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Stability Testing

Looking For a Stability Testing Partner?

Q Laboratories offers a wide range of expertise and personalized service

At Q Laboratories, we have extensive stability testing capabilities to support your product development and formulation needs. In addition to a mutiltude of analytical and microbiological test offerings, we also have a large team of scientists and laboratory professionals available to provide you with personalized service and attention. We specialize in stability testing for products meant for human use such as:

  • Pharmaceuticals
  • OTC’s
  • Personal care products
  • Cosmetics

ICH Guidelines

When it comes to pharmaceuticals, the stability of drug substances is required testing through The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH helps establish the universal set of quality standards in the pharmaceutical industry.

Stability testing is important and helps determine factors such as:

  • Shelf life
  • Retest periods
  • Optimal storage conditions

Q Laboratories stores stability test samples in ICH compliant humidity and temperature-controlled chambers.

Why Is It Important?

Stability testing is important for a variety of reasons. Not only does it help determine critical factors about a product to promote quality, but it can also help determine optimal storage conditions for a given substance – providing valuable insight to ideal product packaging and label instructions.

Types of Stability Testing (Long term, accelerated, freeze/thaw, thermal cycle)

Stability testing subjects a substance to a variety of environmental conditions to determine if the compound may change in a harmful way to the consumer. Since it is unlikely for a product to stay in the exact same environment it was created in for its lifetime, it’s extremely important to test that product.

Other important discoveries during a stability test are the retest period, or the time in which the product should be subjected to stability testing again. This time period establishes the time frame the substance is expected to remain within its required quality specification to be used in the manufacturing of a drug product. Once a retest period has elapsed, a substance is required to meet acceptance criteria before being used in a product for consumer use. Learn more here.

Arguably, the most important outcome for stability testing is determining overall quality & safety for consumers over the lifetime of the product.

What Are The Types? (Long-term, accelerated, freeze/thaw, thermal cycle)

Since Stability Testing can be conducted on a range of products and substances, in a range of environments, there are a variety of tests that can be performed. Some of the types of tests we do are:

  • Identification tests
  • Physical tests
  • Assays
  • Microbiological tests
  • Weight loss
  • Preservative effectiveness tests 

Prior to any study, acceptance criteria are established. Quality is key, so it’s important to ensure an accurate test to ensure reliable results.

Q Laboratories is Your Partner

Whether you are a novice or tenured professional in the world of stability testing – Q Labs is here to help! We provide dedicated stability resources to support our clients from the beginning of protocol development all the way through study completion, making us the perfect partner for your next stability testing project.

Our state-of-the-art facilities offer complete analytical, microbiological, and sensor testing capabilities. Our capabilities include:

  • 24-hour continuous chamber monitoring: ensures your test results are not only dependent on your protocol, but are secured and reliably accurate 
  • Real time to accelerated conditions: you have complete flexibility in determining your test conditions at Q Laboratories 
  • ICH guidelines: our chambers are compliant with ICH guidelines
  • A range of custom chamber capacities: meets any project need, we are able to develop and deliver complete studies to meet your client needs
  • Expertise: in pharmaceuticals, personal care, over the counter products, and cosmetic testing
  • Guaranteed to deliver: Q Labs is guaranteed to help you deliver on your project!

Contact us today for help with stability testing, designing a study, creating a study protocol, or for additional information about our types of stability testing.

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