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:

Refrigerated/Frozen Conditions

• Freezer -25^o C to -10^o C
• Refrigerated 2^o C to 8^o C

ICH Conditions

• 25^o C with 60% Relative Humidity (RH)
• 30^o C with 60% RH
• 40^o C with 75% RH

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

For our instrumental capabilities please click here.