| 加米霉素对照品标定方法的建立 |
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| 引用本文： | 张聪,姚路路,侯林,樊丽博,杨会鲜,周德刚,张晓会.加米霉素对照品标定方法的建立[J].中国兽药杂志,2019,53(3):67-71. |
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| 作者姓名： | 张聪 姚路路 侯林 樊丽博 杨会鲜 周德刚 张晓会 |
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| 作者单位： | 国家兽用药品工程技术研究中心,,,,,,洛阳惠中兽药有限公司 |
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| 摘 要： | 建立了加米霉素对照品的标定方法。采用紫外光谱、红外光谱、核磁共振波谱、质谱和X射线单晶衍射进行结构确认,高效液相色谱法进行纯度检查,质量平衡法进行定量分析,并采用定量核磁技术对赋值结果进行验证。结果显示,加米霉素对照品原料纯度为99.9%;质量平衡法赋值结果为98.8%,定量核磁共振法验证结果为98.3%。加米霉素对照品原料定量赋值结果准确、可靠,能够用于加米霉素原料及制剂的鉴别和含量测定。
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| 关 键 词： | 加米霉素 对照品标定 结构确证 质量平衡法 定量核磁共振 |
| 收稿时间： | 2018/12/10 0:00:00 |
| 修稿时间： | 2019/3/5 0:00:00 |
Establishment of Chemical Reference Substance of Gamithromycin |
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| Institution: | National Research Center for Veterinary Medicine,,,,,, |
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| Abstract: | To establish Chemical Reference Substance of Gamithromycin.The structure of the candidate material was characterized by ultraviolet-visible(UV), infrared(IR), nuclear magneticresonance(NMR), mass spectrum and x-ray single crystal diffraction. Its chromatographic purity was determined by HPLC. The results of qualitative identification of Gamithromycin was 99.9%. The assigned value by mass balance method was98.8%, in accordance with that obtained by quantitative NMR(98.3%. The structure and purity of the Gamithromycin material met the requirements of CRS for assay. The accuracy of the assigned value obtained by mass |
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| Keywords: | Gamithromycin substance calibration structural characterization standard material analysis mass balance method |
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