干燥失重测定法标准操作规程

干燥失重测定法 标准 excel标准偏差excel标准偏差函数exl标准差函数国标检验抽样标准表免费下载红头文件格式标准下载 操作规程 1.目的 建立干燥失重检验标准操作规程，为干燥失重检验提供依据。 2.范围 QC检验人员 3.责任 QC检验人员严格按照检验操作规程进行检验和完成相关的记录 4.内容: 4.1定义:药品的干燥失重系指药品在规定的条件下，经干燥后，所失的重量，主要是指水 分、结晶水，亦包括其他挥发性的物质。 干燥失重的检查，应根据药物的性质、含水情况，选择适当的方法进行测定。本标准规定了 三种测定干燥失重的方法。 4.2第一法 常压恒温干燥法 4.2.1应用范围 本法适用于受热较稳定的供试品。 4.2.2原理 在常压和规定温度下，用电热干燥箱将供试品干燥至恒重。 4.2.3试剂 a)变色硅胶; b)硫酸 4.2.4仪器设备 a)电热干燥箱(最高使用温度250,300?); b)分析天平(万分之一); electricity at no cost, revenue from electricity sales. Poverty alleviation to the removal, to desperate farmers out of poverty, in conjunction with urbanization, new communities are centrally placed. Poverty in the enterprise, enterprise more powerful, more social responsibility, they should allow more people to enjoy the fruits of development. Conditions to encourage private enterprises to establish Charity Fund for poverty alleviation, employment, grants, financial aid and other forms of poverty alleviation activities, let poverty alleviation aid corporate social responsibility in the specific embodiment, the proper meaning of giving back to the community. Finally reveals to implement poverty alleviation policies, older age, incapacity, cannot be achieved through industry support and employment support, such as poverty, children and unable to support the poor, Lo-Fi policy reveals the role to play, eventually incorporated into the low range, and fundamentally solve the problem of poverty. (C) establishing and perfecting retreat mechanism. Poverty alleviation is a dynamic project, we must strengthen the farmers ' information management, dynamic management of poor, really "poor" no place to hide, "poverty" a timely exit, "poor" and "return to the poor" get maximum support and help. To build up the information network system of the poor, poverty the basic information and dynamic entry to the system, to implement dynamic management. According to pro-poor development, timely adjustment on c)扁形称量瓶; d)干燥器 4.2.5操作方法 取供试品，混合均匀(如为较大的结晶,应先迅速捣碎使成2mm以下的小粒)。取约1g 或各药品项下规定的重量，置与供试品同样条件下干燥至恒重的扁形称瓶中，精密称定， 除另有规定外，照各药品项下规定的条件干燥至恒重。从减失的重量和取样量计算供试 品的干燥失重。 供试品干燥时，应平铺在扁形称量瓶中，厚度不可超过5mm,如为疏松物质，厚度不 可超过10mm。放入烘箱或干燥器进行干燥时，应将瓶盖取下，置称量瓶旁，或将瓶盖半 开进行干燥;取出时，须将称量瓶盖好。置烘箱内干燥的供试品，应在干燥后取出置干 燥器中放冷至室温，然后称定重量。 4.3第二法 减压恒温或减压干燥剂干燥法 4.3.1应用范围 本法适用于较难烘出水分及低熔点，受热不稳定的供试品。 4.3.2原理 在温度低于100?(包括100?)、压力在2.67kpa一下并在五氧化二磷存在下，用电热减压干燥箱或减压干燥器，将供试品干燥至恒重。 4.3.3试剂 五氧化二磷、无水氯化钙或硅胶。 4.3.4仪器设备 a)分析天平(万分之一); b)扁形称量瓶; c)扁形称量瓶; d)干燥器 e)电热减压干燥箱，备有一个校正过数值的压力 表 关于同志近三年现实表现材料材料类招标技术评分表图表与交易pdf视力表打印pdf用图表说话 pdf 和温度计，减压干燥器，备有水银压力表; f)真空泵; g)干燥系统:由装有变色硅胶和浓硫酸的洗气瓶串联而成，连在减压干燥箱上。 4.3.5操作方法 将精密称量装有供试品的称量瓶(见4.2.5条)放在电热减压干燥箱内，同时放入装有五氧化二磷的培养皿，在规定温度下减压到2.67kpa以下，关闭真空活塞，关掉真空泵，并保持规定条件干燥至规定的时间或恒重。 缓缓打开真空活塞，使空气通过干燥系统进入干燥箱内，以免吹散供试品，直到恢复到常压electricity at no cost, revenue from electricity sales. Poverty alleviation to the removal, to desperate farmers out of poverty, in conjunction with urbanization, new communities are centrally placed. Poverty in the enterprise, enterprise more powerful, more social responsibility, they should allow more people to enjoy the fruits of development. Conditions to encourage private enterprises to establish Charity Fund for poverty alleviation, employment, grants, financial aid and other forms of poverty alleviation activities, let poverty alleviation aid corporate social responsibility in the specific embodiment, the proper meaning of giving back to the community. Finally reveals to implement poverty alleviation policies, older age, incapacity, cannot be achieved through industry support and employment support, such as poverty, children and unable to support the poor, Lo-Fi policy reveals the role to play, eventually incorporated into the low range, and fundamentally solve the problem of poverty. (C) establishing and perfecting retreat mechanism. Poverty alleviation is a dynamic project, we must strengthen the farmers ' information management, dynamic management of poor, really "poor" no place to hide, "poverty" a timely exit, "poor" and "return to the poor" get maximum support and help. To build up the information network system of the poor, poverty the basic information and dynamic entry to the system, to implement dynamic management. According to pro-poor development, timely adjustment on Shandong Boyuan Pharmaceutical CO., Ltd. 文件编号:QC2001 版本号:00 干燥失重测定法标准操作规程 File No Version No. Loss On Drying to cheack SOP 起草人/日期: 部门审核/日期: QA审核/日期: 批准人/日期: 页码: Drafted & Date Reviewed & Date QA Reviewed & Date Approved & Date Page 3/5 时，取出称量瓶，按4.2.5操作。 若供试品受热易分解，用装有五氧化磷、无水氯化钙或硅胶的减压干燥器干燥至恒重。 4.4第三法 常压干燥剂法 4.4.1应用范围 本品适用于受热分解且易挥发的供试品。 4.4.2原理 易挥发且遇热分解的供试品，置干燥器中，在常压下，利用干燥剂吸收水分干燥至恒重。 4.4.3试剂 五氧化二磷。 4.4.4仪器设备 a)分析天平(万分之一); b)干燥器; 4.4.5操作方法 将精密称量装有供试品的称量瓶(见4.2.5条)放入装有五氧化二磷的干燥器内，干燥至恒重，取出精密称定。 4.5注意事项 4.5.1变色硅胶使用过程中，如有蓝色变为粉红色，应将硅胶置105,110?烘箱内烘烤2h以上，至蓝色后，取出稍冷，放入干燥期内。 4.5.2硫酸使用前装入烧杯中加热至冒白烟，保持在110?左右约30min，冷却至70?以下，将硫酸倒入培养皿中，放入干燥器内，移动干燥器时，勿使硫酸溅出，每隔一定时间按上述方法处理一次。 4.5.3干燥系统用的硅胶和硫酸按上述方法处理。 4.5.4每个干燥器内放入称量瓶不得超过6个。 4.5.5五氧化二磷使用时可在培养皿内平铺一层，迅速放入干燥箱(或干燥器)内。使用后表层结块或出现液滴，应将表层刮去，添加一些新的五氧化二磷再继续使用。 弃去的五氧化二磷不要倒入下水道中，以防遇水剧烈反应和污染下水道，应埋入土中。 electricity at no cost, revenue from electricity sales. Poverty alleviation to the removal, to desperate farmers out of poverty, in conjunction with urbanization, new communities are centrally placed. Poverty in the enterprise, enterprise more powerful, more social responsibility, they should allow more people to enjoy the fruits of development. Conditions to encourage private enterprises to establish Charity Fund for poverty alleviation, employment, grants, financial aid and other forms of poverty alleviation activities, let poverty alleviation aid corporate social responsibility in the specific embodiment, the proper meaning of giving back to the community. Finally reveals to implement poverty alleviation policies, older age, incapacity, cannot be achieved through industry support and employment support, such as poverty, children and unable to support the poor, Lo-Fi policy reveals the role to play, eventually incorporated into the low range, and fundamentally solve the problem of poverty. (C) establishing and perfecting retreat mechanism. Poverty alleviation is a dynamic project, we must strengthen the farmers ' information management, dynamic management of poor, really "poor" no place to hide, "poverty" a timely exit, "poor" and "return to the poor" get maximum support and help. To build up the information network system of the poor, poverty the basic information and dynamic entry to the system, to implement dynamic management. According to pro-poor development, timely adjustment on 4.5.6减压干燥器初次使用时，用较厚的布包好再进行减压，一方炸裂伤人。 4.5.7五氧化二磷或硫酸减压干燥器，每次使用完毕，应减压后关闭活塞保存。 4.5.8供试品如未达到干燥温度即溶化时，应先将供试品置于较低的温度中干燥，除去大部分水分后，再按规定条件干燥。 4.5.9供试品如为膏状，可先在称量瓶中置一小玻璃棒及洗净的粗砂粒，在规定的条件下干燥至恒重，加入供试品精密称定，用玻璃棒搅匀，干燥过程中搅拌数次，直至恒重。 4.6结果计算 m-m 12 干燥失重(%)= ×100…………………….(2) m-m10 式中:m 空称量瓶质量，g; 0 m 干燥前称量瓶和供试品质量，g; 1 m 干燥后称量瓶和供试品质量，g。 2 5.附录 5.1相关文件和术语:无 5.2参考/翻译文本:《中华人民共和国药典》2010版 5.3历史和变更: 版本号 生效日期 文件修订内容 第00版 新文件生效 electricity at no cost, revenue from electricity sales. Poverty alleviation to the removal, to desperate farmers out of poverty, in conjunction with urbanization, new communities are centrally placed. Poverty in the enterprise, enterprise more powerful, more social responsibility, they should allow more people to enjoy the fruits of development. Conditions to encourage private enterprises to establish Charity Fund for poverty alleviation, employment, grants, financial aid and other forms of poverty alleviation activities, let poverty alleviation aid corporate social responsibility in the specific embodiment, the proper meaning of giving back to the community. Finally reveals to implement poverty alleviation policies, older age, incapacity, cannot be achieved through industry support and employment support, such as poverty, children and unable to support the poor, Lo-Fi policy reveals the role to play, eventually incorporated into the low range, and fundamentally solve the problem of poverty. (C) establishing and perfecting retreat mechanism. Poverty alleviation is a dynamic project, we must strengthen the farmers ' information management, dynamic management of poor, really "poor" no place to hide, "poverty" a timely exit, "poor" and "return to the poor" get maximum support and help. To build up the information network system of the poor, poverty the basic information and dynamic entry to the system, to implement dynamic management. According to pro-poor development, timely adjustment on