Nitrosamines Impurities Analytical Methods Repository
It is a public online repository containing non-compendial analytical procedures (analytical notes) for the testing of nitrosamine impurities and related substances.
USP’s scientists curate these analytical procedures through internal development/validation or through scientific review of non-compendial donations.
They are NOT compendial standards. The procedures in the analytical notes
should be validated by the user. USP is not and will not be responsible for use or implementation of the procedures. Hosted in The Nitrosamine Exchange. The Analytical Hub allows keyword searches and the view of key analytical procedure parameters and chromatograms.
The analytical notes can also be downloaded in PDF format solely for internal use and it contains all the information needed to run, process and report the analysis described in the note.
Are the Technotes from LCMS and other technologies vendors accepted?
@Frabaneda we are looking at the potential donation of method for the analytical Hub. You can message me with potential ideas or suggestions for methods to include. We will certainly need additional validation data to build the application note. You can use the current note as reference.
This analytical note highlights a robust and sensitive procedure for the quantification of six nitrosamine impurities NDMA, NDEA, NDIPA, NEIPA, NDPA and NDBA in common (commercial and analytical) solvents used during pharmaceuticals manufacturing at trace levels by GC-MS/MS. The procedure was validated according to USP General Chapters <1225> and <736>
LOQ of 0.005 ppm for NDMA, NDEA, NEIPA, NDIPA,
NDPA in analytical-grade solvents with respect to 100
mg/mL sample concentration.
LOQ of 0.013…
can you please send me your email and I will send the different methods?
My email address: