Pharmaceutical Testing: Method Development & Validation:

Since our inception in 1987 we have validated over seven-hundred analytical procedures. Literally hundreds of stability indicating HPLC & GC procedures have been validated. Through our experience and by working closely with the client we are able to streamline the development process to reduce cost. We have experience working with all types of product formulation and offer the Plackett-Burmam design for Robustness Studies.

Methods are developed and validated according to either a specific client protocol or Boston Analytical's own Standard Operating Procedure. Methods are validated in compliance with FDA and ICH guidelines. All validation projects can be custom designed to meet your specific analytical requirements.

A validation report is provided with every method. Methods are written in an easy to understand, step-by-step format to simplify method transfer.

Method 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