LAL BACTERIAL ENDOTOXINS TESTS – USP OR EP

LAL Bacterial Endotoxins Tests – USP or EP

Kinetic Turbidimetric or Chromogenic Methods

• Water
• Liquids
• Powders
• Concurrent Assay of Sample Dilution
• Non-concurrent Assay of Sample Dilution

LAL tests using the gel clot method

LAL Validation – Method Verification and Validation
This testing is performed on products and materials for which a specific kinetic LAL test method has not yet been established. It generally involves testing additional dilutions of the product to address any inhibition or enhancement issues. The validation testing also serves as product release testing for the lot(s) tested. For some products, additional method development may be required and additional fees would apply.

Kinetic Turbidimetric or Chromogenic Methods

• LAL Validation (one lot)
• LAL Validation (three lots, concurrently tested)