Stability

Our scientists have years of experience in performing stability testing for all types of commercial and premarket drug products, from placebos to controlled drugs. We offer standard storage conditions, meeting ICH guidelines, along with any specialized storage conditions your product may require.

Analytical services:

  • Protocol Design
  • Long-Term Stability Testing
  • Accelerated Stability Testing
  • Drug Substance Stability Testing
  • IND, NDA, ANDA Stability Testing
  • Commercial Product Stability Testing
  • Comparator Stability Testing
  • Formulation Evaluation Stability Testing
  • Statistical Analysis and Data Trending
  • Forced Degradation Studies
  • Photostability
  • Temperature Cycling

Storage:

  • Catalent Pharma Solutions offers approximately 22,000 cubic feet of storage area over a broad range of storage conditions.
  • Facility in Research Triangle Park, NC* has 37 chambers, which includes 16 walk-in chambers.
  • Facility in Somerset, NJ* has 19 chambers, which includes 4 walk-in chambers.
  • Facility in San Diego, CA* has 17 chambers, which includes 4 walk-in chambers.

Each stability chamber operates independently with its own temperature and, where applicable, humidity controls. All storage chambers are continuously monitored by a computerized Kaye Monitoring System and a hardwired security system. Temperature and humidity setpoint windows are 2 degrees C and 5% RH, respectively, and failures outside setpoint ranges result in an immediate alert to the stability staff.

Additionally, all of our storage chambers are on full generator backup in case of power failure. Backup power is fully operational within 6 seconds of power failure.

Photostability:

  • Light Exposure/Temp. Control:
  • ICH Option 1 and 2 with Temperature Control and Monitoring at 25° C
  • Fluorescence 200-1000 foot candle
  • Room Light/CRT

Chamber qualifications:

  • Kaye Instrument Stability Monitoring System (Out of range alarms and notification)
  • Full Generator Backup
  • Hardwired Security System
  • Backup Water System

Types of sample storage

  • Drug Product
  • Drug Substance
  • Raw Material
  • Placebo/Excipients
  • Comparator Drug Product
  • Controlled Drugs
*DEA Licensed Facilities for Controlled Drugs Schedules I-V

For capabilities that meet your needs, and outcomes that exceed your expectations, partner with Catalent today. For more information fill out our Contact us form or call a member of our sales staff toll-free at 866.720.3148.