How to Ensure WFI, Raw Materials and Finished Product are Pyrogen Free
All Pharmacopoeias and regulatory bodies outline the submission and maintenance of pyrogen and endotoxin analysis for regulated pharmaceutical products.
- We are experts in the validation of endotoxin recovery after developing methods for an array of product presentations and formulations.
- Following validation, we are able to perform routine Endotoxin analysis via the Limulus Amebocyte Lysate (LAL) turbidometric kinetic assay method.
- Validation is essential as certain products can interfere with the LAL assay via enhancement or inhibition.
- We routinely perform LAL assays on client Water-for-Injection in accordance with the pharmacopoeial specification of <0.25EU/ml.
- We can detect as low as 0.001 EU/ml.
Date Published: 18th February 2019
Source article link: Honeyman Group Ltd
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