| 摘要: |
| 阐述了首批苯甲磺酰截短侧耳素国家对照品的研制过程。苯甲磺酰截短侧耳素对照品为白色或类白色粉末,红外光吸收图谱与USP溯源对照品图谱一致,质谱法测定分子离子峰为555.19 Da([M+Na]+),高效液相色谱法测定其平均纯度为99.7%,可作为系统适用性对照品,用于延胡索酸泰妙菌素及其制剂含量测定的系统使用性检查。 |
| 关键词: 苯甲磺酰截短侧耳素 国家对照品 鉴别 纯度 |
| DOI： |
| 投稿时间：2018-12-20修订日期：2019-01-29 |
| 基金项目: |
|
| Development of Tosyl Pleuromutilin as National Reference |
|
| (China Institute of Veterinary Drug Control) |
| Abstract: |
| The method of developing Tosyl Pleuromutilin as national reference was introduced. The Tosyl Pleuromutilin national reference was white to almost white powder. The IR spectrum was consistent with the USP traceable reference. The molecular ion peak was 555.19 Da ([M+Na]+) by MS. The average purity was 99.7% by HPLC. It can be used as a reference for the test of system applicability during the content determination of Tiamulin Fumarate and its related preparation. |
| Key words: Tosyl Pleuromutilin National Reference Identification Purity |
