Stability Storage and Testing Services

Millennium Research Laboratories, Inc.

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. The highlights of our Stability Program are as follows:

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

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 additional temperature and humidity conditions which are available if required.) To know more about our other services please click on any of the following links: