Methods Development and Validation Services

Description

We provide specialized method development and validation services for bacterial endotoxin testing to ensure your products meet global pharmacopeial standards (IP, USP, EP, BP, JP).

Our Services Include

Method Selection: Gel Clot, Kinetic Turbidimetric, or Kinetic Chromogenic based on product type.
Method Development: Optimizing test conditions for accurate endotoxin detection.
Method Validation: Performing interference studies, suitability testing, and validation according to regulatory guidelines.
Documentation: Complete validation reports to support GMP compliance and regulatory audits.