金币
UID68730
帖子
主题
积分1848
注册时间2013-1-3
最后登录1970-1-1
听众
性别保密
|
发表于 2013-4-8 20:33:47
|
显示全部楼层
有人已经翻译好了
我摘录一点吧
附件3：紫外-可见光分光光度仪的确认
Full document title and reference
文件全名和索引号
Qualification of Equipment
Annex 3: Qualification of UV-Visible spectrophotometers
PA/PH/OMCL (07) 11 DEF CORR
Document type 文件类型
Guideline 指南
Legislative basis 立法基础
The present document was also accepted by EA as recommendation document to be used in the context of Quality Management System audits of OMCLs
Date of first adoption
首次发行日期
May 2007
Date of original entry into force
首次执行日期
July 2007
Date of entry into force of revised document 修订后执行日期
December 2007
Previous titles/other references
原文件名/其它索引号
This document replaces document PA/PH/OMCL (07) 11DEF
Custodian Organisation
保管机构
The present document was elaborated by the OMCL Network/ EDQM of the Council of Europe
Concerned Network
相关网络
GEON
ANNEX 3 OF THE OMCL NETWORK GUIDELINE
“QUALIFICATION OF EQUIPMENT”
OMCL网络指南“仪器确认”附件3
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETERS
紫外-可见光分光光度仪的确认
Introduction
The present document is the third Annex of the core document “Qualification of Equipment”, and it should be used in combination with it when planning, performing and documenting the UV-Visible spectrophotometer qualification process.
本文件是核心文件“仪器的确认”的第三个附件，在计划、实施和记录紫外-可见光分光光度计的确认时应与该核心文件结合使用。
The core document contains the Introduction and general forms for Level I and II of qualification, which are common to all type of instruments.
核心文件包括了对第一级和第二级确认的介绍和一般表格，它们适用于所有类型的仪器。
For UV-Visible spectrometers, an example has been added to give instrument-specific proposals that may be used in combination with the general requirements presented in the core document “Qualification of Equipment”, when drawing up a Level I checklist.
对于紫外-可见光分光光度计，增加了一个例表给出仪器相关的方案，可以在规划第一级检查清单时，与核心文件里的通用要求“仪器的确认”结合使用。
The present annex contains instrument-related recommendations on parameters to be checked at Level III and IV of qualification and the corresponding typical acceptance limits, as well as practical examples on the methodology that can be used to carry out these checks.
本附件包括了仪器相关的推荐，其中有第三级和第四级需要检查的参数和对应的典型可接受限度，以及一些可以实施这些检查项目的实践举例。
TABLE I 表一
Level I. Selection of instruments and suppliers 第一级 仪器和供应商选择
Example of check-list (non-exhaustive) 检查清单举例（非完全清单）
Manufacturer: 生产商
Provider/Distributor: 供应商/分销商
Name of instrument and type: 仪器名称和型号
Attribute 特性
(this list may be adapted if necessary)
（必要时可以采用本清单）
Specifications 标准
Benefits
益处
(instrument/
suppliers )
（仪器/供应商）
Assessment
评价
Pass
通过
Fails
不通过
Spectrophotometer 光度计
Single beam and double beam model 单光束和双光束模式
Allow both modes
允许双模式
Wavelength range 波长范围
190-900nm
Photometric range 光度计范围
Minimum 2.0 absorbance
(Abs.) unit
Lamp switching 灯开关
Allow both modes manual or automatic 允许双模式：手动和自动
Band width 波段宽
0.2-4.0nm or better with 0.1nm for increments
0.2-4.0nm或更好，以0.1nm为步距变化
Automatic baseline corrections
自动基线校正
Must
必须有
Wavelength accuracy
波长准确性
Minimum of ±0.2nm
最小±0.2nm
Wavelength reproducibility
波长重复性
0.05nm or better
0.05nm或更好
Wavelength resolution
波长分辨率
0.2nm or better
0.2nm或更好
Photometric accuracy
光度计准确度
±0.003 Abs. units or better for 1.0Abs. units
Photometric stability
光度计稳定性
After 2 hours should not be more than 0.0005Abs. units/h
Photometric reproducibility
光度计重复性
Should not be more than 0.0005 Abs. units at 0.5 Abs. units
在0.5Abs.单位时应不大于0.0005Abs。
Photometric noise
光度计噪音
Should not be more than 0.0003 Abs. units at 1.0 Abs. units
在1.0Abs.单位时应不大于0.0003Abs.单位
Scan speed
扫描速度
Should be between 0.25nm/sec. and 8nm/sec. or better
应介于0.25nm/秒至8nm/秒之间或更好
Monochromator slew rate
单色器压摆率
Should be 1500nm/min. or better 应为1500nm/分钟或更好
Data acquisition and processing system
数据获得和处理系统
Acquisition at more than one wavelength 在不止一个波长获得数据
Minimum of two
最少2个
Photometric scaling in Abs. units, %T, log Abs. units and concentration
光度计刻度包括Abs.单位，T%，Abs.单位对数和浓度
Abscise scaling in nm, min., deg, and mm.
切除刻度包括纳米，分钟，度和毫米
Calibration at one or more levels and one or more wavelengths
在一个或多个水平，以及一个或多个波长进行校正
Calculate and give factor for linear regression and other
计算并给出线性回归因子和其它
Build and memorise in file form: data, method and report
创建并保存为文件形式：数据、方法和报告
Accessories 附件
Flow-through cuvette; holder for n cuvette(s)
流动池，比色皿支架可以放置多少比色皿
Thermostated cell holder (temperature range and stability)
可控温比色皿支架（温度范围和稳定性）
Filters for qualification checks
确认检查用滤片
Notes: 注
— This check-list, containing examples of attributes that can be taken into account in the selection of an instrument and supplier, can be used in combination with the general check-list presented in Level I in the core document “Qualification of Equipment”.
— 本检查清单，包括了特性举例，这些举例可以在仪器和供应商选择时参考，这份清单可以与核心文件“仪器的确认”中第一级通用检查清单结合使用。
— For Table II (Level II of Equipment Qualification: Installation and release for use) please refer to the core document.
— 对于表二（第二级仪器确认：安装和使用放行），请参见核心文件
TABLE III
Level III. Periodic and motivated instrument checks
Examples of requirements for UV-Visible spectrophotometers
Parameters to be checked
要检查的参数
Typical tolerance limits
典型允许限度
1. Spectral slit width (if applicable)
光狭缝宽度（如适用）
±10%
2. Wavelength accuracy
波长准确度
±1nm for the UV range
紫外光范围内±1nm
±3nm for the visible range
可见光范围内±1nm
3. Wavelength precision
波长精密度
See manufacturer’s specifications
见生产商规格
4. Photometric accuracy (control of absorbance)
光度计准确性（吸光度控制）
See annex I
见附件一
5. Photometric linearity
光度计线性
r2≥0.999
6. Limit of stray light
杂散光限度
A>2.0 at 198nm
7. Baseline noise
基线噪声
±0.002 Absorbance units (500nm) or或
±0.01 Absorbance units (200, 300, 400nm)
8. photometric drift
光度计飘移
±0.001 Absorbance units/h (250 nm) Or或
±0.002 Absorbance units/h (500 nm)
TABLE IV 表四
Level IV. In-use instrument checks 第四级 仪器使用中检查
Examples of requirements for UV-Visible spectrophotometers 紫外-可见分光光度计要求举例
Parameter to be checked
要检查的参数
Typical tolerance limits
典型允许限度
1. System suitability check of the method
方法系统适用性检查
— e.g. Repeatability 例如 重复性
— e.g. Resolution (if required for qualitative analysis) 例如 分辨率（如果定量分析需要的话）
According to Ph. Eur. or MAH dossier or validated in-house method
根据欧洲药典或MAH文件或经过验证的内控方法
2. Absorption cells
吸收池
Absorbance difference ≤0.005
吸光度差异≤0.005
ANNEX I 附件1
Level III. Periodic and motivated instrument checks
第三级 周期主动性仪器检查
This Annex contains practical examples of tests and their associated tolerance limits for several parameters related to the performance of a UV-Visible spectrophotometer.
本附件包括与紫外-可见光分光光度计性能有关的几个参数的检查实例及其相关的允许限度
These examples can be considered by the OMCLs as possible approaches to perform the Level III of the equipment qualification process: “Periodic and motivated instrument checks”.
这些例子可以认为是OMCL在实施第三级仪器确认“周期主动性仪器检查”的可行性方法
GENERAL CONSIDERATIONS 一般考虑
— Measurements made by comparing samples against external standards should be made under conditions during which temperature is held constant. This is particularly relevant where the carrier solvent is organic and measurements may be distorted by expansion or evaporation of the solvent.
— 如果测量需要将样品与外标进行比较，则检测过程应保证温度恒度。尤其是如果载液是有机溶剂，测量结果可能会因为溶剂的膨胀或汽化而变化时。
— It is recommended to perform the qualification within the spectral range corresponding to the region of analytical interest.
— 推荐根据分析范围所需进行光学范围确认
— Ensure that the spectrophotometer has stabilized, according to the manufacturer’s recommendations, before starting the qualification tests.
— 在进行确认检查前，应根据供应商的建议确保分光光度计稳定。
— When references are made to the European Pharmacopoeia, e.g. reagents R, then the reagent quality complies with the EP specifications.
— 如果引用了欧洲药典，例如试剂纯度的试剂，那么试剂的质量符合EP质量标准。
|
评分
-
查看全部评分
|
[复制链接]
|手机版|蒲公英|ouryao|蒲公英
( 京ICP备14042168号-1 ) 增值电信业务经营许可证编号：京B2-20243455 互联网药品信息服务资格证书编号：(京)-非经营性-2024-0033
置顶卡
变色卡
楼主
