• Stability Storage
  
  
• Thermal Cycling
  Stability Testing
  
  
• Photostability Testing & Photodegradation Studies
  
  
• Clinical Registration &
  Annual Stability Studies
  
  
• Blind Comparator
  Stability Studies
  
  
• Formulation Development
  & Optimization


• Method Development
  and Validation
  
  
• USP Testing
  
  
• In-process and Lot
  Release Testing
  
  
• Raw Material Testing

Boston Analytical has the depth and breadth of expertise you are looking for when you need new method development and validation, or when you are seeking to refine and streamline existing methods to meet specific requirements and reduce cost.

Method validation projects can be custom-designed to meet your specific analytical requirements, or you can choose to have the methods developed according to Boston Analytical's proven Standard Operating Procedures. We also offer the Plackett-Burmam Design for Robustness Studies. All methods are validated in compliance with FDA and ICH guidelines.

Method Development and Validation Parameters: Stability Indicating Forced Degradation Studies Specificity Method Precision Sample Precision Linearity and Range Accuracy LOD/LOQ Ruggedness Standard Solution Stability Sample Solution Stability Robustness

Accurate, Precise, Reproducible Methods
At Boston Analytical, we believe that methods need to be user-friendly while at the same time meeting the standards for robustness and ruggedness. That is why we provide you with a written method development and validation report with every method. Methods are written in an easy-to-understand, step-by-step format to simplify method transfer.