Stability Testing Services

Stability Testing

Under ICH Q1A guidelines, adopted by the FDA and EMA, stability testing is intended to demonstrate how the quality of a drug substance varies with time under a variety of environmental stresses. Stresses that are commonly used for stability testing include temperature, humidity, and light.

Stability testing is also used as a verification process for packaging and packaged goods. It can also establish a re-test period for active pharmaceutical ingredient or a shelf life for the medicinal product and recommended storage conditions.

For a limited time we are offering two months free if you book for one year. Learn more.

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Our Stability Testing Services

Our test laboratories provide stability testing for the medical, personal care and pharmaceutical industry. With years of experience performing stability testing service, we are available to test or store a wide range of products in specific temperature and/or humidity conditions.

Applications include, but are not limited to; stability testing, accelerated aging, packaging, life science, biomedical storage and research.

We are able to accommodate large products or large batches of products for stability testing in one of our walk-in test chambers.

Stability Testing Capabilities

Temperature Range:	-20°C to 60°C, -4°C to 60°C
Humidity Range:	10% to 95% RH

Test Specifications
Products Tested

Test Specifications

The following are a few of the common specifications that require the use of temperature and humidity testing. Tests may also be adapted to your specific needs, view full list of specifications

ICH Q1A - Stability Testing of New Drug Substances and Products

This guidance is intended to define what stability data package for a new drug substance or drug product is sufficient for a registration application within the three regions of the European Union (EU), Japan, and the United States. It does not seek to address the testing for registration in or export to other areas of the world. The guidance exemplifies the core stability data package for new drug substances and products, but leaves sufficient flexibility to encompass the variety of different practical situations that may be encountered due to specific scientific considerations and characteristics of the materials being evaluated. Alternative approaches can be used when there are scientifically justifiable reasons.
- (Source: ICH Q1A (R2) November, 2003)
- Document available on ICH web site: http://www.ich.org