ARL Bio Pharma has extensive experience in analytical method development/validation for a variety of drug substances and products.
Our laboratory validates analytical methods based on ICH, USP, FDA and industry best-practice guidelines. Validation parameters are based on USP <1225> Validation of Compendial Procedures, including: Accuracy, Linearity, Precision, Range, Specificity, and System Suitability. Additional validation characteristics are available. Forced degradation/ stress studies are utilized for the development and validation of stability-indicating methods for incorporation into a stability study program.
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.
Stability Studies for sterile products commonly include:
- A stability-indicating potency assay method
- Visual inspection
- Particulate matter
- Preservative effectiveness
- Preservative quantification
- Container Closure Testing
Non-sterile product stability studies replace sterility and endotoxin testing with Bioburden/ microbial limits testing and dosage form dependent tests for the Absence of specified organisms.
- 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
- Importance of Forced Degradation in Stability Indicating Methods
- Palonosetron Hydrochloride Compatibility and Stability with Three Beta-Lactam Antibiotics During Simulated Y-Site Administration
- 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
- What Factors Influence Stability?
The container closure system for a drug product provides critical protection for stability and sterility. ARL offers USP <1207> container closure integrity testing (CCIT) on IV bags, syringes, cassettes, and vials. Three types of leaks that can be detected during CCIT include:
- Entry of microorganisms
- Escape of the product dosage form or entry of liquids or solids
- Escape of nitrogen gas or entry of oxygen, water vapor, or air gase