Stability Testing & Storage Services

(cGMP Stability Testing Meeting ICH Guidelines)

ICH Stability Testing is an integral part of Avomeen’s contract pharma services and supports clinical trials, IND, NDA, and ANDA applications. Our depth of knowledge and industry experience takes the stress out of completing regulatory submissions and post-approval studies. Avomeen’s backup generator equipped storage chambers are individually monitored and alarmed to ensure that they maintain the proper environmental conditions including temperature, lighting, and humidity. We will help you develop a customized project that will meet your regulatory needs and can run projects under ICH, VICH, and customized non-standard conditions.

Avomeen offers cGMP stability testing for:  

  • Pharmaceuticals
  • ANDAs- Registration Batches
  • Foods & Beverages
  • Healthcare Products & Medical Devices
  • Cosmetics & Household Products
  • Finished Products
  • Bulk Production Batches
  • Wide Range of Other Commercial Products

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

Pharmaceuticals & Medical Device Stability Testing:

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

Avomeen’s Stability Laboratory Can Answer 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?
  • How can I verify the compatibility of my formulations components and if it is compatible with its packaging?I
  • Is my product degrading over time forming impurities with its formulation?
  • What stability tests do I need to perform for my regulatory submission?

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 its protocol. We utilize state-of-the-art instrumentation within our segmented laboratories which allow our chemists to perform elemental analyses, gas separation, liquid separation, microscopy, molecular characterization, to identify thermal/mechanical properties 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 allows a product’s shelf life to be determined, as well as the establishment of recommendations on storage conditions and re-testing intervals.

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 can also be used for the characterization of impurities and degradations, in line with dissolution studies, and to determine the products hardness, its residual solvents, disintegration, and friability. 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
  • 40ºC / 25% RH
  • 30ºC / 65% RH
  • 60 ºC -20ºC (Freezer)
  • 40ºC / 20%RH
  • 30ºC / 60% RH
  • 50 ºC -40ºC
  • 40ºC / 75% RH
  • 30ºC / 35% 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:

Take advantage of our offer of a complimentary initial consultation with one of our Ph.D. chemists