（上接《IS0/TC8与IM0要求的关系及其国际标准-2》[1-2]）ISO16437：2012 船舶与海上技术-救生与防火-船舶油雾探测器（Ships and marine technology-Lifesaving and fire protection--Atmospheric oil mist detectors for
详细梳理了新版国际标准ISO 80601-2-84:2020 Medical electrical equipment—Part 2-84:Particular requi-rements for basic safety and essential performance of ventilators for the emergency medical services environment,比较...详细梳理了新版国际标准ISO 80601-2-84:2020 Medical electrical equipment—Part 2-84:Particular requi-rements for basic safety and essential performance of ventilators for the emergency medical services environment,比较了ISO 80601-2-84:2020与ISO 10651-3:1997 Lung ventilators for medical use—Part 3:Particular requirements for emergency and transport ventilators的差异,分析了新版国际标准对工作数据准确性、危险输出的防护、呼吸机系统、使用环境等几方面的要求,可为生产企业和检验技术人员正确理解标准条款的要求和内涵提供参考。展开更多
ISO 1496-3:1995, Series 1 Freight Containers—Specification and Testing, Part 3: Tank Containers for Liquids, Gases and Pressurized Dry Bulk, hereinafter abbreviated "1995 edition". ISO 1496-3:1995 AMENDMENT...ISO 1496-3:1995, Series 1 Freight Containers—Specification and Testing, Part 3: Tank Containers for Liquids, Gases and Pressurized Dry Bulk, hereinafter abbreviated "1995 edition". ISO 1496-3:1995 AMENDMENT 1 2006-02-01, hereinafter abbreviated "amd.1:2006"."Recommendation of Transport of Dangerous Goods, Manual of Tests and Criteria", the fourth version Amendment 1:2005,展开更多
建立了有效分离重组人胰岛素注射液中B3和B3iso脱氨人胰岛素的反相高效液相色谱(RP-HPLC)法,并采用高效液相色谱-四极杆-飞行时间质谱联用技术(HPLC-MS/MS)对其进行氨基酸序列的鉴定。在《中国药典》2010版重组人胰岛素注射液有关物质...建立了有效分离重组人胰岛素注射液中B3和B3iso脱氨人胰岛素的反相高效液相色谱(RP-HPLC)法,并采用高效液相色谱-四极杆-飞行时间质谱联用技术(HPLC-MS/MS)对其进行氨基酸序列的鉴定。在《中国药典》2010版重组人胰岛素注射液有关物质检查分析方法的基础上,优化流动相p H值,以0.2mol/L硫酸盐缓冲液(p H 3.6)-乙腈(90∶10)作为A相,乙腈-水(50∶50)为B相,梯度洗脱,分别收集杂质峰1和杂质峰2,脱盐浓缩后,用丝氨酸蛋白酶(V8酶)酶切,取部分酶切溶液经三(2-羧乙基)膦盐酸盐(TCEP)还原,分别得到还原和非还原肽段溶液,利用LC-MS/MS鉴定氨基酸序列,未知杂质分别为重组人胰岛素B3位发生脱氨和异构化的产物,即B3和B3iso脱氨人胰岛素。将优化后的方法与《中国药典》方法对市售重组人胰岛素注射液进行有关物质的对比分析,已上市厂家的重组人胰岛素注射液均有不同程度的B3和B3iso脱氨人胰岛素存在。该方法不影响重组人胰岛素其它有关物质的检测,可用于监控人胰岛素注射液产品储存过程中脱氨类杂质的增长趋势。展开更多
文摘（上接《IS0/TC8与IM0要求的关系及其国际标准-2》[1-2]）ISO16437：2012 船舶与海上技术-救生与防火-船舶油雾探测器（Ships and marine technology-Lifesaving and fire protection--Atmospheric oil mist detectors for
文摘详细梳理了新版国际标准ISO 80601-2-84:2020 Medical electrical equipment—Part 2-84:Particular requi-rements for basic safety and essential performance of ventilators for the emergency medical services environment,比较了ISO 80601-2-84:2020与ISO 10651-3:1997 Lung ventilators for medical use—Part 3:Particular requirements for emergency and transport ventilators的差异,分析了新版国际标准对工作数据准确性、危险输出的防护、呼吸机系统、使用环境等几方面的要求,可为生产企业和检验技术人员正确理解标准条款的要求和内涵提供参考。
文摘ISO 1496-3:1995, Series 1 Freight Containers—Specification and Testing, Part 3: Tank Containers for Liquids, Gases and Pressurized Dry Bulk, hereinafter abbreviated "1995 edition". ISO 1496-3:1995 AMENDMENT 1 2006-02-01, hereinafter abbreviated "amd.1:2006"."Recommendation of Transport of Dangerous Goods, Manual of Tests and Criteria", the fourth version Amendment 1:2005,
文摘建立了有效分离重组人胰岛素注射液中B3和B3iso脱氨人胰岛素的反相高效液相色谱(RP-HPLC)法,并采用高效液相色谱-四极杆-飞行时间质谱联用技术(HPLC-MS/MS)对其进行氨基酸序列的鉴定。在《中国药典》2010版重组人胰岛素注射液有关物质检查分析方法的基础上,优化流动相p H值,以0.2mol/L硫酸盐缓冲液(p H 3.6)-乙腈(90∶10)作为A相,乙腈-水(50∶50)为B相,梯度洗脱,分别收集杂质峰1和杂质峰2,脱盐浓缩后,用丝氨酸蛋白酶(V8酶)酶切,取部分酶切溶液经三(2-羧乙基)膦盐酸盐(TCEP)还原,分别得到还原和非还原肽段溶液,利用LC-MS/MS鉴定氨基酸序列,未知杂质分别为重组人胰岛素B3位发生脱氨和异构化的产物,即B3和B3iso脱氨人胰岛素。将优化后的方法与《中国药典》方法对市售重组人胰岛素注射液进行有关物质的对比分析,已上市厂家的重组人胰岛素注射液均有不同程度的B3和B3iso脱氨人胰岛素存在。该方法不影响重组人胰岛素其它有关物质的检测,可用于监控人胰岛素注射液产品储存过程中脱氨类杂质的增长趋势。
