求购“Choline([11C]methyl)injection”《EP9.4》的药典信息一份.
- 发布需求
- 药智客交稿
- 任务主选稿中
- 验收与付款
- 交易模式：
- 单人中标
- 赏金分配：
- 一人独享赏金，￥42.5
-
匿名
Updated Ph. Eur. 9.4, effective 01/04/2018 Choline ([11C]Methyl) Injection General Notices (Ph. Eur. monograph 2462) 11C1C4H14NO+ 103.2 94793-58-5 Ph Eur DEFINITION Sterile solution containing 2-hydroxy-N-[11C]methyl-N,N-dimethylethan-1-aminium ([methyl-11C]choline) ions. It may contain a suitable buffer. Content — carbon-11: 90 per cent to 110 per cent of the declared carbon-11 radioactivity at the date and time stated on the label. CHARACTERS Appearance Clear, colourless solution. Half-life and nature of radiation of carbon-11 See general chapter 5.7. Table of physical characteristics of radionuclides. IDENTIFICATION A. Gamma-ray spectrometry. Result The principal gamma photons have an energy of 0.511 MeV and, depending on the measurement geometry, a sum peak of 1.022 MeV may be observed. B. Approximate half-life: 19.0 min to 21.8 min. C. Examine the chromatograms obtained with reference solution (d) in the test for [methyl-11C]choline under Radiochemical purity (see Tests). Result The principal peak in the radiochromatogram is similar in retention time to the principal positive peak in the chromatogram obtained with the spectrophotometer. TESTS pH (2.2.4) 4.5 to 8.5. Impurity A Gas chromatography (2.2.28). Test solution The preparation to be examined. Reference solution (a) Dissolve 10.0 mg of dimethylaminoethanol R (impurity A) in water R and dilute to 10.0 mL with the same solvent. Dilute 1.0 mL of the solution to V with water R, V being the maximum recommended dose in millilitres. Reference solution (b) To 0.1 mL of ethanol R add 0.1 mL of acetonitrile R and dilute to 10 mL with water R. Column: — material: fused silica; — size: l = 30 m, Ø = 0.32 mm; — stationary phase: poly[(cyanopropyl)(phenyl)][dimethyl]siloxane R (film thickness 1.8 µm). Carrier gasnitrogen for chromatography R. Flow rate 1.5 mL/min. Split ratio 1:10. Temperature: Detection Flame ionisation. Injection 1.0 µL. System suitability: reference solution (b): — resolution: minimum 2.0 between the peaks due to ethanol and acetonitrile. Calculation of content: — for impurity A, use the concentration of impurity A in reference solution (a). Limit: — impurity A: maximum 1.0 mg/V. Residual solvents Limited according to the principles defined in general chapter 5.4. The preparation may be released for use before completion of the test. Sterility It complies with the test for sterility prescribed in the monograph Radiopharmaceutical preparations (0125). The preparation may be released for use before completion of the test. Bacterial endotoxins (2.6.14) Less than 175/V IU/ mL, V being the maximum recommended dose in millilitres. The preparation may be released for use before completion of the test. RADIONUCLIDIC PURITY The preparation may be released for use before completion of test B. Carbon-11 Minimum 99.9 per cent of the total radioactivity. A. Gamma-ray spectrometry. Limits Peaks in the gamma spectrum corresponding to photons with an energy different from 0.511 MeV or 1.022 MeV represent not more than 0.1 per cent of the total radioactivity. B. Gamma-ray spectrometry. Determine the amount of carbon-11 and radionuclidic impurities with a half-life longer than 20 min. For the detection and quantification of impurities, retain the preparation to be examined for at least 3 h to allow the carbon-11 to decay to a level that permits the detection of impurities. Result The total radioactivity due to radionuclidic impurities is not more than 0.1 per cent. RADIOCHEMICAL PURITY [Methyl-11C]choline Liquid chromatography (2.2.29). Test solution The preparation to be examined. Reference solution (a) Dissolve 5 mg of choline chloride R in water R and dilute to 20 mL with the same solvent. Reference solution (b) Dissolve 5 mg of fluorocholine chloride R in water R and dilute to 20 mL with the same solvent. Reference solution (c) Mix 1 mL of reference solution (a) and 1 mL of reference solution (b). Reference solution (d) Mix 1 mL of the test solution and 1 mL of reference solution (a). Column: — size: l = 0.25 m, Ø = 4.6 mm; — stationary phase: cation-exchange resin R2 (5 µm). Mobile phase Dissolve 20.7 g of sodium dihydrogen phosphate monohydrate R in water for chromatography R and add 80 µL of anhydrous pyridine R. Adjust to pH 2.5 with phosphoric acid R and dilute to 1 L with water for chromatography R. Flow rate 1.5 mL/min. Detection Spectrophotometer at 270 nm and radioactivity detector connected in series. Injection 20 µL of the test solution and reference solutions (c) and (d). Run time 14 min. Relative retention With reference to choline: fluorocholine = about 0.9. System suitability Reference solution (c) using the spectrophotometer: — resolution: baseline separation between the peaks due to fluorocholine and choline. Examine the radiochromatogram obtained with the test solution. Limit: — [methyl-11C]choline: minimum 95 per cent of the total radioactivity due to carbon-11. RADIOACTIVITY Determine the radioactivity using a calibrated instrument. IMPURITIES A. 2-(dimethylamino)ethan-1-ol, B. iodo[11C]methane. Ph Eur
数据载入中....发言请遵守"七条底线"，还可以输入140个字 -
匿名
见附件，请查收！
㖌附件：PDF Choline([11C]methyl)injection.pdf发言请遵守"七条底线"，还可以输入140个字 -
-
匿名
查收
㖌附件：PDF Choline ([11C]methyl) injection-EP9.4.pdf数据载入中....发言请遵守"七条底线"，还可以输入140个字
当前为付费需求，赏金分配方式：一人独享赏金。
任务主在众多备选稿件中选择最满意的稿件，支付赏金。
托管赏金，保障各方权益：
任务主把所发需求的悬赏金托管到药智网指定账户，以激发众多药智客的参与热情，保障任务主尽快征集到满意稿件；
同时，赏金托管也是为了保障参与挑战的药智客的正当权益。
流程说明：
点击“发布需求”按钮，按照流程引导，将需求详情、具体要求描述清楚，发布到药智网的药智汇平台。
为征集到满意稿件，任务主须做好“赏金预算”，并将赏金托管到药智网指定账户，打消药智客的顾虑，激励药智客积极参与需求挑战。
任务主托管赏金后，所发布的需求显示“赏金已托管”字样。只有托管了悬赏金的需求，能够鼓舞众多的药智客参与，获取到满意的稿件！
任务主在众多参与者提交的稿件中，选择符合任务主需求的稿件。再通过互动，选择任务主最满意的稿件，并确定其为中标稿件。
中标稿件提交任务主验收。任务主在验收/验证期内，完成验收/验证工作。对合格稿件，通知药智网支付佣金。
双方可以针对本次交易各自的表现进行评价，评价结果将影响各自的信用度和能力值。
类似的需求
该需求者还有这些需求
