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  • yezi01

    第22楼2012/07/29

    Turbidimetry
    The optical property expressed as turbidity is the interaction between light and suspended particles in liquid. This is an expression of the optical property that causes light to be scattered and absorbed rather than transmitted in a straight line through the sample. The quantity of solid material in suspension can be determined by the measurement of the transmitted light. A linear relationship between turbidity and concentration is obtained when the particle sizes are uniform and homogeneous in the suspension. This is true only in very dilute suspensions containing small particles. Linearity between turbidity and concentration must be established by constructing a calibration curve using at least 4 concentrations.
    透射浊度法在液体中悬浊粒子和光之间存在相关性,这一光学特性表示为浊度。表示的是光在直线方向上发生的散射和吸收,而不是光直线通过样品的透射光学特性,通过测量透射光来测定混悬液中固体物质的量。当混悬液中粒子的大小均一且性质相同,可获得浊度和浓度之间的线性关系。仅仅在很稀的含有少量粒子的混悬液中,才可实现线性。必须使用至少4个浓度构建标准曲线来证明浊度和浓度间呈线性。

    Ratio Turbidimetry
    In ratio turbidimetry the relationship of the transmission measurement to the 90° scattered light measurement is determined. This procedure compensates for the light that is diminished by the colour of the sample. The influence of the colour of the sample may also be eliminated by using an infrared light-emitting diode (IR LED) at 860 nm as the light source of the instrument. The instrument’s photodiode detectors receive and measure scattered light at a 90° angle from the sample as well as measuring the forward scatter (light reflected) in front of the sample along with the measurement of light transmitted directly through the sample. The measuring results are given in NTU(ratio) and are obtained by calculating the ratio of the 90° angle scattered light measured to the sum of the components of forward scattered and transmitted light values. In ratio turbidimetry the influence of stray light becomes negligible. Nephelometers are used for measurements of the degree of opalescence of colourless liquids.
    比率透射比浊法测定的是透视光的测量和90°方向上散射光的测量之间的关系。这样的操作补偿了因样品颜色引起的光衰减。由样品颜色产生的影响也可以用红外发光二级管进行消除,在860nm处的光作为仪器光源。仪器的光电二级管检测器可以获得并测量在样品90°角方向上的散射光。就像测量朝前的散射光(反射光)一样,即当光直接沿浊被测样品通过,被测样品前方的散射光。测量结果以NTU(比率)给出,并通过计算在90°方向上测得的散射光,和向前的散射光和透射光值之和的比率而获得。在比率透射比浊法中,杂散光的影响变得微乎其微。比浊计用于无色溶液乳光度的测量。

    Measurements of reference suspensions I-IV with a ratio turbidimeter show a linear relationship between the concentrations and measured NTU values (see Table 2.2.1.-2). Reference suspensions I-IV (Ph. Eur.) may be used as calibrators for the instrument.
    用比率浊度计对参比悬浊液I-IV的测量,显示了浓度和测量的NTU值之间的线性关系。参比混悬液I-IV (Ph. Eur.)可以用来校正仪器。


    Table 2.2.1.-2
    Formazin suspensions
    福尔马肼悬浮液    Opalescent values (NTU)
    乳光值(NTU)
    Reference suspension I参比悬浊液I    3
    Reference suspension II参比悬浊液 II    6
    Reference suspension III参比悬浊液III    18
    Reference suspension IV参比悬浊液IV    30
    Standard of opalescence乳光标准    60
    Primary opalescent suspension
    乳光悬浊液储备液    4000

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  • yezi01

    第23楼2012/07/31

    Requirements in monographs are expressed in terms of the visual examination method with the defined reference suspensions. Instrumental methods may also be used for determining compliance with monograph requirements once the suitability of the instrument as described below has been established and calibration with reference suspensions I-IV and with water R or the solvent used has been performed.
    乳光的仪器测定在用准确的参比混悬液定义可见方法时已表明了要求。一旦后面所规定的建立了仪器的适应性,并用参比混悬液I-IV和水或使用的溶剂进行校正,文中的方法也使用于仪器校正。

    Apparatus. Ratio turbidimeters or nephelometers with selectable ratio application use as light source a tungsten lamp with spectral sensitivity at about 550 nm operating at a filament colour temperature of 2700 K, or IR LED having an emission maximum at 860 nm with a 60 nm spectral bandwidth. Other suitable light sources may also be used. Silicon photodiodes and photomultipliers are commonly used as detectors and record changes in light scattered or transmitted by the sample. The light scattered at 90 ± 2.5° is detected by the primary detector. Other detectors are those to detect back and forward scatter as well as transmitted light. The instruments used are calibrated against standards of known turbidity and are capable of automatic determination of turbidity. The test results expressed in NTU units are obtained directly from the instrument and compared to the specifications in the individual monographs.
    仪器:使用可选择的比率浊度计和浊度计时,用钨灯作光源,在2700K的谱线标记温度时,钨灯在大约550nm处有特殊选择性,或者用在860nm处有最大发射并且有60nm光谱宽度的红外发光二级管。也可以使用其他合适的光源。常用硅制光电二极管和光电倍增管作检测器,并记录因样品产生的光散射或光透射的改变。主要检测器检测在90 ± 2.5°方向上的光散射。其他的检测器检测朝后和朝前的光散射,就像测光透射一样。使用的仪器用已知浊度的标准溶液来校正,并能够自动测定浊度。从仪器上直接获得用NTU单位表示的测定结果,并且,在个别文中与规定进行比较。

    Instruments complying with the following specifications are suitable.
    根据后面的说明使用仪器

    —    Measuring units: NTU. NTU is based on the turbidity of a primary reference standard of formazin. FTU (Formazin Turbidity Units) or FNU (Formazin Nephelometry Units) are also used, and are equivalent to NTU in low regions (up to 40 NTU). These units are used in all 3 instrumental methods (nephelometry, turbidimetry and ratio turbidimetry).
    —    测量单位:NTU,NTU根据的是福尔马肼标准储备液的浊度。液使用FTU(福尔马肼浊度单位)或FNU(福尔马肼散射测浊法单位)单位,在低浊度范围内等于NTU(大于40NTU)。这些单位在散射测浊法、浊度法、比率浊度法,三种仪器方法中均可使用。
    —    Measuring range: 0.01-1100 NTU.
    —    测量范围:0.01-1100NTU

    —    Resolution: 0.01 NTU within the range of 0-10 NTU, 0.1 NTU within the range of 10-100 NTU, and 1 NTU for the range > 100 NTU. The instrument is calibrated and controlled with reference standards of formazin.
    —    分辨率:在0-10NTU范围内分辨率为0.01NTU,在10-100NTU范围内分辨率为0.1NTU,在>100NTU范围内分辨率为1NTU。用福尔马肼的参比标准校正和控制仪器。

    —    Accuracy: 0-10 NTU: ± (2 per cent of reading + 0.01) NTU. 10-1000 NTU: ± 5 per cent.
    —    精确度:0-10 NTU±(2%测量读数+0.01)NTU,10-1000 NTU: ± 5%

    —    Repeatability: 0-10 NTU: ± 0.01 NTU. 10-1000 NTU: ± 2 per cent of the measured value.
    —    重复性:0-10 NTU± 0.01 NTU,10-1000 NTU± 2%的测量值

    —    Calibration: with 4 reference suspensions of formazin in the range of interest. Reference suspensions described in this chapter or suitable reference standards calibrated against the primary reference suspensions may be used.
    —    校正:用在感兴趣范围内的4中福尔马肼参比混悬液。可以用按本章规定的参比混悬液或合适的相对于参比混悬液储备液标有刻度的参比标准来校正。

    —    Stray light: this is a significant source of error in low level turbidimetric measurement; stray light reaches the detector of an optical system, but does not come from the sample; < 0.15 NTU for the range 0-10 NTU, < 0.5 NTU for the range 10-1000 NTU.
    —    杂散光:在低水平的浊度测定中,杂散光是主要的误差来源。杂散光就是能到达光学系统的检测器,但不是由于样品而产生的光。0-10 NTU的范围内杂散光< 0.15 NTU,10-100NTU的范围内杂散光< 0.5 NTU。

    Instruments complying with the above characteristics and verified using the reference suspensions described under Visual method may be used instead of visual examination for determination of compliance with monograph requirements.
    符合上面的特性,并用在可见方法下规定的参比混悬液进行校正的仪器,在这范围内,这些仪器可替代可视检查,这些检查和文中要求一致。

    Instruments with range or resolution, accuracy and repeatability capabilities other than those mentioned above may be used provided they are sufficiently validated and are capable for the intended use. The test methodology for the specific substance/product to be analysed must also be validated to demonstrate its analytical capability. The instrument and methodology should be consistent with the attributes of the product to be tested.
    所提供的仪器的使用范围、分辨率、准确度、重复性、容量及其它上面提到的参数,这些是十分有效的并能够预期使用。对于分析特殊的物质/产品,也必须进行试验方法学验证来说明其分析能力。仪器和方法学应该和测试样品的特性一致。



    以上就是欧洲药典7.0的澄清度检测方法全部内容!!!

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  • mademoiselle

    第24楼2012/09/13

    特地注册,来膜拜ls!!!

    正在翻译,而且是凹凸的EP6.0...

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  • mademoiselle

    第25楼2012/09/13

    好像缺了Nephelometry散射测浊法,难道EP7.0没有?
    EP6有,而且内容不少呢。。

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  • poorlittle

    第26楼2012/09/13

    符合下列规格之仪器均适用

    yezi01(yezi01) 发表:Instruments complying with the following specifications are suitable.
    根据后面的说明使用仪器

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