| 奥扎格雷钠氯化钠注射液中特定杂质的研究 |
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| 引用本文： | 于明,张迪,李沫,孙宽. 奥扎格雷钠氯化钠注射液中特定杂质的研究[J]. 中国药师, 2012, 0(10): 1421-1423 |
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| 作者姓名： | 于明 张迪 李沫 孙宽 |
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| 作者单位： | 辽宁省食品药品检验所 |
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| 摘 要： | 目的：研究奥扎格雷钠氯化钠注射液中的特定杂质。方法：采用HPLC/MS和HPLC法对奥扎格雷钠氯化钠注射液中的特定杂质进行研究,并对44批样品进行测定。结果：初步确定了两个特定杂质的结构,44批样品中杂质Ⅰ的含量为0.06%～0.24%,杂质Ⅱ的含量为0～0.26%。结论：奥扎格雷钠氯化钠注射液中杂质Ⅰ与原料药的合成工艺有关,杂质Ⅱ为制剂中奥扎格雷钠的降解产物。
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| 关 键 词： | HPLC MS 奥扎格雷钠氯化钠注射液 杂质 |
| 收稿时间： | 2012-04-27 |
| 修稿时间： | 2012-07-10 |
Study on the Specific Impurities in Ozagrel Sodium and Sodium Chloride Injections |
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| Yu Ming,Zhang Di,Li Mo and Sun Kuan. Study on the Specific Impurities in Ozagrel Sodium and Sodium Chloride Injections[J]. China Pharmacist, 2012, 0(10): 1421-1423 |
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| Authors: | Yu Ming Zhang Di Li Mo Sun Kuan |
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| Affiliation: | (Liaoning Institute for Food and Drug Control,Shenyang 110023,China) |
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| Abstract: | Objective: To study the specific impurities in ozagrel sodium and sodium chloride injections.Method: Two specific impurities in 44 batches of ozagrel sodium and sodium chloride injections were determined by HPLC/MS and HPLC.Result: The structures of the two specific impurities were inferred.In the tested ozagrel sodium and sodium chloride injections,the content of impurityⅠand Ⅱwas 0.06%-0.24% and 0-0.26%,respectively.Conclusion: ImpurityⅠis related with the synthesis route of ozagrel.ImpurityⅡis the degradation product produced in the preparation process of the injections. |
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| Keywords: | HPLC/MS Ozagrel sodium and sodium chloride injections Impurity |
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