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Low Endotoxin Hold-Time Study Considerations

lab technician conducting a low endotoxin recovery hold-time study

Although there is no data to support the claims that Low Endotoxin Recovery (LER) is, or ever has been, a patient safety risk, your organization may choose to perform LER hold-time studies.

These studies help determine whether a product has LER within certain hold-time conditions, which would indicate the likelihood of any potential effects the sample or product matrix may have on endotoxin in drug products during the manufacturing process.

This white paper describes LER hold-time study methods and contains recommendations for performing LER hold-time studies.

Download the White Paper