| 发明名称 |
METHODS FOR ANALYSIS OF PROTAMINE |
| 摘要 |
The invention provides a method for analyzing a protamine sample for the presence or amount of at least one nucleotidic impurity. The invention also provides a method for the quantitation of peptides in a sample of protamine comprising four major peptides and at least one related impurity. |
| 申请公布号 |
US2015104785(A1) |
申请公布日期 |
2015.04.16 |
| 申请号 |
US201314055625 |
申请日期 |
2013.10.16 |
| 申请人 |
Fresenius Kabi USA, LLC |
发明人 |
MOWLI Jay;TORRALBA Pearle;JESCHKE David;PATEL Kamlesh |
| 分类号 |
G01N33/68 |
主分类号 |
G01N33/68 |
| 代理机构 |
|
代理人 |
|
| 主权项 |
1. A method for analyzing a protamine sample for the presence or amount of at least one nucleotidic impurity, comprising the steps of:
(a) providing a protamine sample, (b) subjecting the sample of protamine to disruption with a protamine-disrupting agent to provide a first mixture, (c) subjecting the first mixture to a digestion step to provide a second mixture, and (d) determining the presence or amount of the at least one nucleotidic impurity present in the second mixture. |
| 地址 |
Lake Zurich IL US |
