The U.S. Food and Drug Administration (FDA), Office of Testing and Research (OTR), Division of Pharmaceutical Analysis (DPA) requires a new UHPLC (Ultra High-Performance Liquid Chromatography) instrument with a Diode Array Detector (DAD) to replace the current HPLC connected to the Thermo-Scientific Orbitrap QExactive™ mass spectrometer.  The current HPLC, the Thermo-Scientific Accela HPLC, is obsolete and is no longer supported by the manufacturer.  The replacement UHPLC should be compatible with the current Xcalibur operating software and QExactive™ mass spectrometer.  This instrument shall be brand name or equal to Thermo-Scientific Vanquish Flex UHPLC System. The UHPLC should therefore be ready to use and fully compatible with the existing MS system software and hardware right out of the box.  This will prevent any problems with the functionality of the replacement UHPLC within the Thermo-Scientific QExactive™ mass spectrometer system. 

The Thermo-Scientific QExactive™ mass spectrometer system is mainly used to support testing and research work related to or in support of the Method Verification Program (MVP), Advance Manufacturing and Analysis of Nitrosamine contaminated drugs.

Amendment 01: 

Description:

The purpose of this Amendment 01 is to do the following:

1. To provide final responses to the questions received for the RFQ as part of the amendment.

All other terms and conditions outlined in the RFQ remain unchanged.  No further questions will be answered.