Research Article
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 |
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