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

Table 1

Gradient conditions used for the HPLC-UV and LC-MS analyses of AMG 517 and N-acetyl benzothiazole.

Compound	AMG 517		N-acetyl Benzothiazole
	(HPLC-UV and LC-MS)		(HPLC-UV)		(LC-MS)
Gradient program	Time (min)	%B	Time (min)	%B	Time (min)	%B
	0	5	0	5	0	5
	15	65	10	30	10	30
	20	70	15	50	15	50
	27	98	20	75	20	75
	30	98			25	95
Flow rate	1.0 mL/min		1.5 mL/min		1.0 mL/min
Sample diluent	50% ACN/50% water		10% ACN/90% water