High Resolution Mass Spectrometer

Forecast overview

Subagency

FDA

NAICS

334516

Program office

CDER ACQUISITION

LC-HRMS system with high sensitivity to support the needs of genotoxic impurty testing of human medicines and high resolution and high sensitifity needed for impurity profiling of complex drugs (e.g., peptide and protein drug products). The instrument supports the agency mission by providing data needed to assess complex drug products that are an increasing share of the US drug supply. These work-horse instruments have the capability for high throughput analysis. Software is used for the analysis of MS data for the characterization of biopharmaceuticals and the update includes a package for processing oligonucleotide data will imrove agency lab capability to provide needed information on the quality of these complex drugs. The instrument will primarily support GDUFA and OMUFA user fee program needs.

Source

Source

HHS SBCX Forecast Export

Source file

Forecast.csv

Official source

Agency forecast source

Last verified

2026-08-31

Agency-published contact: · TBD@fda.hhs.gov

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