Method Development and Validation

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.

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.

Stability Studies for sterile products commonly include:

  • A stability-indicating potency assay method
  • Sterility
  • Endotoxin
  • pH
  • 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.



Container Closure Testing

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: 

  1. Entry of microorganisms
  2. Escape of the product dosage form or entry of liquids or solids
  3. Escape of nitrogen gas or entry of oxygen, water vapor, or air gase