Does the method used in the HSQ Kit for HPLC need to be validated – FAQ

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ARTICLES, APPNOTES, FAQ (9187)
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February 17, 2017
Bill Ciccone

ARTICLES, APPNOTES, FAQ / Equipment FAQ / Frequently Asked Questions?? / General Information / HPLC Qualification / HPLC Suggestions and Information / HPLC Tips and Suggestions / Qualification FAQ / Qualification Information / Qualification Tech Information

Validation of the method would not be applicable since it is used to qualify the instrument itself.

Suppose you’re talking about LOD or LOQ of the HPLC method as a validation parameter, for example. You wouldn’t need to validate this parameter in the HSQ Kit™ method because its calculation first assumes that the detector is responding in an accurate manner; however, detector accuracy is one of the parameters that the HSQ Kit™ itself qualifies. Validation of this HPLC method is not required by any federal regulation.

Please note that before you validate a method, you must complete IQOQPQ on the instrument.

Click HERE for PQ & HSQ Kits™ ordering information and pictures.

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