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EDQM發布《紫外-可見分光光度計確認指南》
近日(ri)，EDQM-OMCL發布《紫外(wai) - 可見分光(guang)(guang)(guang)光(guang)(guang)(guang)度計確認指南》，包(bao)含Level III定期及有(you)動機的儀器檢(jian)(jian)查(cha)(cha)、紫外(wai) - 可見分光(guang)(guang)(guang)光(guang)(guang)(guang)度計的建議及相關典型接(jie)受限(xian)、Level IV在用儀器檢(jian)(jian)查(cha)(cha)、一般注意事項、光(guang)(guang)(guang)譜狹縫寬(kuan)度（如適用）、波長精度、基線噪(zao)聲(sheng)、光(guang)(guang)(guang)度漂移等內容。文件將于9月1日(ri)生效。
ANNEX 3 OF THE OMCL NETWORK GUIDELINE “QUALIFICATION OF EQUIPMENT”
OMCL設備確認指南附(fu)錄(lu)3
QUALIFICATION OF UV - VISIBLE SPECTROPHOTOMETERS
紫外-可見(jian)分光光度計(ji)的確認
Note: Mandatory requirements in this annex are defined using the terms “shall” or “must”. The use of “should” indicates a recommendation. For these parts of the text other appropriately justified approaches are acceptable. The term “can” indicates a possibility or an example with non - binding character.
注：本(ben)附件中的(de)強(qiang)制性要求使用 “應(ying)” 或 “必須(xu)” 等(deng)詞來定(ding)義。“宜” 的(de)使用表示一(yi)(yi)種(zhong)建議。對(dui)于文本(ben)的(de)這些(xie)部分，其(qi)他有適當理由的(de)方法(fa)是可(ke)接受的(de)。“可(ke)” 一(yi)(yi)詞表示一(yi)(yi)種(zhong)可(ke)能性或一(yi)(yi)個不(bu)具約束力的(de)示例。
Table of Contents
目錄
Introduction
簡介
Level III. Periodic and motivated instrument checks
三(san)級：定期及有動機的儀器檢(jian)查
Recommendations for UV - visible spectrophotometers and related typical acceptance limits
紫外 - 可見分光光度(du)計的建議及相關典型接(jie)受(shou)限(xian)
Level IV. In - use instrument checks
四級：使用中(zhong)儀器(qi)檢查
Recommendations for UV - visible spectrophotometers and related typical acceptance limits
紫外(wai) - 可見分光光度計(ji)的建議及(ji)相(xiang)關典型接受限
Level III. Periodic and motivated instrument checks
三級：定(ding)期及有動機的儀器檢查(cha)
General Considerations
一般注意事項
Spectral Slit Width (if applicable)
光譜(pu)狹縫寬度（如適(shi)用）
Wavelength Precision (for mechanically set wavelengths)
波長精度(du)（對于機(ji)械(xie)設(she)定(ding)波長）
Baseline Noise
基線噪聲
Photometric Drift
光度漂移
Level IV. In - use instrument checks
四(si)級(ji)：使用中儀器檢(jian)查(cha)
Introduction
簡介
The present document is the 3rd Annex of the core document “Qualification of Equipment”, and it shall 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 “設備確認(ren)” 的第 3 個附件，在規(gui)劃(hua)、執行和記錄(lu)紫外 - 可(ke)見(jian)分光光度(du)計確認(ren)過程時，應(ying)與該核心文件結合使(shi)用。
The core document contains the Introduction and general forms for Level I (Selection of instruments and suppliers) and II (Installation and release for use) of qualification, which are common to all types of instruments.
核心文件包含一級（儀(yi)器(qi)和(he)(he)供應(ying)商的選擇）和(he)(he)二級（安裝和(he)(he)投入使用(yong)）確(que)認的簡介和(he)(he)通用(yong)表(biao)格，這些適用(yong)于所(suo)有類型(xing)的儀(yi)器(qi)。
The present Annex 3 contains the Introduction and requirements for UV - Visible spectrophotometers. Level III (Periodic and motivated instrument calibration/checks) and IV (In - use instrument checks) qualifications must be carried out being ISO/IEC 17025 requirement.
本附件 3 包含紫(zi)外 - 可見分(fen)光光度計的簡介(jie)和要(yao)求。三級（定期及(ji)有(you)動(dong)機的儀器(qi)校準 / 檢查(cha)）和四(si)級（使用中儀器(qi)檢查(cha)）確認必(bi)須按照 ISO/IEC 17025 要(yao)求進(jin)行(xing)。
Requirements (if applicable) corresponding typical acceptance limits given in bold should be applied; however other appropriately justified approaches are acceptable.
應(ying)采(cai)用（如適用）以(yi)粗(cu)體給出的(de)相應(ying)典型(xing)接(jie)受限；然而(er)，其(qi)他有適當(dang)理由的(de)方法也是可接(jie)受的(de)。
Exemplary procedures provided in this document have non - binding character. They can be helpful to carry out the required qualification. Nevertheless, it is left to the professional judgement and background experience of each OMCL to decide on the most relevant procedures to be undertaken in order to give evidence that their UV-Visible spectrophotometers are working properly and aresuitable for their intended use.
本文件中提供的示(shi)例程(cheng)序不(bu)具(ju)約束力。它們可能有(you)助于進行所需的確認。然(ran)而，由(you)每(mei)個 OMCL 根(gen)據專業判(pan)斷(duan)和背景經驗(yan)來決定采用最(zui)相關的程(cheng)序，以(yi)證明其(qi)紫外 - 可見分光(guang)光(guang)度計工作正常且(qie)適合其(qi)預期用途。
If the qualification of equipment is done by the manufacturer or an external service - provider, it is the responsibility of the OMC L to make sure that this is in line with the requirements set out in this guideline.
如果設備的確(que)認(ren)是(shi)由制造商或外部服務提供(gong)商完成的，那么 OMCL 有責任(ren)確(que)保其符合本指南中規定(ding)的要求。
Level III. Periodic and motivated instrument checks
三級 定期及有動(dong)機的儀器檢(jian)查(cha)
recommendations for UV - visible spectrometers and related typical acceptance limits
對(dui)紫外 - 可見(jian)分(fen)光(guang)光(guang)度計的(de)建議及相(xiang)關典型接(jie)受限(xian)度
EDQM發布《紫(zi)外-可見分光(guang)光(guang)度計確認指南》
following the instructions given in Ph. Eur. Chapter 2.2.25. "Control of equipment performance"
遵循(xun)《歐洲(zhou)藥典》第 2.2.25 章(zhang) “設(she)備性能控(kong)制” 中(zhong)給出的說明
Level IV. In - use instrument checks
四級 使用中儀器的檢查(cha)
Recommendations for UV - visible spectrophotometers and related typical acceptance limits
紫外 - 可(ke)(ke)見(jian)分(fen)光(guang)(guang)光(guang)(guang)度計的(de)建議以及相關典型(xing)的(de)可(ke)(ke)接(jie)受(shou)限度
EDQM發布《紫外-可見分(fen)光(guang)(guang)光(guang)(guang)度計確認指(zhi)南》
following the instructions given in Ph. Eur. Chapter 2.2.25. "Control of cuvettes"
按(an)照歐洲藥典第 2.2.25 章 “比色皿的控制” 中給出的說明操作
Level III. Periodic and motivated instrument checks
第三(san)級：定期及(ji)有動機(ji)的儀器(qi)檢查
This section contains practical examples of tests and their associated acceptance limits for several parameters related to the performance of a UV - visible spectrophotometer. These examples can be considered as the OPCs as possible approaches to perform the Level III of the equipment qualification process: "Periodic and motivated instrument checks".
本節包含了與紫(zi)外 - 可(ke)(ke)見(jian)分光(guang)光(guang)度計性能相關的(de)幾個(ge)參數的(de)測試實例(li)(li)及(ji)其相關的(de)合格限。這(zhe)些實例(li)(li)可(ke)(ke)被(bei)視為執行設備確認過程第三級(ji) “定期及(ji)有動機的(de)儀器檢查” 的(de)可(ke)(ke)能方法(fa)（即操作規范條件）。
1.General Considerations
一般注意事項
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.
通過將(jiang)樣品與外(wai)部標準進(jin)行比較而(er)進(jin)行的(de)(de)測量(liang)應在溫度保(bao)持恒定的(de)(de)條件(jian)下進(jin)行。這(zhe)在載液為(wei)有機(ji)溶劑(ji)且(qie)測量(liang)可(ke)能(neng)因(yin)溶劑(ji)的(de)(de)膨脹或蒸(zheng)發而(er)失真的(de)(de)情況下尤為(wei)重要。
It is recommended to perform the qualification within the spectral range corresponding to the region of analytical interest.
建議在與分(fen)析感興趣區域相對應的光譜范圍內進行確認。
Ensure that the spectrophotometer has stabilised, according to the manufacturer's recommendations, before starting the qualification tests.
根據制造商的建議(yi)，在開始確(que)認測試之前，確(que)保分光(guang)(guang)光(guang)(guang)度計(ji)已穩定(ding)。
When references are made to the European Pharmacopoeia, e.g. reagents R, then reagent quality shall comply with the Ph. Eur. specifications.
當引用(yong)《歐洲藥(yao)典》時，例如(ru)試劑(ji)(ji) R，那么試劑(ji)(ji)質量應符(fu)合《歐洲藥(yao)典》的規范。
When using commercial filters as alternative to the proposed tests, a set of filters covering the entire range of interest should be used. They should be calibrated with traceability to national/international standards, preferably through a national metrology laboratory or NIST.
當使用商業濾光片替(ti)代(dai)建議的(de)測試時，應使用一組覆蓋整個感興趣范圍的(de)濾光片。它們應可(ke)溯源至國(guo)家(jia) / 國(guo)際(ji)標準(zhun)進(jin)(jin)行(xing)校(xiao)準(zhun)，最好通過國(guo)家(jia)計量(liang)實驗室或(huo)美國(guo)國(guo)家(jia)標準(zhun)與技術研究院（NIST）進(jin)(jin)行(xing)。
2.Spectral Slit Width (if applicable)
光譜狹(xia)縫寬(kuan)度（如(ru)適用）
When using an instrument on which the slit - width is variable at the selected wavelength, the slit width must be small compared with the half - width of the absorption band but it must be as large as possible to obtain a high value of Ia. Therefore, a slit - width is chosen such that further reduction does not result in a change in absorbance reading.
當使用在選定波長(chang)下(xia)狹縫(feng)寬(kuan)(kuan)(kuan)度可變的儀(yi)器時(shi)，狹縫(feng)寬(kuan)(kuan)(kuan)度必須與(yu)吸(xi)收帶的半寬(kuan)(kuan)(kuan)度相比很小，但又必須盡(jin)可能大以獲得高的 Ia 值。因(yin)此，選擇的狹縫(feng)寬(kuan)(kuan)(kuan)度應使得進一步減小不會導致吸(xi)光度讀數的變化。
Method and Limits
方法和限度
1.Switch the system on and start the Scan module.
開啟(qi)系統(tong)并啟(qi)動掃(sao)描模(mo)塊。
2.Select SETUP and set the following parameters:
選擇(ze) “設(she)置” 并設(she)置以下參數(shu)：
X Mode = Nanometers
X 模式 = 納米
Start wavelength = 650.0 nm
起始波長 = 650.0 納米
Stop wavelength = 660.0 nm
終止波長 = 660.0 納米
Scan mode = Single
掃描模式 = 單次
Scan rate = 100 nm/min
掃描(miao)速率 = 100 納米 / 分鐘
Gain = (100) see 4 below
增益 = （100）見下面第 4 點
3.Select Options tab and set the following parameters:
選擇 “選項” 選項卡(ka)并設置以下參(can)數：
SWB = 4 nm
狹縫(feng)寬(kuan)度(du)帶寬(kuan) = 4 納(na)米(mi)
Scan mode = Single front
掃描模式 = 單次前(qian)向
Lamps on = Deuterium
燈開啟 = 氘燈
Source change = 700.0 nm
光源切(qie)換(huan) = 700.0 納米
4.Start a scan and examine the trace for a spectral peak around 656.1 nm. If no peak is seen or it is less than 50 % T, increase the gain.
開始(shi)掃描并檢查在 656.1 納米附(fu)近的光譜峰的軌跡。如(ru)果看不(bu)到峰或其小于(yu) 50% 透光度（T），則增加(jia)增益。
5.Measure the width of the peak (in nanometres) at half the height of the peak.
測(ce)量峰高一半處的峰寬（單位(wei)：納米）。
This represents the spectral bandwidth and should be within ± 10% of that selected via the computer.
這代表光譜帶寬，其值應(ying)在通過計(ji)算機(ji)選擇(ze)的值的 ±10% 范(fan)圍內。
6.Check the calibration at a slit width of 0.2 nm.
在狹縫(feng)寬度為(wei) 0.2 納米時(shi)檢(jian)查校(xiao)準情(qing)況。
If the measured slits are too small then, for a selected width, the instrument will have more photometric noise than normal.
如果測量的(de)狹縫過小，那么對于選(xuan)定的(de)寬度，儀器將產(chan)生(sheng)比正常情況更(geng)多的(de)光度噪聲(sheng)。
If the slit width is unacceptable, then reset the slit calibration.
如果狹縫寬度不可接受，則重(zhong)置狹縫校準。
EDQM發布《紫外-可見分光光度計確(que)認指南》
Effect of spectral slit width on absorbance fluctuation (performed with pure solvents).
光(guang)譜狹縫寬度(du)對吸光(guang)度(du)波(bo)動的(de)影(ying)響（使(shi)用(yong)純溶劑進行）。
EDQM發布(bu)《紫外(wai)-可見分光光度(du)計(ji)確認指(zhi)南》
3.Wavelength Precision (for mechanically set wavelengths)
3. 波長精度（針對機(ji)械設定波長）
Materials:
材料：
For this test, the same materials of the previous test can be used: Holmium perchlorate solution R prepared, for example, with a 40 g/L solution of holmium oxide R in a solution of perchloric acid R containing 141 g/L of HClO4 (Ph. Eur. Chapter 4.1.1. "Reagents", ref. 1043101).
對(dui)于此測(ce)試(shi)，可以使用與之前測(ce)試(shi)相同的(de)(de)材(cai)料：例如，將氧化鈥 R 的(de)(de) 40 g/L 溶液(ye)在(zai)含有(you) 141 g/L 高(gao)氯(lv)酸（HClO4）的(de)(de)高(gao)氯(lv)酸 R 溶液(ye)中制備的(de)(de)高(gao)氯(lv)酸鈥溶液(ye) R（歐洲藥典第 4.1.1 章 “試(shi)劑”，參考文(wen)獻 1043101）。
If available, the built - in mercury lamp of the instrument may be used for this test. Alternatively, suitable commercial certified filters may be used1.
如果有儀器內置(zhi)的(de)汞(gong)燈，可用于此(ci)測試(shi)。或者，也(ye)可使用合適的(de)商業認證濾光片 1。
Method:
方法：
Carry out 6 measurements of the absorbance maxima.
對(dui)吸光(guang)度最大值進行 6 次測量(liang)。
Limits:
限度：
Repeatability: the relative standard deviation of the absorbance maxima should satisfy the manufacturer's specifications.
重復性(xing)：吸光度最大值(zhi)的相(xiang)對標(biao)準偏(pian)差(cha)應(ying)符合制(zhi)造(zao)商的規(gui)格要求。
The difference between the 6 individual absorbance maxima values should comply with the manufacturer's specifications (e.g. < 0.5 nm).
6 個單獨的吸光度最大值之間的差(cha)值應符(fu)合制造商(shang)的規格要求(qiu)（例如 < 0.5 nm）。
4.Baseline Noise
基線噪聲
For this test, 2 alternative methods are proposed.
對于此測試，提出了兩種(zhong)替代方法。
TEST 1
測試 1
Method:
方法：
Make 61 absorbance measurements with an integration time of 1 second at a wavelength of 500 nm, with no sample in the sample chamber, and calculate the mean.
在 500 納米波(bo)長下，積分(fen)時間為 1 秒，在樣品室中無樣品的情況下進行 61 次吸光度測(ce)量，并計算平均值(zhi)。
Limits:
限度：
Mean ± 0.002 Absorbance units
平均值 ± 0.002 吸光(guang)度單(dan)位
TEST 2
測試 2
Method:
方法：
Record the absorbance for 60 seconds at 200, 300 and 400 nm with a highly pure, synthetic Quartz block¹. The measurement is made against air.
使(shi)用(yong)高(gao)純度(du)合成石英塊在 200、300 和 400 納米處記錄 60 秒的吸光度(du)。測量(liang)以(yi)空氣為(wei)參(can)比。
Note: If commercial filters are used, the wavelengths and the exact absorption values with the corresponding tolerance limits will depend on the type of filters.
注意：如果使用商用濾(lv)光(guang)片，波長以及確切的(de)吸收值(zhi)和相應(ying)的(de)容差(cha)限度(du)將(jiang)取決于濾(lv)光(guang)片的(de)類型。
Example of limits:
限度示例：
EDQM發(fa)布《紫(zi)外-可(ke)見分光光度計確認指(zhi)南》
Photometric Drift
光度漂移
Photometric drift should be checked at both the visible and UV region, at appropriate wavelengths. The limits are in accordance with the user's requirements (as defined in Level I) and with manufacturer's specifications.
光度漂移(yi)應在可見光和紫外光區域的(de)適(shi)當波長下進行檢查。其限(xian)度應符合用戶要求（如一級所定(ding)義）和制造商的(de)規格。
For this test, 2 alternative examples are proposed.
對于此(ci)測試，提出了兩個(ge)替代示例。
TEST 1
測試 1
Method:
方法：
As routine test, the drift is measured at 250 nm over a period of 2 hours by using the Time Scan mode of the instrument, with no sample in the sample chamber.
作為常規(gui)測(ce)試(shi)，在(zai)樣(yang)品室無樣(yang)品的(de)情(qing)況(kuang)下，使用儀器的(de)時(shi)間掃描模式(shi)在(zai) 250 納米(mi)波長下測(ce)量 2 小時(shi)內的(de)漂移。
Limits: ± 0.001 Absorbance units/h
限度(du)：±0.001 吸光度(du)單位 / 小(xiao)時
Note: In certain cases, for example when several samples are measured over a long period of time (or when using auto sampler), the drift can also be determined at the wavelength reported in the analytical method, under the same operational conditions, before testing samples.
注意：在(zai)某些(xie)情況(kuang)下(xia)，例如(ru)在(zai)長(chang)時間測量多(duo)個樣品時（或使用自動進(jin)樣器時），也可(ke)以在(zai)測試樣品之前，在(zai)相同操作條件(jian)下(xia)，在(zai)分析方法中報告的波長(chang)處測定漂移。
TEST 2
測試 2
Method.
方法
Record the baseline for 60 minutes at 500 nm and compare the absorbance with the initial value.
在 500 納(na)米(mi)處記錄 60 分鐘基線，并將吸光度與初始值進行比較。
Limits: ± 0.002 Absorbance units/h
限(xian)度：±0.002 吸(xi)光度單位 / 小時
Level IV. In - use instrument checks
IV 級 使用中(zhong)儀器檢查(cha)
This Annex contains practical examples of tests and their associated acceptance limits for several parameters related to the performance of an UV - Visible spectrophotometer. These examples can be considered by the OMCLs as possible approaches to perform the Level IV of the equipment qualification process: “In - use instrument checks”.
本附錄包含了與紫外 - 可(ke)見分光光度計性能相關的(de)(de)幾個參(can)數的(de)(de)測試實(shi)例及(ji)其(qi)相關的(de)(de)可(ke)接受限度。這些實(shi)例可(ke)被官(guan)方藥品控制實(shi)驗室（OMCLs）視為執行(xing)(xing)設備確認過程 IV 級 “使用中儀器檢查” 的(de)(de)可(ke)行(xing)(xing)方法(fa)。
SYSTEM SUITABILITY TEST OF THE METHOD
方(fang)法的系(xi)統適用性測試
REPEATABILITY (for quantitative analysis)
重(zhong)復性(xing)（用于定(ding)量分(fen)析）
RESOLUTION (for both qualitative and quantitative analysis)
分辨(bian)率（用于定性和定量分析）
Method:
方法：
This test should be performed according to Ph. Eur., the MAH dossier or a suitably validated in - house method.
此(ci)測試(shi)應根據《歐洲藥典》、上市許可持(chi)有人（MAH）檔案或(huo)經過適當驗(yan)證的內部(bu)方法(fa)進行(xing)。
本文由(you)廣州佳(jia)譽(yu)醫療器(qi)(qi)械有(you)限(xian)公司/佛山浩(hao)揚醫療器(qi)(qi)械有(you)限(xian)公司聯(lian)合編輯
