No, validation of the Chemical Solutions HPLC Qualification Kits™ method is not required. This method is specifically designed to qualify the performance of the HPLC instrument itself.
For example, if you're considering validation parameters like LOD (Limit of Detection) or LOQ (Limit of Quantitation), these are not applicable in this context. The HPLC Qualification Kits™ assumes the detector is functioning correctly—but verifying that assumption is exactly what the kit is designed to do. In other words, the method relies on the detector’s performance, which the kit is actively qualifying.
Additionally, there is no federal regulatory requirement mandating validation of this method, since it is not intended for product testing or regulatory submission.
🔍 Important Note: Before performing any method validation on your HPLC system, you must first complete IQ/OQ/PQ (Installation, Operational, and Performance Qualification) to ensure the instrument is functioning within specifications.
📦 Click HERE for PQ & HSQ Kit™ ordering information and product images.