International Journal of Analytical Chemistry / 2009 / Article / Tab 5

Research Article

A Multidisciplinary Investigation to Determine the Structure and Source of Dimeric Impurities in AMG 517 Drug Substance

Table 5

Mass error analysis of the observed accurate mass for fragments generated by the acid hydrolysis of the enriched impurity fraction. The analysis is conducted for both the thioether and bis-sulfoxide structures proposed for Unknown 2. (ND: not detected; N/A: not applicable.)

Obs. mass (M + H)+ (Da) Calc. mass thioether (M + H)+ (Da) Calc. mass bis-sulfoxide (M + H)+ (Da) Mass error thioether (ppm) Mass error bis- sulfoxide (ppm)

Unknown 2 891.1081891.1060891.12372.417.5
U2-669 669.0674669.0655669.08322.823.6
Mono-deacetyl627.0552 627.0549627.07270.5 27.9
U2-447 447.0250447.0250447.04280.039.8
Mono-deacetyl405.0158 405.0144405.03223.5 40.5
241 241.0579241.0583241.05831.71.7

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