidity to predict shelf life faster. Qalitex performs both types per ICH Q1A(R2) guidelines.
How long does a stability study take?
Accelerated stability studies typically run 3–6 months under ICH conditions (40°C/75% RH). Real-time studies run 12–36 months under normal storage conditions. Qalitex tests at 0, 1, 3, 6, and 12 months to track changes in potency, microbiology, and organoleptic properties.
Why do supplements need stability testing?
Stability testing validates that a dietary supplement remains safe, potent, and effective throughout its claimed shelf life. The FDA requires stability data to support expiration dating, and retailers like Amazon require documented shelf-life validation.
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