LAL Preliminary Assay

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When using the LAL Gel Clot method, the quantitative LAL assay is usually used on liquid products in which a Preliminary Assay and a Validation of a dilution series is performed. Although not common, the quantitative assay can be performed on devices. The Preliminary Assay tests for the pH of the product. The pH must be compatible with the LAL gel clot assay in order for a validation to be performed. This Validation tests the product dilution series for an endpoint which is used to calculate the final range of endotoxin concentration present in the product.