Stability Testing & Storage Services

(Commercial Product Stability Studies & cGMP Stability Testing Meeting ICH Guidelines)

ICH Stability Testing is crucial for clinical trials, IND, NDA, BLA and ANDA applications and an integral part of Avomeen’s contract testing services. Our in depth knowledge of regulatory pathways and extensive industry experience takes the stress out of completing these studies. Avomeen’s cGMP storage chambers ensure maintenance of the proper environmental conditions including temperature, humidity, and lighting. We will help you develop a customized protocol that will meet your national and regional regulatory needs, and we can run projects under ICH, VICH, and other customized conditions.  With stability testing that meets ICH Q1A standards, we can help you prepare your new product for a U.S. and international market.

Avomeen offers 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

 


FDA-Registered, DEA-Licensed (Class I-V), GLP/GMP-Compliant, and ISO 17025-Accredited Facility

Our pharmaceutical stability testing will help you avoid regulatory delays so that you can bring your products to market earlier


Medical Device & Pharmaceutical Stability Testing:

  • Active Pharmaceutical Ingredients (API’s)
  • Small & Large Molecule Drugs Across All Dose Forms
  • Biotechnology (Bio-Molecules/Biologics/Biosimilars)
  • Combination (Drug-Medical Device) Products
  • Placebos & Controlled Drugs
  • Clinical Trial Materials (CTM)
  • Investigational Medical Products & Devices
  • Pre-Market Drug Products
  • NDA, BLA, Abbreviated New Drug Application (ANDA)

Avomeen’s Stability Testing Laboratory Can Answer Complex Questions Including:

  • Why do I need to have stability testing completed to register my product for 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 formulations components and if it is compatible with its 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 chemists will take pulls at regular intervals over time to verify the samples are meeting their requirements according to the defined protocol. We utilize advanced instrumentation within our segmented laboratories, which allows our chemists to perform tests such as elemental analyses, volatile and semi-volatiles analysis, non-volatiles analysis, physical properties, molecular characterization, and more.

This type of testing develops crucial data on how pharmaceuticals and other products vary over time while under the influence of different environmental conditions including temperature, humidity, and photostability. This also allows a product’s shelf life to be determined, as well as the establishment of recommendations on storage conditions and re-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 our analytical procedures. 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.


Call on Avomeen’s experienced staff to perform FDA release testing for the latest addition to your product line, including the following cGMP stability analyses:

  • ICH Stability 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 also can be used for the characterization of impurities and related substances in line with dissolution studies, and to residual solvents, disintegration, and friability. Testing can be performed at ambient temperature, accelerated conditions, intermediate conditions, and other 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

Avomeen’s full-services laboratory can help you solve your most complex product development and analysis questions, our other related services include:

When you contact Avomeen for pharmaceutical stability testing services, you’ll be connected to a team of Ph.D. chemists who can answer your questions and develop a custom process that allows your product to meet all regulatory requirements. In addition to sharing all analytical process documentation and raw data, this team of scientists will deliver a clear report that allows you to see the full results of their testing.

Take advantage of our offer for a complimentary initial consultation with one of our Ph.D. chemists or request a quote today