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ICH Stability Studies

Commercial Product Stability Studies & cGMP Stability Testing Meeting ICH Guidelines

ICH Stability Testing is an integral part of Avomeen’s contract biopharmaceutical services and supports clinical trials, IND, NDA, and ANDA applications. Our industry knowledge and experience take the stress out of completing regulatory submissions and post-approval studies.

Avomeen’s Ph.D.-led teams of chemists will develop a customized project to meet your national and regional regulatory needs, and projects can be run under ICH, VICH, and customized non-standard conditions. Additionally, we can provide photostability services per ICH Q1B.

Avomeen can help you prepare your new product for U.S. and international markets with stability testing that meets ICH Q1A standards. Our backup generator-equipped storage chambers are individually monitored and alarmed to ensure that they maintain the proper environmental conditions including temperature and humidity.

We offer cGMP stability testing for:

  • Pharmaceuticals, OTC Products, & Registration Batches
  • Foods & Beverages
  • Healthcare Products & Medical Devices
  • Dietary Supplements
  • Paints & Coatings
  • Cosmetics & Cosmeceuticals
  • Sunscreens & Topical Products
  • Wide Range of Other Commercial Products

Want to know more? Check out our CDER & CDRH Stability Testing Whitepaper.

Pharmaceuticals & Medical Device Stability Testing

  • Active Pharmaceutical Ingredients (APIs)
  • Small & Large Molecule Drugs Across All Dosage Forms
  • Biotechnology (Bio-Molecules/Biologics/Biosimilars)
  • Drug-Device combinations
  • Placebos & Controlled Drugs
  • Clinical Trial Materials (CTM)
  • Investigational Drug Products & Devices
  • Pre-Market Drug Products
  • Abbreviated New Drug Application (ANDA)
  • New Drug Applications

Commonly Asked Stability Questions

Our consultative, responsive scientists will act as an extension of your team throughout the duration of your stability program, and they can help to answer commonly asked questions, including:

  • Why do I need to have stability testing completed to register my product for Good Manufacturing Practice Regulations (GMP)?
  • Can stability testing during the development period improve my overall product quality and shorten my time to market?
  • How can I make my product have a longer shelf life?
  • When does my product loose its efficacy?
  • Why does my competitor’s product stay shelf stable longer than mine?
  • How can I verify the compatibility of my formulation’s components and if they are compatible with the packaging?
  • Is my product degrading over time forming impurities within its formulation?
  • What stability tests do I need to perform for my regulatory submission?
  • What conditions should my product be stored under?

During the stability testing process, our skilled scientists will pull samples of the product at regular intervals over time to verify that the samples are meeting requirements according to the protocol. We utilize advanced instrumentation within our laboratories, which allows our chemists to perform elemental analyses, gas chromatography, liquid chromatography, mass-spectroscopy, microscopy, and molecular characterization to identify thermal/mechanical properties and more.

Our rigorous stability testing services provide crucial data on how pharmaceuticals and Biologics vary over time while under the influence of different environmental conditions, including temperature and humidity. Avomeen’s Photostability services characterize the effects of light on the degradation and efficacy of products. These services  allow us to determine a product’s shelf life and establish recommendations on storage conditions and testing intervals.

When necessary, we can also provide stress testing services to meet ICH Q1A stability guidelines. By exposing your products to high-stress conditions (beyond the conditions established through accelerated stability testing), we can establish degradation pathways and validate analytical procedures for such characterization. This testing can also simulate the harsh conditions your product may encounter during the distribution process, helping us identify potential degradation issues early on so that you can avoid costly product recalls.

Full Stability Program Support

Rely on our industry-leading staff to perform FDA release testing for the latest addition to your product line, including the following cGMP stability analyses:

  • ICH Stability Testing Services
  • Real-Time & Long Term Stability
  • Accelerated Stability
  • Forced Degradation Studies
  • Stress Stability Testing
  • R&D Stability Testing
  • In-Use Studies
  • Photostability
  • Comparative/Comparator Stability
  • Follow Up Stability Testing (FUST)
  • Formulation Evaluation Stability
  • Finished Product Release
  • Cycling Chamber Stability Studies

Analytical stability programs for a drug substance or drug product can also be used for the characterization of impurities, degradants, and changes in Physiochemical characteristics, such as dissolution profiles, disintegration, friability of solid dose products or viscosities and rheology of topical gels and creams. Testing can be performed at ambient temperature, accelerated conditions, intermediate conditions, and long-term storage conditions.

Sample Stability Chambers & Cabinets

We offer ICH, VICH, Cycling, and customized storage conditions:

  • 50ºC / 75% RH
  • 30ºC / 75% RH
  • 25ºC / 40% RH
  • 15 ºC
  • 40ºC / 75% RH
  • 30ºC / 70% RH
  • 21ºC / 45% RH
  • 2ºC to 8ºC
  • 30ºC / 35% RH
  • 40ºC / 25% RH
  • 30ºC / 65% RH
  • 60 ºC -20ºC (Freezer)
  • 40ºC / 20%RH
  • 30ºC / 60% RH
  • 50 ºC -40ºC
  • 40ºC / 75% RH
  • 22 ºC -70 ºC
  • 40ºC / 15% RH
  • 25ºC / 60% RH
  • 20ºC (Ambient) -80ºC (Ultra-Low)
  • Photostability (ICH Options 1 & 2) Specialized Conditions Temperature Cycling & More

Full-Service CMC Support

When you contact Avomeen for pharmaceutical stability testing services, you will be connected to a team of scientists who can answer your questions and develop a customized process that allows your product to meet all regulatory requirements. In addition to sharing all analytical process documentation and data summaries, our team of scientists will deliver clear cGMP reports that allows you to see the full results and data trending.

Let’s work together to achieve your vision

Ready to get started? Click Get a Quote, or talk to an expert first if you’d like help in defining your project scope.