ISO 17025 认证

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.

检测项目与方法

✓ Real-time stability studies
✓ Accelerated stability (ICH Q1 conditions)
✓ Potency & label claim over time
✓ Microbial integrity testing
✓ Packaging compatibility
✓ Organoleptic evaluation

法规标准与合规性

ICH Q1A(R2)
FDA Guidance for stability testing
USP dietary supplement standards
cGMP 21 CFR Part 111

服务行业

Dietary supplements (all formats)
Nutraceuticals
Functional foods
Amazon FBA products requiring expiry dating
Contract manufacturers

ISO 17025

申请报价

价格因产品而异。告诉我们您的需求，我们将在 24 小时内通过邮件发送详细报价。

申请报价 →

📍 尔湾 · 圣地亚哥，加州

⏱ 2–12 weeks 交付

🌍 全球客户

其他服务

常见问题

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.

专项检测页面

Stability Testing for FDA compliance

stability testing supplements for FDA compliance

Stability Testing for Amazon listing approval

stability testing supplements for Amazon listing approval

Stability Testing for Regulatory submission

stability testing supplements for regulatory submission

Stability Testing Near Irvine & San Diego, CA — ISO 17025 Accredited Lab

stability testing supplements near me

Stability Testing for Product launch

stability testing supplements for product launch

Stability Testing for Quality control

stability testing supplements for quality control

浏览全部检测页面 →

为什么品牌选择 Qalitex 进行 supplement stability testing

⏱️

48 小时交付

签名 CoA 在 48–72 小时内

🔬

直接对接科学家

与负责您检测的化学家直接沟通

🤝

无最低订量

1 个或 100 个 SKU — 同等品质

Cosmetic Testing

准备好检测您的产品了吗？

告诉我们您需要检测的内容。我们将在 24 小时内回复并提供价格和交付时间。