6个关键词拆解2020药典比表面及固体密度测试法
p style="text-indent: 24px text-align: justify "span style="font-family: 宋体 font-size: 16px "近日,国家药典委员会已颁布了最新的2020年版中国药典,并将于span style="font-family: Arial "2020/span年span style="font-family: Arial "12/span月span style="font-family: Arial "30/span日起正式实施。安东帕span style="font-family: Arial "-/span康塔特地对新鲜出炉的药典span style="font-family: Arial "0991/span比表面积测定法以及span style="font-family: Arial "0992/span固体真密度测定法进行解读,并针对不同的用户需求带来几款不同的仪器。/span/pp style="text-indent: 24px text-align: justify "span style="font-size: 16px "span style="font-family: 宋体 font-size: 16px "针对span style="font-size: 16px font-family: Arial "0991/span比表面积测定法,安东帕span style="font-size: 16px font-family: Arial "-/span康塔带来了span style="font-size: 16px font-family: Arial "Autoflow BET+/span、span style="font-size: 16px font-family: Arial "NOVAtouch/span、span style="font-size: 16px font-family: Arial "Quadrasorb evo/span以及span style="font-size: 16px font-family: Arial "Autosorb iQ/span。对于span style="font-size: 16px font-family: Arial "0992/span固体密度测定法,则有span style="font-size: 16px font-family: Arial "Ultrapyc5000/span系列可供选择。/spanspan style="font-size: 16px font-family: 宋体 text-indent: 24px "这些仪器的软件都可以选择专用于医药行业的版本,该版本符合/spanspan style="font-size: 16px text-indent: 24px font-family: Arial "21CFR Part 11/spanspan style="font-size: 16px font-family: 宋体 text-indent: 24px "的要求,方便数据呈现、溯源以及应对严格的医药产品审查。/span/span/ph1 label="标题居中" style="font-size: 32px font-weight: bold border-bottom: 2px solid rgb(204, 204, 204) padding: 0px 4px 0px 0px text-align: center margin: 0px 0px 20px "strongspan style="font-family: 宋体 color: rgb(204, 0, 0) font-size: 18px "一、0991比表面积测试法/span/strong/h1p style="text-indent: 24px text-align: justify "span style="font-size: 16px "span style="font-family: 宋体 "span style="font-family: 宋体 "此次/span0991span style="font-family: 宋体 "比表面积测定法主要有以下几个关键词:容量法/spanspan style="font-family: Arial "-N/span/spansubspan style="font-family: 宋体 vertical-align: sub "2/span/subspan style="font-family: 宋体 "span style="font-family: 宋体 "、容量法/span-Krspan style="font-family: 宋体 ",流动法,快速测试以及高通量。/span/span/span/pp style="text-indent: 24px text-align: justify "span style="font-size: 16px "strong style="text-indent: 2em "span style="font-family: 宋体 color: rgb(204, 0, 0) font-size: 19px "容量法-N/spansubspan style="font-family: 宋体 color: rgb(204, 0, 0) font-size: 19px vertical-align: sub "2/span/sub/strong/span/pp style="text-indent: 24px text-align: justify "span style="font-size: 16px "span style="font-family: 宋体 "span style="font-family: 宋体 "该方法是最常用的比表面积测试方法,中国药典/span2020span style="font-family: 宋体 "版要求在相对压力/spanspan style="font-family: Arial "P/P0/spanspan style="font-family: 宋体 "范围为/spanspan style="font-family: Arial "0.05-0.3/spanspan style="font-family: 宋体 "内至少进行/spanspan style="font-family: Arial "3/spanspan style="font-family: 宋体 "个压力点的测试,且/spanspan style="font-family: Arial "BET/spanspan style="font-family: 宋体 "方程相关系数需大于/spanspan style="font-family: Arial "0.9975/spanspan style="font-family: 宋体 "。安东帕/spanspan style="font-family: Arial "-/spanspan style="font-family: 宋体 "康塔旗下几乎所有物理吸附仪都可进行该方法的测试,其中/spanNOVAtouchspan style="font-family: 宋体 "、/spanspan style="font-family: Arial "Quadrasorb evo/spanspan style="font-family: 宋体 "以及/spanspan style="font-family: Arial "Autosorb iQ/spanspan style="font-family: 宋体 "这/spanspan style="font-family: Arial "3/spanspan style="font-family: 宋体 "款仪器都可以快速进行比表面积的测试,并且都配备单独的/spanspan style="font-family: Arial "P/span/spansubspan style="font-family: 宋体 vertical-align: sub "0/span/subspan style="font-family: 宋体 "span style="font-family: 宋体 "管以及/spanRTDspan style="font-family: 宋体 "(液位传感器/spanspan style="font-family: Arial ")/spanspan style="font-family: 宋体 "。/span/span/span/pp style="text-indent: 24px text-align: justify "span style="font-size: 16px "span style="font-family: 宋体 font-size: 13px "span style="font-size: 16px font-family: 宋体 "单独的/spanP/spansubspan style="font-family: 宋体 font-size: 13px vertical-align: sub "0/span/subspan style="font-family: 宋体 font-size: 13px "span style="font-size: 16px font-family: 宋体 "管可以实现饱和蒸汽压的连续测量,保证数据的稳定可靠。/spanRTDspan style="font-size: 16px font-family: 宋体 "(液位传感器/spanspan style="font-size: 16px font-family: Arial ")/spanspan style="font-size: 16px font-family: 宋体 "可以保证液氮不断挥发的情况下,系统内冷区体积恒定,保证了测试环境的相对连续、稳定。/span/span/span/pp style="text-indent: 24px text-align: justify "span style="font-size: 16px "span style="font-family: 宋体 font-size: 13px "span style="font-size: 16px font-family: 宋体 "另外这/span3span style="font-size: 16px font-family: 宋体 "台设备都配备了/spanspan style="font-size: 16px font-family: Arial "NOVA/spanspan style="font-size: 16px font-family: 宋体 "模式,可以节省样品管死体积的测试时间,从而加快测试速度。/span/spanspan style="font-family: Arial font-size: 13px text-indent: 24px " /span/span/pp style="text-indent: 24px text-align: justify "span style="font-size: 16px "strong style="text-indent: 2em "span style="font-size: 16px font-family: 宋体 color: rgb(204, 0, 0) "容量法-Kr/span/strong/span/pp style="text-indent: 24px text-align: justify "span style="font-size: 16px "span style="font-family: 宋体 "span style="font-family: 宋体 "与/spanN/spansubspan style="font-family: 宋体 vertical-align: sub "2/span/subspan style="font-family: 宋体 "span style="font-family: 宋体 "测试比表面积有/span2span style="font-family: 宋体 "个不同点:/span/span/span/pp style="text-indent: 24px text-align: justify "span style="font-size: 16px "span style="font-family: 宋体 "1、span style="font-family: 宋体 "当样品总表面积大于/span1m/spansupspan style="font-family: 宋体 vertical-align: super "2/span/supspan style="font-family: 宋体 "span style="font-family: 宋体 "时,可以使用容量法/span-N/spansubspan style="font-family: 宋体 vertical-align: sub "2/span/subspan style="font-family: 宋体 "span style="font-family: 宋体 ";当样品总表面积仅大于/span0.5m/spansupspan style="font-size: 16px font-family: 宋体 vertical-align: super "2/span/supspan style="font-family: 宋体 "span style="font-family: 宋体 "时,应选用容量法/span-Krspan style="font-family: 宋体 "。/span/span/span/pp style="margin-left: 0px text-indent: 24px text-align: justify "span style="font-size: 16px "span style="font-family: 宋体 "2、span style="font-family: 宋体 "容量法/span-N/spansubspan style="font-family: 宋体 vertical-align: sub "2/span/subspan style="font-family: 宋体 "span style="font-family: 宋体 "的压力范围为/span38 torr~228 torrspan style="font-family: 宋体 ";容量法/spanspan style="font-family: Arial "-Kr/spanspan style="font-family: 宋体 "的压力范围为/spanspan style="font-family: Arial "0.1315 torr~0.789 torr/spanspan style="font-family: 宋体 "。/span/span/span/pp style="text-indent: 27px text-align: justify "span style="font-family: 宋体 font-size: 16px "这两个不同点说明了容量法-Kr是用于小比表面积样品的精密测试方法。span style="font-size: 16px font-family: Arial "Quadrasorb evo/span以及span style="font-size: 16px font-family: Arial "Autosorb iQ/span特别适用于进行span style="font-size: 16px font-family: Arial "Kr/span气吸附。他们都配备了span style="font-size: 16px font-family: Arial "1 torr/span的高精密压力传感器以及分子泵,可以分辨极低压力环境下细微的压力变化,从而保证数据精确且稳定。/span/pp style="text-indent: 27px text-align: justify "span style="font-size: 16px "strong style="text-indent: 2em "span style="font-size: 16px font-family: 宋体 color: rgb(204, 0, 0) "流动法/span/strong/span/pp style="text-indent: 24px text-align: justify "span style="font-size: 16px "span style="font-family: 宋体 font-size: 13px "span style="font-size: 16px font-family: 宋体 "与容量法不同,流动法需要/spanspan style="font-family: 宋体 font-size: 16px "2/spanspan style="font-size: 16px font-family: 宋体 "种气体。一种为载气,即氦气;另一种为被吸附气体(吸附质),可以是/spanspan style="font-size: 16px font-family: Arial "N/span/spansubspan style="font-family: 宋体 font-size: 13px vertical-align: sub "2/span/subspan style="font-family: 宋体 font-size: 13px "span style="font-size: 16px font-family: 宋体 "也可以是/spanKrspan style="font-size: 16px font-family: 宋体 "。通过调节混合气体中的吸附质与载气的比例,即可获得不同的/spanspan style="font-size: 16px font-family: Arial "P/P/span/spansubspan style="font-family: 宋体 font-size: 13px vertical-align: sub "0/span/subspan style="font-family: 宋体 font-size: 13px "span style="font-size: 16px font-family: 宋体 "。混合气体在液氮温度下被样品吸附,在常温下被脱附出来,最后经过/spanTCDspan style="font-size: 16px font-family: 宋体 "产生信号得到脱附峰。根据峰面积的大小即可计算吸附量。/span/span/span/pp style="text-indent: 24px text-align: justify "span style="font-family: 宋体 font-size: 16px "Autoflow BET+即是为流动法所打造的一款精密仪器。其操作直观简易,一键即可开始分析并自动生成测试报告。不仅如此,span style="font-size: 16px font-family: Arial "Autoflow BET+/span最值得称道的是其分析速度,可在5分钟之内完成一个单点span style="font-size: 16px font-family: Arial "BET/span分析;span style="font-size: 16px font-family: Arial "15/span分钟内完成span style="font-size: 16px font-family: Arial "1/span个多点span style="font-size: 16px font-family: Arial "BET/span分析;每小时可以完成多达span style="font-size: 16px font-family: Arial "36/span个样品分析。/span/pp style="text-indent: 24px text-align: justify "span style="font-size: 16px "strong style="text-indent: 2em "span style="font-size: 16px font-family: 宋体 color: rgb(204, 0, 0) "快速测试/span/strong/span/pp style="text-indent: 24px text-align: justify "span style="font-size: 16px "span style="font-family: 宋体 "BETspan style="font-family: 宋体 "比表面积测试的时间较长,中国药典/span2020span style="font-family: 宋体 "版要求在使用容量法进行/spanspan style="font-family: Arial "BET/spanspan style="font-family: 宋体 "比表面积测试时,需要测试至少/spanspan style="font-family: Arial "3/spanspan style="font-family: 宋体 "个压力点。安东帕则一直致力于又快又好地为用户进行样品测试,容量法仪器,/span例如NOVAtouchspan style="font-family: 宋体 "、/spanspan style="font-family: Arial "Quadrasorb evo/spanspan style="font-family: 宋体 "等,都致力于节省分析时间、提高分析效率,软件和硬件的优化使其与常规仪器相比可以节省/spanspan style="font-family: Arial "30%~50%/spanspan style="font-family: 宋体 "的分析时间。如果使用效率更高的流动法仪器如/spanspan style="font-family: Arial "Autoflow BET+/spanspan style="font-family: 宋体 ",可以节省更多的时间。/span/spanspan style="font-family: 宋体 text-indent: 24px " /span/span/pp style="text-indent: 24px text-align: justify "span style="font-size: 16px "strong style="text-indent: 2em "span style="font-size: 16px font-family: 宋体 color: rgb(204, 0, 0) "高通量/span/strong/span/pp style="text-indent: 24px text-align: justify "span style="font-size: 16px "span style="font-family: 宋体 "span style="font-family: 宋体 "对于企业客户来说,样品分析数量同测试速度一样重要。/spanAutoflow BET+span style="font-family: 宋体 "可以同时进行/spanspan style="font-family: Arial "3/spanspan style="font-family: 宋体 "个样品的测试;/spanspan style="font-family: Arial "Autosorb-iQ/spanspan style="font-family: 宋体 "也可以同时进行/spanspan style="font-family: Arial "3/spanspan style="font-family: 宋体 "个样品的测试;/spanspan style="font-family: Arial "NOVAtouch/spanspan style="font-family: 宋体 "可以实现/spanspan style="font-family: Arial "4/spanspan style="font-family: 宋体 "个样品同时测试;/spanspan style="font-family: Arial "Quadrasorb evo/spanspan style="font-family: 宋体 "则可以同时测试/spanspan style="font-family: Arial "4/spanspan style="font-family: 宋体 "个不同类型的样品,其/spanspan style="font-family: Arial "4/spanspan style="font-family: 宋体 "个分析站相互独立避免了单杜瓦系统需要等待所有样品测定完成才能进行下一批样品分析的限制。/span/spanspan style="font-family: Arial text-indent: 24px " /span/span/pp style="text-align:center"span style="font-family: Arial text-indent: 24px font-size: 16px "img style="max-width:100% max-height:100% " src="https://img1.17img.cn/17img/images/202007/uepic/fbeed18f-f483-4237-bac5-07394fba884e.jpg" title="6个关键词拆解2020药典比表面及固体密度测试法1.png" alt="6个关键词拆解2020药典比表面及固体密度测试法1.png"//span/pp style="text-align: center "span style="font-size: 16px "strongspan style="font-family: 宋体 font-size: 13px "span style="font-size: 16px font-family: 宋体 "图/span1 /span/stronga href="https://www.instrument.com.cn/netshow/SH101011/Product-C0-39492-0-1.htm" target="_self"span style="font-size: 16px color: rgb(0, 176, 240) "strongspan style="font-size: 16px font-family: 宋体 "安东帕/span/strongstrongspan style="font-size: 16px font-family: 宋体 "比表面积测试仪家族/span/strong/span/a/span/pp style="text-indent: 24px text-align: justify "span style="font-size: 16px "span style="font-family: 宋体 "span style="font-family: 宋体 "综上,如图/span2span style="font-family: 宋体 ", /spanspan style="font-family: Arial "NOVAtouch/spanspan style="font-family: 宋体 "适用于样品比表面积较大且种类较为单一的客户进行快速测试,/spanspan style="font-family: Arial "Quadrasorb evo/spanspan style="font-family: 宋体 "以及/spanspan style="font-family: Arial "Autosorb-iQ/spanspan style="font-family: 宋体 "不但可以进行容量法/spanspan style="font-family: Arial "-N/span/spansubspan style="font-family: 宋体 vertical-align: sub "2/span/subspan style="font-family: 宋体 "span style="font-family: 宋体 ",也可以进行容量法/span-Krspan style="font-family: 宋体 "来对小比表面积的样品进行测试。/spanspan style="font-family: Arial "Quadrasorb evo/spanspan style="font-family: 宋体 "对样品通量进行了特化,尤其适合样品较为多样的客户。/spanspan style="font-family: Arial "Autoflow BET+/spanspan style="font-family: 宋体 "则是流动法的全能手,可以进行/spanspan style="font-family: Arial "N/span/spansubspan style="font-family: 宋体 vertical-align: sub "2/span/subspan style="font-family: 宋体 "span style="font-family: 宋体 "及/spanKrspan style="font-family: 宋体 "的快速分析。其分析效率高,速度快,数据准确且稳定。/span/spanspan style="font-family: Arial " /span/span/pp style="text-align:center"span style="font-family: Arial font-size: 16px "img style="max-width:100% max-height:100% " src="https://img1.17img.cn/17img/images/202007/uepic/728e5ab4-73b4-4e8f-a838-b904738e6f2f.jpg" title="6个关键词拆解2020药典比表面及固体密度测试法2.jpg" alt="6个关键词拆解2020药典比表面及固体密度测试法2.jpg"//span/pp style="text-align: center text-indent: 0em "span style="font-size: 16px "strongspan style="font-family: 宋体 font-size: 13px "span style="font-size: 16px font-family: 宋体 "图/span2:span style="font-size: 16px font-family: 宋体 "安东帕/spanspan style="font-size: 16px font-family: Arial "-/spanspan style="font-size: 16px font-family: 宋体 "康塔产品适用范围/span/span/strong/span/ph1 label="标题居中" style="font-size: 32px font-weight: bold border-bottom: 2px solid rgb(204, 204, 204) padding: 0px 4px 0px 0px text-align: center margin: 0px 0px 20px "span style="font-family: 宋体 color: rgb(204, 0, 0) font-size: 18px "二、0992固体密度测试法/span/h1p style="text-indent: 24px text-align: justify "span style="font-size: 16px "strong style="text-indent: 2em "span style="font-family: 宋体 color: rgb(204, 0, 0) "关键词:真密度/span/strong/span/pp style="text-indent: 24px text-align: justify "span style="font-family: 宋体, SimSun font-size: 16px "关于固体密度,0992固体密度测定法中定义了3种固体密度的表示方法,分别为真密度、颗粒密度以及堆密度,并且就真密度的测定方法进行了详细阐述。/span/pp style="text-indent: 24px text-align: justify "span style="font-family: 宋体, SimSun font-size: 16px "此次药典规定的真密度测定法又称气体置换法,即在测定颗粒密度时,假设在一封闭体系中,测试气体被样品置换掉的体积等同于样品本身体。若样品不含测试气体无法进入的空隙或密封针孔,则所得密度应与真密度一致。/span/pp style="text-indent: 24px text-align: justify "span style="font-family: 宋体, SimSun font-size: 16px "span style="font-family: 宋体 font-size: 13px "span style="font-size: 16px font-family: 宋体 "安东帕/span-span style="font-size: 16px font-family: 宋体 "康塔的真密度仪/spanspan style="font-size: 16px font-family: Arial "Ultrapyc5000/spanspan style="font-size: 16px font-family: 宋体 ",集/spanspan style="font-size: 16px font-family: Arial "TruPyc /spanspan style="font-size: 16px font-family: 宋体 "技术、/spanspan style="font-size: 16px font-family: Arial "TruLock /spanspan style="font-size: 16px font-family: 宋体 "样品池密封技术以及/spanspan style="font-size: 16px font-family: Arial "Peltier/spanspan style="font-size: 16px font-family: 宋体 "温控技术于一身!一台仪器配备不同大小的样品池满足/span/spanspan style="font-size: 16px font-family: 宋体 "客户不同的测试需求!/span/span/pp style="text-indent: 24px text-align: justify "span style="font-family: 宋体, SimSun font-size: 16px "span style="font-family: 宋体 font-size: 13px "span style="font-size: 16px font-family: 宋体 "该款仪器输出结果可精确至/spanspan style="font-family: 宋体 font-size: 16px "0.0001g/cm3/spanspan style="font-size: 16px font-family: 宋体 ",可在/span/spanspan style="font-family: Arial font-size: 16px "15/spanspan style="font-size: 16px font-family: 宋体 "至/spanspan style="font-family: Arial font-size: 16px "50° C/spanspan style="font-size: 16px font-family: 宋体 "范围内将温度控制在目标温度/spanspan style="font-family: 宋体, SimSun font-size: 16px "span style="font-family: 宋体 "± /spanspan style="font-family: Arial "0.05 ° C/span/spanspan style="font-size: 16px font-family: 宋体 "内。每个分析池均配备/spanspan style="font-family: 宋体, SimSun font-size: 16px "span style="font-family: 宋体 "10 cmsup3/supspan style="font-family: 宋体 "、/spanspan style="font-family: Arial "50 cmsup3/sup/spanspan style="font-family: 宋体 "、/spanspan style="font-family: Arial "135 cm/span/spanspan style="font-family: 宋体 vertical-align: super "3/span/spanspan style="font-family: 宋体 font-size: 16px "3/spanspan style="font-size: 16px font-family: 宋体 "种不同规格的分析样品池以及相应的校正钢球,分别适合不同样品量的客户。/span/span/pp style="text-indent: 24px text-align: justify "span style="font-family: 宋体, SimSun font-size: 16px "span style="font-family: 宋体 font-size: 13px "span style="font-size: 16px font-family: 宋体 "仪器支还持/spanspan style="font-family: 宋体 font-size: 16px "He/spanspan style="font-size: 16px font-family: 宋体 "、/span/spanspan style="font-size: 16px font-family: 宋体, SimSun "span style="font-size: 16px "N/spansubspan style="font-size: 13px vertical-align: sub "2/span/subspan style="font-size: 16px "、/span/spanspan style="font-family: 宋体, SimSun font-size: 16px "span style="font-family: 宋体 "SF/spansubspan style="font-family: 宋体 vertical-align: sub "6/span/sub/spanspan style="font-size: 16px font-family: 宋体 "以及其他非腐蚀气体,完全满足药典要求。同时,该款仪器可以选配真空泵。真空泵可以实现真空脱气加快挥发性物质的析出,特别适用于长时间的样品测试。/span/span/pp style="text-align:center"img style="max-width:100% max-height:100% " src="https://img1.17img.cn/17img/images/202007/uepic/d347b01f-fa80-41ca-9a7a-b1f8e5643024.jpg" title="6个关键词拆解2020药典比表面及固体密度测试法3.jpg" alt="6个关键词拆解2020药典比表面及固体密度测试法3.jpg"//pp style="text-align: center "span style="font-size: 16px "strongspan style="font-family: 宋体 font-size: 13px "span style="font-size: 16px font-family: 宋体 "图/span3:a href="https://www.instrument.com.cn/netshow/SH101011/C392579.htm" target="_self"span style="font-family: 宋体 font-size: 13px color: rgb(0, 176, 240) "span style="font-size: 16px font-family: 宋体 "康塔真密度仪/spanspan style="font-size: 16px font-family: Arial "Ultrapyc5000/span/span/a/span/strong/span/pp style="text-align: right "span style="font-family:Arial"strong作者:周琰/strong/span/pp style="text-align: right "span style="font-family:Arial"strong安东帕材料表征产品经理/strong/span/p