EP问答31-40

julia朱玉姣

31. The monograph does notinclude chemical reference substances or relative retentions for specifiedimpurities. 各论并未包括特定杂质的化学对照物质或相对保留时间。

This monograph might be part of our revision programmeto introduce chemical reference substances for peak identification and relativeretentions for specified impurities as well as an explicit acceptance criterionfor unspecified impurities. Please contact us if you can submit furtherinformation.

此各论可能是我们修订计划的一部分。我们将会进行修订引入化学对照物质用于峰鉴别，以及确定特定杂质的相对保留时间，并为非特定杂质制订清楚的可接受标准。如果你能够提交更多资料，请与我们联系。

32. What is the differencebetween a peak area comparison and a quantitative limit for relatedsubstances?  相关物质峰面积比较和定量限度有什么区别？

In the past, the acceptance criteria for relatedsubstances were expressed relative to the area of a reference peak of knownconcentration (limit test). Without providing a numerical result, thecomparison of peak areas leads to a pass/fail decision. For comparative tests,the approximate content of impurity tolerated, or the sum of impurities, isindicated in brackets for information only. In most cases, current monographsdescribe quantitative determinations: a calculation of the content is necessaryto establish compliance with the monograph.

在过去，有关物质的可接受标准表述为与已知浓度（限度测试）的对照峰面积进行比较的结果。由于不能提供数值式结果，峰面积比较只能得到合格/不合格的结果。在对比测试中，允许的大致杂质含量，或者是杂质合计，在括号里给出仅供参考。在大多数情形下，目前的各论描述的是定量检测，需要对含量进行计算以确定是否符合各论要求。

33. In the case of aharmonised monograph, is it possible to use a reference standard from adifferent pharmacopoeia? 如果各论是协调过的，是否有可能使用不同药典的对照标准？

No. The use of a European Pharmacopoeia monographrequires the use of European Pharmacopoeia reference standards that arereviewed and approved by the European Pharmacopoeia Commission.

不可以。使用EP各论就要求使用经过EP委员会审核和批准的EP对照品。

34. Is it possible to performa type of measurement (such as ATR) different from that described in themonograph? 是否可能实施与各论不同的检测（例如ATR）？

In principle, you can choose one of the methodsdescribed in chapter 2.2.24, unless the monograph prescribes a comparison witha reference spectrum or an explicit preparation. Alternatively,cross-validation with the monograph method is required. In any case, you haveto apply the same procedures for the substance to be examined and the referencestandard, under the same conditions.

原则上来说，你可以选择2.2.24章里的一种方法，除非各论描述了与对照图谱比较，或者清楚说明了制备方法。否则，需要与各论进行交叉验证。不管如何，你必须对待测物质在相同的条件下使用相同的程序和标准。

35. Do I have to perform allthe tests described in the Identification section of a monograph? 我是否必须做各论中鉴别部分所述的所有鉴别测试？

No, the test or tests that constitute the ‘Firstidentification’ may be used in all circumstances. The second identificationseries is not intended for use in any other context than pharmacies. It may beused only if it can be demonstrated that the substance or preparation is fullytraceable to a batch certified to comply with all the other requirements of themonograph.

不需要。在所有情形下，都可以只做“第一鉴别”中所包括的测试。第二鉴别系列是为了药房设计的，其它情况下不需要做。如果可以证明物制或制剂可以追踪至经过认证符合各论所有其它要求的批次，它才会被使用。

36. I have trouble meeting thecriteria under “Characters”. 我没法符合“性状项”下的标准。

The statements under the heading Characters are not tobe interpreted in a strict sense and are not requirements. It is therefore notmandatory to verify compliance with the Characters section for batch release.

在“性状”项下的声明并不是严格诠释的，也不是要求。因此，在批放行时并不强制要求确认与性状部分的要求相符合。

37 Which is the differencebetween “dried” and “anhydrous” substance? “干燥”和“无水”物质之间有什么区别？

“Dried substance” takes into account the loss ondrying test (including class 3 solvents), whereas “anhydrous substance” refersto the result obtained by the water determination. It is important to note thatwhen a quantitative determination of a residual solvent is carried out and atest for loss on drying is not carried out, the content of residual solvent istaken into account for the calculation of the assay content of the substance,the specific optical rotation and the specific absorbance, even if notexplicitly stated in the definition.

“干品”考虑的是干燥失重测试（包括3类溶液），而“无水物”指的是通过水分检测得到的结果。重要的一点是需要注意，当对物质的残留溶剂进行定量测定，并且没有测定LOD时，物质含量、比旋、吸光的计算中要考虑残留溶剂的含量，即使在定义没有清楚说明，也是要考虑的。

38 The definition of substanceX gives the content on dried or anhydrous basis. What about the solvents, arethey to be taken into account when determining the assay? 物质X的定义中说含量是以干品计或以无水物计。那溶剂呢，在计算含量时也要考虑吗？

In accordance with the general monograph Substancesfor pharmaceutical use (2034), the content of residual solvents is taken intoaccount for calculation of the assay content of the substance, the specificoptical rotation and the specific absorbance. This information is therefore notindicated in the specific monographs concerned.

根据药用物质通论（2034），在计算物质含量、比旋和吸光时要考虑残留溶剂的含量。因此，在各论中并没有特意说明此要求。

继续发

39. What precision is requiredfor weighing or measuring? 称重和测量时，要求的精确度是怎样的？

In tests with numerical limits and assays, thequantity stated to be taken for examination is approximate. The amount actuallyused, which may deviate by not more than 10 per cent from that stated, isaccurately weighed or measured and the result is calculated from this exactquantity.

在数值限度和含量测试中，检测用数量为大约。实际所用的数量可以与所要求的数量差异10%以内，要准确称重或测量，结果要采用确切的数量来计算。

In tests where the limit is not numerical, but usuallybased on comparison with the behaviour of a reference substance under the sameconditions, the stated quantity is taken for examination.

在非数值式限度测试中，通常是基于与对照物质在相同条件下相比较的情形下，则应取用所指明的检测用数量。

Reagents are used in the prescribed amounts.

所用的试剂应按所述数量取用。

For weighing, the precision corresponds to plus orminus 5 units after the last figure stated (for example, 0.25 g is to beinterpreted as 0.245 g to 0.255 g).

如果是称重，应称取指定数值的最后一位之后±5个单位（例如，0.25g应称量0.245g-0.255g）的重量。

For weighing, the precision corresponds to plus orminus 5 units after the last figure stated (for example, 0.25 g is to beinterpreted as 0.245 g to 0.255 g).

40. Am I allowed to round offmeasurements? 是否允许修约结果？

In determining compliance with a numerical limit, thecalculated result of a test or assay is first rounded off to the number ofsignificant figures stated, unless otherwise prescribed. The limits, regardlessof whether the values are expressed as percentages or as absolute values, are consideredsignificant to the last digit shown (for example, 140 indicates 3 significantfigures). The last figure of the result is increased by one when the partrejected is equal to or exceeds one half-unit, whereas it is not modified whenthe part rejected is less than a half-unit.

在确定数值式限度是否符合标准之前，测试或含量计算所得结果应先修约至所要求的有效数值，另有说明者除外。限度值，不管是否表达为百分比还是绝对数值，都认为其所显示的最后一位是有效的（例如，140为3位有效数值）。当被修约的位数字等于或大于一半单位时，结果的最后一位数加1，当被修约的数字位小于一半单位时，结果的最后一位数不变。

xhf123456

学习一下

joysun611

有机会的时候来听听学习学习哦！

syhorchid

结集打包吧

julia朱玉姣

syhorchid 发表于 2016-7-5 00:25
结集打包吧

最后一集中已打包好，直接下载即可

清风化雨

多谢分享!