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lingyunxn金虫 (正式写手)
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7.3 Development of trace analytical methods for residual impurities A trace analytical method may have to be developed for the determination of the RI in the last rinsate and / or in the succeeding product. The preceding client should be consulted to find out whether they can provide any information on analytical methods for the determination of trace levels of the preceding active ingredients. However, it should be realized that methods are specific to analytical equipment. In practice, quality control or residue analytical methods are often adapted for RI trace analysis: Thin layer chromatography (TLC) is a simple and cheap, semi-quantitative analytical method suitable for the RI analysis in the succeeding product. However, its use is often limited to changeovers with detection limits above 100 ppm and RIs that absorb UV light for detection. Gas (GC) and Liquid Chromatography (LC) are applied for RI analysis in the succeeding product or in the rinsate when low cleaning levels have to be confirmed. LC-MS, GC-MS or other mass spec.-chromatographic methods are suitable for very low cleaning levels (<< 50 ppm). GC and LC trace analytical methods must be validated for linearity and recovery in the target cleaning level range: o A suitable, validated cleaning procedure should give a cleaning result X, which is equal or below the target cleaning level. The target cleaning level is calculated by multiplying the cleaning level (as listed in the RI matrix) with a safety factor to account for possible analytical variability (Fig. 10 shows an example for a cleaning level of 100 ppm and a safety factor of 0.66). o It is recommended that the limit of quantification relevant to this discussion should equal 40% of the cleaning level. This limit is not to be confused with the lower limit of detection of the analytical method. |
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3楼2010-06-29 11:01:11
noleg
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wypward(金币+1):谢谢参与 2010-06-26 22:26:57
lingyunxn(金币+10, 翻译EPI+1): 2010-06-30 01:09:07
发芽土豆(金币+15):代发金币 2010-07-03 14:10:46
wypward(金币+1):谢谢参与 2010-06-26 22:26:57
lingyunxn(金币+10, 翻译EPI+1): 2010-06-30 01:09:07
发芽土豆(金币+15):代发金币 2010-07-03 14:10:46
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7.3 残余杂质的追踪分析分析方法的建立 可能需要建立一种追踪分析方法以检测最后冲洗剂和/或者后续生产产品中的残余杂质（译注——RI=residual impurities）。应该建议上一个产品的客户弄清楚是否能提供有关上一个产品中所含痕量活性成分的检测方法上任何信息。但是，应该认识到(测定)方法针对于特定的仪器。 实际上，质量控制或残余分析方法常常应用于RI的痕量分析： 薄层色谱(TLC)是适用于后续产品中RI分析的简单、便宜、半定量分析方法。但是它的使用常常仅限于检测极限值高于100ppm的转换或者RI能吸收检测紫外光。 气相色谱(GC)或液相色谱(LC)适合于后续产品的RI分析或者当清洁程度要求较低时的冲洗剂的分析。 液质(LC-MS)、气质(GC-MS)或其它质谱-色谱联用方法适用于很低的清洁水平(<<50ppm)。 GC和LC痕量分析方法必须验证其在目标清洁水平范围内的线性和再现性： o 一种适用的、有效的清洗程序必须给出一个清洁结果X，该值等于或低于目标清洁水平。目标清洁水平的计算方法是将清洁水平(列于RI阵列)乘以一个考虑到可能的分析变异的安全因子(图10中的例子表示清洁水平为100ppm，其安全因子为0.66)。 o 建议与此处的讨论有关的定量极限值应等于清洁水平的40%。该极限值不要与比它更低的分析方法的测定值的极限值相混淆。 |
2楼2010-06-26 21:36:05