Stability Studies
A stability study measures the extent to which a product retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding.
A study commonly includes: a stability indicating method assay, sterility (for sterile preparations), endotoxin (for most sterile preparations), pH, visual inspection, particulate matter, preservative effectiveness, preservative quantification, microbial limits (for non-sterile preparations), and the absence of specified organisms (for non-sterile preparations).
Articles:
- Chemical Stability of Admixtures Containing Ziconotide 25 mcg-mL and Morphine Sulfate 10 mg-mL or 20 mg-mL During Simulated Intrathecal Administration
- Compatibility and Stability of Palonosetron Hydrochloride and Propofol During Simulated Y-Site Administration
- Compatibility and Stability of Palonosetron Hydrochloride with Four Neuromuscular Blocking Agents During Simulated Y-Site Administration
- Compatibility and Stability of Palonosetron Hydrochloride with Gentamicin Metronidazole or Vancomycin During Simulated Y-Site Administration
- Compatibility of Caspofungin Acetate Injection with Other Drugs During Simulated Y-Site Coadministration
- Compatibility of Micafungin Injection with Other Drugs During Simulated YSite Coadministration
- Drug Compatibility with a New Generation of VISIV Polyolefin Infustion Solution Containers
- Extending Beyond Use Date for Compounded Preparations
- Importance of Forced Degradation in Stability Indicating Methods
- Palonosetron Hydrochloride Compatibility and Stability with Three Beta-Lactam Antibiotics During Simulated Y-Site Administration
- Pharmaceutical Compounding Errors
- Physical and Chemical Stability of Palonosetron Hydrochloride with Glycopyrrolate and Neostigmine During Simulated Y-Site Administration
- Physical and Chemical Stability of Palonosetron with Metoclopramide and Promethazine During Simulated Y-Site Administration
- Proactive Approaches to Mitigate Stability Failures
- Quality Control Analytical Methods-Stability Versus Potency Testing-The Madness is in the Method
- Stability of Metronidazole Benzoate in SyrSpend SF One-Step Suspension System
- Stability vs. Potency Testing
- What Factors Influence Stability?
Webinars:
- Beyond Use Date Strategies for Compounded Preparations
- Compounded Sterile Products: Extending Beyond Use Dating and Batch Release Testing for 503A and 503B Facilities
- Extending Beyond Use Dating for Compounded Preparations
- Root Causes of Stability Failures
- Stability Indicating Methods
- Stability Studies: Architecture Behind Establishing a Beyond Use Date
- Stability Testing: Science and Compliance