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新聞中心
EDQM發布《紫外-可見分光光度計確認指南》
近日，EDQM-OMCL發布《紫外(wai)(wai) - 可(ke)見(jian)分光(guang)(guang)光(guang)(guang)度(du)計確(que)認指南》，包含Level III定期(qi)及(ji)有動機(ji)的(de)儀器檢查(cha)、紫外(wai)(wai) - 可(ke)見(jian)分光(guang)(guang)光(guang)(guang)度(du)計的(de)建議(yi)及(ji)相關典型接受限、Level IV在用儀器檢查(cha)、一般注意事項、光(guang)(guang)譜狹(xia)縫寬(kuan)度(du)（如(ru)適用）、波(bo)長精度(du)、基(ji)線噪(zao)聲、光(guang)(guang)度(du)漂移等(deng)內容。文件將于9月(yue)1日生效。
ANNEX 3 OF THE OMCL NETWORK GUIDELINE “QUALIFICATION OF EQUIPMENT”
OMCL設備(bei)確認指南附錄(lu)3
QUALIFICATION OF UV - VISIBLE SPECTROPHOTOMETERS
紫外(wai)-可見分(fen)光(guang)(guang)光(guang)(guang)度計的確認
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：本附件(jian)中的強制性要求使(shi)用 “應” 或 “必須(xu)” 等詞來定義。“宜(yi)” 的使(shi)用表示(shi)一(yi)(yi)(yi)種建議。對于(yu)文本的這些部分(fen)，其他有適(shi)當理由的方法是(shi)可(ke)接受(shou)的。“可(ke)” 一(yi)(yi)(yi)詞表示(shi)一(yi)(yi)(yi)種可(ke)能(neng)性或一(yi)(yi)(yi)個(ge)不具(ju)約(yue)束(shu)力的示(shi)例(li)。
Table of Contents
目錄
Introduction
簡介
Level III. Periodic and motivated instrument checks
三(san)級：定期及(ji)有動機的儀(yi)器檢查
Recommendations for UV - visible spectrophotometers and related typical acceptance limits
紫外(wai) - 可見(jian)分光光度計的建議及相關典型(xing)接受限
Level IV. In - use instrument checks
四級：使用(yong)中儀(yi)器檢查
Recommendations for UV - visible spectrophotometers and related typical acceptance limits
紫外 - 可見分(fen)光(guang)光(guang)度計的(de)建議及相關(guan)典型接受(shou)限
Level III. Periodic and motivated instrument checks
三級：定期及有動機的儀器檢查
General Considerations
一般注意事項
Spectral Slit Width (if applicable)
光(guang)譜(pu)狹(xia)縫寬度（如適用）
Wavelength Precision (for mechanically set wavelengths)
波(bo)長(chang)精度（對于機械設定波(bo)長(chang)）
Baseline Noise
基線噪聲
Photometric Drift
光度漂移
Level IV. In - use instrument checks
四級：使用中儀器檢查(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(ben)文(wen)件(jian)(jian)是核(he)心(xin)(xin)文(wen)件(jian)(jian) “設備確(que)認” 的第(di) 3 個附件(jian)(jian)，在規劃、執行和記(ji)錄紫外 - 可見分光光度計確(que)認過(guo)程(cheng)時(shi)，應與該核(he)心(xin)(xin)文(wen)件(jian)(jian)結(jie)合使用。
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(he)心文件包含一(yi)級（儀(yi)器和(he)供應(ying)商的選擇）和(he)二(er)級（安裝和(he)投入使用(yong)）確認的簡介和(he)通(tong)用(yong)表(biao)格，這些適用(yong)于所有類型的儀(yi)器。
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(bao)含(han)紫外 - 可見(jian)分光(guang)光(guang)度計的(de)簡介(jie)和(he)要(yao)(yao)求(qiu)(qiu)。三級(ji)（定(ding)期(qi)及有動機的(de)儀器校準(zhun) / 檢(jian)查）和(he)四級(ji)（使用中儀器檢(jian)查）確認必須按照 ISO/IEC 17025 要(yao)(yao)求(qiu)(qiu)進行。
Requirements (if applicable) corresponding typical acceptance limits given in bold should be applied; however other appropriately justified approaches are acceptable.
應采(cai)用(yong)（如適(shi)用(yong)）以粗體給出的相應典型(xing)接(jie)受限；然而(er)，其他有適(shi)當(dang)理由的方法也(ye)是可接(jie)受的。
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(jian)中提供(gong)的示例程(cheng)序不具約束力。它們可能有助(zhu)于(yu)進(jin)行(xing)所需的確(que)認。然而(er)，由(you)每個 OMCL 根(gen)據專業判(pan)斷和背(bei)景經驗(yan)來(lai)決定采用最相關的程(cheng)序，以證明其(qi)紫外 - 可見分光光度(du)計工作正常且適合其(qi)預期(qi)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(de)確認是由制造商或外部服(fu)務(wu)提供商完(wan)成的(de)，那么 OMCL 有責任確保(bao)其符合本指(zhi)南中(zhong)規(gui)定的(de)要(yao)求。
Level III. Periodic and motivated instrument checks
三級 定期及(ji)有(you)動機的儀器檢查(cha)
recommendations for UV - visible spectrometers and related typical acceptance limits
對紫外(wai) - 可見分光(guang)(guang)光(guang)(guang)度(du)計的建議及相關典(dian)型接受限度(du)
EDQM發布《紫外-可見分光光度(du)計確認指南》
following the instructions given in Ph. Eur. Chapter 2.2.25. "Control of equipment performance"
遵(zun)循《歐洲(zhou)藥典》第 2.2.25 章 “設備(bei)性能控制” 中給出的說明(ming)
Level IV. In - use instrument checks
四級 使用中(zhong)儀器的檢查
Recommendations for UV - visible spectrophotometers and related typical acceptance limits
紫外 - 可(ke)見分光光度(du)計的建議(yi)以及相關典型的可(ke)接(jie)受限度(du)
EDQM發布《紫外-可(ke)見分(fen)光光度計確認指南》
following the instructions given in Ph. Eur. Chapter 2.2.25. "Control of cuvettes"
按照歐洲藥典第 2.2.25 章 “比(bi)色皿的控(kong)制” 中給出的說明操(cao)作
Level III. Periodic and motivated instrument checks
第三(san)級(ji)：定期及有動機的(de)儀器檢(jian)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(jie)包含了(le)與紫外(wai) - 可(ke)(ke)見分光光度(du)計性能(neng)相關的(de)(de)(de)幾個(ge)參數的(de)(de)(de)測試實例(li)及其相關的(de)(de)(de)合格限。這些實例(li)可(ke)(ke)被視為執行設備確認(ren)過(guo)程第(di)三級 “定期(qi)及有動機的(de)(de)(de)儀器檢查(cha)” 的(de)(de)(de)可(ke)(ke)能(neng)方法(fa)（即操作規(gui)范(fan)條(tiao)件(jian)）。
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.
通過將樣(yang)品與外部標(biao)準進(jin)行(xing)(xing)比較而(er)進(jin)行(xing)(xing)的測量(liang)應(ying)在(zai)溫度保持恒(heng)定(ding)的條件下進(jin)行(xing)(xing)。這在(zai)載(zai)液為有機(ji)溶(rong)劑且(qie)測量(liang)可(ke)能因溶(rong)劑的膨脹或蒸發而(er)失真的情況下尤(you)為重要。
It is recommended to perform the qualification within the spectral range corresponding to the region of analytical interest.
建(jian)議(yi)在與分析感興趣區域相對應的(de)光譜范(fan)圍內(nei)進行確認。
Ensure that the spectrophotometer has stabilised, according to the manufacturer's recommendations, before starting the qualification tests.
根(gen)據制(zhi)造商(shang)的(de)建議，在開始確認測試之前，確保分光光度(du)計已穩(wen)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(dang)引用《歐(ou)洲(zhou)藥典》時，例(li)如試劑(ji) R，那(nei)么試劑(ji)質量應符合《歐(ou)洲(zhou)藥典》的規范(fan)。
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(yong)(yong)商業(ye)濾(lv)光片替代建(jian)議的(de)測試時，應使用(yong)(yong)一組覆蓋整個(ge)感興趣范(fan)圍的(de)濾(lv)光片。它(ta)們應可溯源至國家 / 國際標(biao)準(zhun)進行校準(zhun)，最(zui)好通過國家計量實驗室(shi)或美國國家標(biao)準(zhun)與技術研究(jiu)院（NIST）進行。
2.Spectral Slit Width (if applicable)
光譜(pu)狹縫寬(kuan)度（如適用(yong)）
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(shi)用在選定(ding)波長下狹(xia)縫寬度(du)可變的儀器時，狹(xia)縫寬度(du)必須(xu)與吸收帶(dai)的半寬度(du)相比很(hen)小(xiao)(xiao)，但又必須(xu)盡可能大以獲得高的 Ia 值。因(yin)此(ci)，選擇的狹(xia)縫寬度(du)應使(shi)得進一步(bu)減小(xiao)(xiao)不會導致吸光度(du)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(xi)統并啟(qi)動掃(sao)描(miao)模塊。
2.Select SETUP and set the following parameters:
選擇(ze) “設(she)置(zhi)” 并(bing)設(she)置(zhi)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(mi)
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
掃描速率 = 100 納米 / 分鐘
Gain = (100) see 4 below
增(zeng)益 = （100）見下面第 4 點
3.Select Options tab and set the following parameters:
選(xuan)擇 “選(xuan)項” 選(xuan)項卡(ka)并設置以下參數：
SWB = 4 nm
狹縫寬(kuan)度帶寬(kuan) = 4 納米
Scan mode = Single front
掃描模式 = 單次(ci)前向
Lamps on = Deuterium
燈開啟 = 氘燈
Source change = 700.0 nm
光源切換 = 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.
開始掃(sao)描并(bing)檢查(cha)在 656.1 納米附近的(de)光(guang)譜(pu)峰(feng)的(de)軌跡(ji)。如果看不到峰(feng)或(huo)其小于 50% 透光(guang)度（T），則增加增益。
5.Measure the width of the peak (in nanometres) at half the height of the peak.
測量峰(feng)高一半處(chu)的峰(feng)寬（單位：納米）。
This represents the spectral bandwidth and should be within ± 10% of that selected via the computer.
這(zhe)代表光譜帶寬，其(qi)值應在(zai)通過計算機選擇的值的 ±10% 范圍內。
6.Check the calibration at a slit width of 0.2 nm.
在狹縫(feng)寬度為 0.2 納米(mi)時檢查(cha)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)(de)狹(xia)縫過(guo)小，那么對于選定的(de)(de)寬度，儀(yi)器將產生比正常情(qing)況更多的(de)(de)光度噪聲(sheng)。
If the slit width is unacceptable, then reset the slit calibration.
如果狹縫(feng)寬度不可接受(shou)，則重置狹縫(feng)校準。
EDQM發布《紫外-可見(jian)分光光度計確(que)認指南》
Effect of spectral slit width on absorbance fluctuation (performed with pure solvents).
光(guang)(guang)譜(pu)狹縫寬度對吸光(guang)(guang)度波(bo)動的影響(xiang)（使用(yong)純溶劑(ji)進行(xing)）。
EDQM發布《紫外-可見分(fen)光光度(du)計確認指南》
3.Wavelength Precision (for mechanically set wavelengths)
3. 波長(chang)精度(du)（針對機械設定波長(chang)）
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).
對于此測(ce)試，可以(yi)使用與(yu)之(zhi)前(qian)測(ce)試相同的(de)材料(liao)：例如，將氧(yang)化鈥 R 的(de) 40 g/L 溶(rong)液(ye)在含(han)有 141 g/L 高(gao)(gao)氯(lv)酸(suan)（HClO4）的(de)高(gao)(gao)氯(lv)酸(suan) R 溶(rong)液(ye)中制備的(de)高(gao)(gao)氯(lv)酸(suan)鈥溶(rong)液(ye) R（歐洲藥典第 4.1.1 章 “試劑”，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.
如果有儀器內置的(de)汞燈，可用于此測試。或者，也(ye)可使用合(he)適的(de)商業認證濾光(guang)片 1。
Method:
方法：
Carry out 6 measurements of the absorbance maxima.
對吸光度最大(da)值進行(xing) 6 次(ci)測量。
Limits:
限度：
Repeatability: the relative standard deviation of the absorbance maxima should satisfy the manufacturer's specifications.
重復性(xing)：吸光(guang)度(du)最大(da)值的(de)相對標準偏差應符合(he)制(zhi)造商(shang)的(de)規格要(yao)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(zhi)之間的差值(zhi)應符合制(zhi)造商的規格要求（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(shi)，提出(chu)了(le)兩(liang)種替(ti)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(zai) 500 納米波(bo)長下，積分(fen)時間為 1 秒(miao)，在(zai)樣品室中無樣品的情況(kuang)下進行 61 次吸光度(du)測(ce)量，并計算平(ping)均值。
Limits:
限度：
Mean ± 0.002 Absorbance units
平均值 ± 0.002 吸光度單位
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.
使用高純度(du)合成石英塊在(zai) 200、300 和 400 納米處記錄(lu) 60 秒的吸光度(du)。測(ce)量以空氣(qi)為(wei)參比。
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(shi)用商(shang)用濾光片(pian)，波長(chang)以及確切的(de)吸收值和相應的(de)容差限度(du)將取決于(yu)濾光片(pian)的(de)類(lei)型。
Example of limits:
限度示例：
EDQM發(fa)布《紫外-可見分光光度計確(que)認指南》
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.
光度漂移應在可見光和(he)紫外光區域的(de)適當波長下進行檢查。其限(xian)度應符合(he)用戶(hu)要(yao)求(qiu)（如一(yi)級所定義）和(he)制造商的(de)規(gui)格。
For this test, 2 alternative examples are proposed.
對于(yu)此測試(shi)，提出了兩個(ge)替代(dai)示(shi)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.
作為常規測試，在樣品(pin)室無(wu)樣品(pin)的(de)情(qing)況下(xia)，使用儀器的(de)時(shi)間掃描模式在 250 納米波長下(xia)測量 2 小時(shi)內(nei)的(de)漂移(yi)。
Limits: ± 0.001 Absorbance units/h
限(xian)度(du)：±0.001 吸光(guang)度(du)單位 / 小時
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)(zai)某些(xie)情況下(xia)，例(li)如在(zai)(zai)長時(shi)間測量多個樣(yang)品時(shi)（或使用自動(dong)進樣(yang)器時(shi)），也可以在(zai)(zai)測試樣(yang)品之前，在(zai)(zai)相同操作條件下(xia)，在(zai)(zai)分析方(fang)法中報告的(de)波長處(chu)測定(ding)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 納米(mi)處記錄 60 分鐘基(ji)線，并將吸光度與初(chu)始值進(jin)行比較(jiao)。
Limits: ± 0.002 Absorbance units/h
限度(du)：±0.002 吸光度(du)單位 / 小時
Level IV. In - use instrument checks
IV 級 使用中儀器檢查(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(lu)包含(han)了與紫外 - 可見(jian)分光光度計性能(neng)相關的(de)幾個參數(shu)的(de)測試(shi)實(shi)例及(ji)其(qi)相關的(de)可接受(shou)限度。這些實(shi)例可被官方(fang)藥品控制實(shi)驗(yan)室（OMCLs）視為執行設(she)備(bei)確認過程 IV 級(ji) “使用中儀(yi)器檢查” 的(de)可行方(fang)法。
SYSTEM SUITABILITY TEST OF THE METHOD
方(fang)法的(de)系統適用(yong)性測試
REPEATABILITY (for quantitative analysis)
重復性（用(yong)于(yu)定量分析）
RESOLUTION (for both qualitative and quantitative analysis)
分辨率（用于(yu)定性和定量分析(xi)）
Method:
方法：
This test should be performed according to Ph. Eur., the MAH dossier or a suitably validated in - house method.
此測試應根(gen)據《歐洲藥(yao)典(dian)》、上市(shi)許可持有人（MAH）檔(dang)案或經(jing)過適當驗證的(de)內部方法進行。
本文由廣州佳(jia)譽醫療器(qi)(qi)械(xie)有限公司(si)/佛山浩揚醫療器(qi)(qi)械(xie)有限公司(si)聯合編輯
