BSM provides the following stability services:

  • Clinical trials
  • Commercial
  • NDA
  • BLA
  • ANDA
  • IND

Stability and Release Testing:

BSM will work with your analytical team to develop stability protocols that are specific to the needs of your study. We design these with set pull points, temperature of incubation, list of testing for each pull point, and provide interim reports at each testing point.  We work closely with the client and our quality department to ensure that your study is designed to give you the most effective measure of your drugs stability.   A final report will be provided at the end of each study time-frame but the client will receive interim reports throughout the stability study with a review and sign off from our quality department.  Below we list the validated chambers that BSM currently has available to clients for storage.  If a client needs an additional temperature point that is not included below BSM is open to purchasing installing, mapping, and validating the new chamber.  We pride ourselves on customer service and flexibility while keeping the integrity of your data at the highest level.

BSM has the latest in environmental stability and photostability chambers. These are monitored 24/7 remotely and placed on generators with an alarm based system to ensure your drug program integrity. BSM provides -80°C, -20°C, 2-8°C, 25°C ± 2°C (60% RH ± 5% RH), 40°C ± 2°C (75% RH ± 5% RH) chambers for your product stability assessment.

Stability Services

  • Protocol generation
  • Testing
  • Storage
  • Interim Reports
  • Summary report generation
  • Preclinical – Clinical stability