Analytical Method Transfer

Authored by: Michael E. Swartz , Ira S. Krull

Handbook of Analytical Validation

Print publication date:  April  2012
Online publication date:  April  2012

Print ISBN: 9780824706890
eBook ISBN: 9781420014488
Adobe ISBN:

10.1201/b12039-9

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Abstract

The objective of a formal method transfer is to ensure that the receiving laboratory is well trained, qualified to run the method in question, and gets the same results— within experimental error—as the initiating laboratory. The development and validation of robust methods and strict adherence to well-documented standard operating procedures (SOPs) is the best way to ensure the ultimate success of the method. This chapter examines the analytical method transfer process, including protocol, documentation, and some possible chromatographic pitfalls to avoid.

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