Stability Programs

BSM Stability Services:

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

Stability & Release Testing:

BSM prides itself on customer service and flexibility while keeping the integrity of your data at the highest level. We work with your analytical team to develop stability protocols that are specific to the needs of your study and will give you the most effective measure of your drug’s stability. We design these with set pull points, the temperature of incubation, and testing protocol for each pull point.  A final report will be provided at the end of each study time-frame but you will receive interim reports throughout the stability study with a review and sign off from our quality department. Our validated chambers we have available for storage are listed below, but if you need an additional temperature point, then BSM will purchase, install, map, and validate the new chamber on request. 

BSM has the latest technology in environmental stability and photostability chambers. These are monitored remotely 24/7, and they are placed on generators with an alarm based system to protect the integrity of your drug program. 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.

What We Offer:

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

Available Stability Chambers:

  • -80°C
  • -20°C
  • 2-8°C
  • 25°C ± 2°C (60% RH ± 5% RH)
  • 40°C ± 2°C (75% RH ± 5% RH)