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双语推荐：杂质谱

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目的：对氯氮平及其制剂的有关物质进行分析研究。方法：采用《中国药典》及《美国药典》（USP）的方法进行对比分析。结果：国产原料与进口原料杂质谱基本一致,制剂杂质谱与原料杂质谱基本一致,USP所用方法对杂质的分离优于《中国药典》所用方法。结论：《中国药典》现行法定检验标准检验有待研究提高。
Objective: To study the related substances in clozapine and its preparations. Methods:Comparative analysis was adopted according to the method respectively described in Chinese pharmacopoeia and United States pharmacopoeia. Results:The impurity profile of clozapine from domestic and abroad was basically the same, and that of clozapine and its preparations was also basically the same. The method in United States pharmacopoeia was better than that in Chinese pharmacopoeia in terms of in terms of separation of the impurities. Conclusion: The current legal inspection standard for the related substances in clozapine described in Chinese pharmacopoeia should be improved.

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采用场发射扫描电镜和能谱仪对杂质含量高、硬度大的边皮海绵钛颗粒和普通海绵钛颗粒表面及内部杂质的分布进行了研究。研究发现，海绵钛中的杂质不仅具有钛坨中心部位杂质含量低周边杂质含量较高的宏观分布规律，而且具有杂质成团聚集在海绵钛颗粒表面的微观结构特征。采用化学溶解法可以显著降低海绵钛的杂质含量和布氏硬度。
The distribution of impurities in the inner and the outside of titanium sponge particles was studied with field emission scanning electron microscopy(FESEM) and energy dispersive spectrometer(EDS).The results show that not only impurities content in the central part of the whole titanium sponge is lower than that in the circular edged titanium sponge but also the impurities agglomerating on the surface of titanium sponge particles .The impurities agglomerating on the surface can be easily dissolved by dilute hydrochloric acid , which will make impurities content and Brinell hard-ness(HB)of the titanium sponge decreased obviously .

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通过蒸发捕集法与溶液吸收法两种前处理方法,利用高分辨电感耦合等离子体质谱对高纯氨中痕量金属杂质进行上机检测.实验表明,双聚焦磁质谱对稀氨水中金属杂质方法检出限低达10-12 级,对高纯氨中金属杂质方法检测限低于1×10^-9 m/m.方法便捷、准确,容易避免前处理污染,可以作为高纯氨中金属杂质检测的有效手段.
By means of evaporation capture method and solution absorption method, the project take advantage of high resolution ICP-MS to detect metal impurities in high purity ammonia. Experimental results show that LOD of most metallic element in diluted ammonia water will achieve 10-12 level by means of sector field spectrometer, accordingly it can be as low as 1×10-9 m/m in high purity ammonia. The method is convenient, accurate and easy to avoid the pollution caused by pretreatment, therefore it can be used for detecting metal impurities in high purity ammonia.

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左氧氟羧酸是合成喹诺酮类抗菌药物左氧氟沙星的主要原料,在其合成过程中产生了一个微量未知杂质。运用高效液相色谱/质谱联用结合串联质谱技术对其进行分析发现,该杂质的分子量及分子式与左氧氟羧酸的相同,其碰撞诱导解离二级和三级质谱产生的碎片离子及其丰度也与左氧氟羧酸的相似。通过对该杂质的多级质谱裂解机理进行分析总结,结合高分辨质谱数据,推测该杂质为9,10-二氟-11-羟基-2-甲基-2,3-二氢-1,6-苯并[e][1,4]噁唑啉-5,7-二酮,与左氧氟羧酸分子结构的差异体现为异丙基环合位置不同。其结构得到核磁共振波谱技术的进一步确证。
An unknown impurity in the bulk drug levofloxacin carboxylic acid was detected by high perfor-mance liquid chromatography coupled with mass spectrometry (HPLC-MS). The impurity has the same formula and molecular weight with levofloxacin carboxylic acid. The mass multi-stage spectrometric spectra (MSn) of impurity exhibit characteristic fragmentation routes similar to those of levofloxacin carboxylic acid. The un-known product was then proposed as 9, 10-difluoro-11-hydroxy-2-methyl-2, 3-dihydro-1, 6-(metheno)benzo[e][1, 4]oxazonine-5, 7-dione on the basis of the proposed mass spectrometric mechanism and exact mass evidences. The proposed structures were further confirmed by NMR experiments.

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目的通过对抽验结果数据进行统计分析,评价国产硫酸庆大霉素注射液的质量现状。方法依据现行法定质量标准,对全国范围内的硫酸庆大霉素注射液进行法定标准检验,运用多种统计学方法,分析国内硫酸庆大霉素注射液的质量总体水平,比较不同生产企业产品质量;根据专题调研、文献检索和检验结果及分析等情况,开展了杂质谱、组分纯度和离子色谱法测定有关物质等探索性研究,探讨了有关物质、组分纯度和效价的关系。结果本次抽验中涉及的318批次样品标准检验,其中,2批溶液的颜色超标,8批有关物质不符合规定,1批含量不符合规定。杂质谱研究结果显示,各企业杂质谱基本固定,原料和对应制剂杂质个数和杂质含量均一致;解决了用高效液相色谱法测定庆大霉素组分纯度的问题。结论目前绝大部分国产硫酸庆大霉素注射液生产工艺成熟,质量状况较好;杂质谱研究有助于产品的质量控制,进而促进产品质量的提高;新建组分纯度测定方法可更直观地反映产品的质量状况。
Objective To evaluate the quality condition of sulfate gentamicin injection at present, through the statistical analysis of the results of sampling inspection data.Methods According to the current quality standard, the nationwide sulfate gentamicin injection examination was conducted. Multiple statistical methods were used to analyze the overall quality of the domestic sulfate gentamicin injection and the product quality of different manufacturing enterprises was compared.Based on the results of special investigation,literature search and analysis of testing results,exploratory study was carried out covering impurity profiling,component purity and determination of related substances with ion chromatography. The relationship among related substances,component purity and potency was discussed.Results According to the current standard,among the 318 batches of samples tested,2 batches failed because of solution colour,8 batches failed because of impurity and 1 batch failed becaus

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目的：：建立注射用兰索拉唑有关物质测定方法,并对其杂质进行定性研究。方法：采用液相色谱及液相色谱-质谱联用技术,DAD检测器检测,等度洗脱方式。结果：样品中检出的单个杂质为杂质B。结论：该方法简便、快速、灵敏度高,可用于注射用兰索拉唑有关物质的检测。
Objective:To establish the method for determining the related substances in lansoprazole for injection and qualitatively study the impurities. Methods:An HPLC method and an HPLC-MS method were used with isocratic elution and DAD as the detector. Results:The priciple impurity in all samples was impurity B. Conclusion:The method is fast, simple and sensitive, and suitable for the determination of the related substances in lansoprazole for injection.

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在对我公司生产的柳氮磺胺吡啶原料药进行杂质研究时，分离提纯到一个未知杂质，并根据质谱（MS）和核磁共振（NMR）数据确定了其结构为双{4-[（2-亚氨基吡啶-1（2H）-基）磺酰]苯基}胺。
An unknown impuritiy in active pharmaceutical ingredients (API) of Sulfasalazine produced by our company was isolated and its structure was elucidated as bis{4-[(2-iminopyridin-1(2H)-yl)sulfonyl]phenyl}amine based on the data of MS and NMR.

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为确定购买的金刚烷胺标准品中使纯度受限的主要杂质成分，用质量平衡法对标准品中主成分含量进行定值分析。采用红外光谱、质谱等方法对金刚烷胺标准品的主成分进行定性，用气相色谱–质谱法、顶空气相色谱法、卡尔费休法对其主要杂质进行确证并定量。结果表明金刚烷胺标准品中主要杂质成分为溴代金刚烷胺、甲醇、乙苯和水，含量分别为1.53%，0.0376%，0.0045%，0.41%，经计算金刚烷胺标准品的纯度为98.16%。该方法可用于金刚烷胺标准品主要杂质的定性、定量分析，对其纯度值进行验证。
To determine the related substances which limit the purity of the amantadine standard and the mass balance method was adopted to definite the value of component content of amantadine standard. Infrared spectrum and mass spectrum method were adopted to determine the nature of the main component of amantadine standard. At the same time,the gas chromatography–mass spectrometry,headspace gas chromatography and Karl Fischer method were applied to identify and quantify the related substances. Ultimately,1-bromoadamantane,methanol,ethylbenzene and water were the main impurities in amantadine standard,and the content of which were 1.53%,0.037 6%, 0.004 5%and 0.41%. The purity of the amantadine standard was 98.16%. This method can be used for qualitative and quantitative analysis of main impurities in amantadine,and verification of amantadine purity.

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通过测定间二氯苯中的杂质含量得到间二氯苯的纯度。分别采用高效液相色谱法(HPLC–UVD)和气相色谱法(GC–FID)测定间二氯苯中主要杂质邻、对二氯苯的含量,结果表明两种方法所得杂质含量一致;用高效液相色谱法(HPLC)测定间二氯苯中杂质苯的含量,卡尔费休(Karl Fischer)法测定水分含量,热重法(TGA)进行灰分测定,电感耦合等离子体质谱(ICP–MS)法测定无机杂质含量。最终确定间二氯苯的纯度为99.60%,扩展不确定度为0.03%(k=2)。该方法测定结果准确可靠,具有可溯源性。
The purity of m-dichlorobenzene was obtained by determination of the impurity content in m-dichlorobenzene sample. High performance liquid chromatography (HPLC-UVD) and gas chromatography (GC-FID) method were employed to determine the main impurities,the results indicated that o-dichlorobenzene and p-dichlorobenzene content detected by two methods were consistent. HPLC (UVD) method was used to determine the content of benzene, the moisture content was obtained by Karl Fischer method, TGA method was used for ash analysis and ICP-MS method was used for determining the inorganic impurities. The purity of m-dichlorobenzene was 99.60%with expanded uncertainty of 0.03%(k=2). The result determinied by the method is accurate and has traceability.

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通过红外光光谱测定、XRD检测等测试方法分析了稀土矿浸出过程中各种矿物表面性质的变化,稀土离子及铝、铁杂质离子与浸出剂和抑制剂的浸出交换过程及规律。结果表明,抑制剂的添加会与稀土矿中的铝、铁等杂质离子反应,形成化合物,从而降低浸出母液中铝、铁杂质离子含量,但不会影响离子型稀土的交换浸出过程。在机理分析的基础上,采用对铝铁杂质有高效抑制效果的抑杂剂LG-01进行离子型稀土矿抑制铝铁杂质的浸出实验研究。结果表明,在不影响离子型稀土矿稀土离子浸出率的情况下,LG-01能有效降低离子型稀土矿浸出母液中铝、铁等杂质离子含量,去除率可达92%。
Ion-absorbed rare-earth ore is an important mineral resource which is widely extracted by in-situ leaching process. And such process generates a significant amount of impurities such as aluminum and iron ions in leaching solution simultaneously. The surface characteristics and interactions by infrared spectroscopy and X-ray diffraction were studied to optimize the leaching conditions. It is found that the environment-friendly depressant LG-01 can react with the impurity ions through the formation of a new complex on the surface of leaching residues. Thus, it reduces significantly the concentration of impurity ions in leaching solution and improves the leaching rate of rare-earth ore. Moreover, a leaching rate of 95.6%and an impurity removal rate of 92%have been achieved under the optimized conditions.

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