OMCL设备确认附录7：质谱确认
作者：JULIA 来源：Julia法规翻译
PA/PH/OMCL (10) 86 R6 –OMCL设备确认附录7：质谱确认 201804 生效日期20180801
前版本：PA/PH/OMCL(10)86 2R 201107
ANNEX 7 OF THE OMCL NETWORKGUIDELINE
“QUALIFICATION OF EQUIPMENT”
QUALIFICATION OF MASSSPECTROMETERS
设备确认附录7：质谱仪的确认
衣服款式图
Note: Mandatory requirements in this guideline and its annexes are defined using the terms «shall» or «must».The u of «should» indicates are commendation. For the parts of the text other appropriately justified approaches a
re acceptable.The term «can» indicates a possibility or an example with non-binding character.
注：本指南及其附录中的强制要求采用术语“应”或“必须”进行定义。使用“应”表示是建议，其下所列要求可采用经过适当论证的其它方法来实施。术语“可”表示一种可能性，或非强制特性举例。
汤唯 英语Introduction 介绍
The prent document is the 7thAnnex of the core document “Qualification of Equipment” and it shall be ud incombination with it when planning, performing and documenting the qualificationprocess of Mass Spectrometers coupled with Chromatographic equipment.
本文件是核心文件“仪器确认”的第7个附件，在规划、实施和记录质谱确认过程中，应与核心文件结合使用。
The core document “Qualification ofEquipment” contains the introduction and general forms for Level I and II ofqualification, which are common to all type of instruments.
围裙英文
纽约时报官网核心文件“设备确认”包括了介绍和适用于所有类型仪器的第一级和第二级确认用通用表格。
The prent Annex 7 contains a generalintroduction and requirements for GC-EI-MS and LC-ESI-MS. Level III and IVqualifications must be carried out being an ISO 17025 requirement.
本附录7包括与GC-EI-MS和LC-ESI-MS有关的通用介绍和要求。必须执行第三级和第四级确认是ISO17025的要求。
Requirements and (if applicable)corresponding typical acceptance limits given in bold should be applied,however other appropriately justified deviations are acceptable provided theyare traceable.
应采用加粗的要求及（适用时）相应的典型可接受限度，但只要可以追溯，也可以接受其它经过适当论证的偏差。
Exemplary procedures provided in Annexeshave non-binding character. They can be help
ful to carry out the requiredqualification. Nevertheless, other procedures can be applied depending on the modelof the MS equipment.
在附录中给出的示范程序并非强制，它可能有助于执行所需的确认。但根据MS设备的型号不同，也可采用其它程序。
7.1: QUALIFICATION OF GASCHROMATOGRAPHY-MASS SPECTROMETERS WITH ELECTRON IMPACT IONIZATION (GC-EI-MS)
7.1：配有电子轰击电离的气相色谱-质谱仪（GC-EI-MS）的确认
TABLE I 表1
Level III.Periodic and motivated instrument checks
第三级周期性主动仪检查
GC-EI-MS
Requirements and related typical acceptancelimits are indicated in bold.
要求和相关典型可接受标准以粗体显示。
Parameter to be checked 要检查的参数 | Typical acceptance limits* 典型可接受限度 |
Mass accuracy 质量准确性 (PFTBA (FC-43) ** or internal calibration gas) PFTBA (FC-43)或内部校正气体 | m/z = 69±0.5 m/z = 219±0.5 m/z = 502±0.5 |
Linearity *** 线性 | Limit to be t up bad on OMCL experience/rvice provider instructions and type of regression mode chon 限度应基于OMCL经验/服务提供者指令和所选回归模式类型而设定 |
System/instrument precision ** 系统/仪器精密度 | RSD≤10.0% |
| |
*Otherfigures given under column of “typical acceptance limits” are typical valuesobtained when applying the exemplary procedures provided in annexes, thereforethe values are not binding.
其它“典型可接受标准”列所给数值为实施附录中所述示例程序时所得典型值，因此这些值并非强制要求。
** PFTBA (FC-43): Perfluoro-tributyl-amine(CAS NO.: 311-89-7)
PFTBA(FC-43): 全氟三丁胺（CAS号 311-89-7）
***To be checked when quantification isrequested.
如果要进行定量检测，这些参数必须要检查。
TABLE II 表2
Level IV.In-u instrument checks
第四级在用仪器的检查
GC-EI-MS
Requirements and related typical acceptancelimits are indicated in bold.
要求和相关典型可接受标准以粗体显示。
Parameter to be checked/ Typical acceptance limits
要检查的参数/典型可接受限度
According to specific analysis method or Ph. Eur. monograph or MAH dossier (e examples in Level IV, Annex II)
根据欧洲药典各论或MAH文件（见第四级附录2的举例）
ANNEX I 附录1
Level III.Periodic and motivated instrument checks
第三级周期性主动仪器检查
This Annex contains practical exemplaryprocedures for veral parameters related to the qualification of GC-EI-MS.
本附录中包括GC-EI-MS确认相关的几个参数的测试实例程序。
The examples can be considered by the OMCLsas possible approaches to perform the Level III of the equipment qualificationprocess: “Periodic and motivated instrument checks”.
这些实例可以作为OMCL在实施第三级仪器确认过程“周期性主动仪器检查”中可以采用的方法。
However, alternative procedures can beapplied.
当然，也可以使用替代程序。
GENERAL CONSIDERATION: GC-MS is mainly udfor the identification of unknown substances or quantification of lowconcentrated substances where high specificity is needed.
一般考虑：GC-MS主要用于需要较高专属性的未知物质的鉴别，或低浓度物质的定量。
MASS ACCURACY 质量准确度
Materials: 材料 | PFTBA (FC-43) or internal calibration gas PFTBA(FC-43)或内部校正气体 |
Method: 方法 | Internal instrument check or spectrum of PFTBA (FC-43) in full scan mode peach怎么读仪器内部检查或PFTBA（FC-43）全扫描模式光谱扫描 |
Limits: 限度 | As defined in Table I 按表1中所要求 |
| |
LINEARITY 线性
Materials: 材料 | Stock solutions: 1-Octanol in methanol at concentrations of 0.2, 0.4, 0.6, 0.8, 1.0 μL/mL 贮备液：浓度为0.2, 0.4, 0.6, 0.8, 1.0 μL/mL的正辛醇/甲醇溶液 |
加勒比海盗4字幕下载ethod: 分手挽回女友方法 | Injection volume: 1.0 μL (2 injections of each level) 进样量 1.0uL（每个水平2针） |
Limits: 限度 | kama Limit to be t up by OMCL bad on experience and type of regression mode chon 限度应基于OMCL经验/服务提供者指令和所选回归模式类型而设定unsv |
和风日语网 | |
NOTE:Linearity is typically performed in SIM/MRM, since this mode is normallyapplied forquantification of analytes in low concentration. 注：线性一般在SIM/MRM中执行，因为此模式通常适用于低浓度被测物定量检测。
