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  Stability Storage and Testing Services  

MRL offers stability programs that are custom designed to meet your stability requirements. In conjunction with your QA department, we will design and administer a stability protocol to meet your regulatory filing requirements. MRL has a full complement of stability support services, which includes forced degradation studies, stability indicating and stability specific analytical method development and validation as well as raw material testing.

Stability Program highlights:

  • Fully validated chambers according to FDA and ICH guidelines
  • On-site stability storage as a stand alone service or combined with analytical support
  • Electronic environmental controls which meet standard specifications
  • Protocol Design, execution of protocol, data analysis, and final report for regulatory submission
  • Forced degradation and photostability studies

Stability chambers are available at the following conditions:

  • Freezer -25o C to -10o C
  • Refrigerated 2o C to 8o C
  • 25o C with 60% Relative Humidity (RH)
  • 30o C with 60% RH
  • 40o C with 75% RH

(Please inquire about customized temperature and humidity storage conditions.)

For our instrumental capabilities please click here.


  Analytical Bioanalytical Chemistry Consulting Stability Formulations  
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