Qualification of LC-UV and LC-MS Peptide Mapping Systems

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Paul Rainville;Himanshu Gadgil;Da Ren;Reb Russell;Jeff Mazzeo [Waters]
WCBP, January 6-9 Washington D.C.
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MassPREP™ Peptide Standard Mix; Allantoin; RASG-1; Angiotensin Fragment 1-7; Bradykinin; Angiotensin II; Angiotensin I; Renin Substrate; Enolase T35; Enolase T37; Melittin
BioSuite C18 PA-A 3 µm Peptide Analysis Column 2.1 mm 250 mm
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Peptide mapping is one of many techniques used in the characterization of protein based pharmaceuticals. Data acquired from peptide mapping analysis is often used for determining identity, stability, lot release and for the evaluation of manufacturing process changes. Peptide mapping combined with mass spectrometry directly identifies modifications or structural variants that may occur during manufacturing or during storage. These modifications include oxidation, deamidation and proteolytic degradation products. Peptide mapping is an indispensable tool in protein characterization; therefore it is desirable to develop installation, operation, and performance qualification tests for HPLC systems using UV and MS detection. Here we show a study of parameters that were evaluated in developing qualification tests for dedicated peptide mapping systems. Parameters that were examined included reproducibility of retention time, area counts, signal to noise ratios, and mass accuracy.

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