Q2(R1)中英文对照
REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR
HUMAN USE
人用药品的注册要求
ICH HARMONISED TRIPARTITE GUIDELINE
ICH协调的三方指导原则
VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND
METHODOLOGY
分析方法验证：正文和方法学
Q2(R1)
Current Step 4 version
现行第4阶段版本
Parent Guideline dated 27 October 1994
最初指导原则起于1994年10月27日
(Complementary Guideline on Methodology dated 6 November 1996
incorporated in November 2005)
（方法学补充指导原则完成于1996年11月6日，于2005年11月合并）
This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.
此指导原则由适当的ICH专家工作组起草，经调整团磋商，于ICH过程一致。在第四阶段，最终的草案推荐给欧盟，日本和美国的监管机构采用。
Q2(R1) Document History
developed to complement the Parent Guideline
PART I:
TEXT ON VALIDATION OF ANALYTICAL PROCEDURES
分析方法验证文件
ICH Harmonised Tripartite Guideline
ICH协调三方指导原则
Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 27 October 1994, this guideline is recommended for adoption to
the three regulatory parties to ICH
1994年10月27日的ICH策划委员会会议已经进入了ICH进程的第4阶段，此指导
原则推荐给ICH三个监管部门采纳
1. Introduction
This document presents a discussion of the characteristics for consideration during the validation of the analytical procedures included as part of registration applications submitted within the EC, Japan and USA. This document does not necessarily seek to cover the testing that may be required for registration in, or export to, other areas of the world. Furthermore, this text presentation serves as a collection of terms, and their definitions, and is not intended to provide direction on how to accomplish validation. These terms and definitions are meant to bridge the differences that often exist between various compendia and regulators of the EC, Japan and USA.
1．介绍
作为递交给欧共体，日本和美国新药注册申请资料的一部分，对分析方法验证需考虑事项的特征的讨论在此文件呈现出来。没有必要在此文件寻找覆盖在世界其他地区的药品的注册或出口所要求的测试。此外，此文作为术语的收集，和他们的定义而服务的，并没有想提供怎样完成验证的指示。这些项目和定义是连接那些常存在于欧共体，日本和美国的各种药典和规定之间的差异的桥梁。
The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. A tabular summation of the characteristics applicable to identification, control of impurities and assay procedures is included. Other analytical procedures may be considered in future additions to this document.
分析方法验证的目的是为了阐述分析方法是适用于它要分析的目的的。应用于鉴别，杂质控制和含量测定方法的特征项的综合，可能考虑会加入到今后的文件中。
2. Types of Analytical Procedures to be Validated
2．所要验证的分析方法的类型
The discussion of the validation of analytical procedures is directed to the four most common types of analytical procedures:
分析方法验证的讨论通常集中在以下分析方法的四个最通用的方面：
- Identification tests;
--鉴别试验；
- Quantitative tests for impurities' content;
--杂质含量的定量测试；
- Limit tests for the control of impurities;
--杂质控制的限度测试；
- Quantitative tests of the active moiety in samples of drug substance or drug product or other selected component(s) in the drug product.
--原料药或制剂或其他药品中选择性的组分的样品的活性部分的定量测试；Although there are many other analytical procedures, such as dissolution testing for drug products or particle size determination for drug substance, these have not been addressed in the initial text on validation of analytical procedures. Validation of these additional analytical procedures is equally important to those listed herein and may be addressed in subsequent documents.
虽然有许多其他的分析方法，诸如药品的溶解性试验或药品微粒大小测试，在分析方法验证最初的正文中并未给出。那些额外的分析方法的验证和在这里列出来的分析方法同样重要，且有可能在后来的文件中提出。
A brief description of the types of tests considered in this document is provided below.
对于此文件中考虑到的测试的类型的简短描述如下：
-Identification tests are intended to ensure the identity of an analyte in
a sample. This is normally achieved by comparison of a property of the
sample (e.g., spectrum, chromatographic behavior, chemical reactivity, etc) to that of a reference standard;
-鉴别试验是为了鉴定样品中某个分析物存在。通常将适当的样品与参考标准品进行比较（例如，光谱，色谱行为，化学反应等）。
-Testing for impurities can be either a quantitative test or a limit test for the impurity in a sample. Either test is intended to accurately reflect the purity characteristics of the sample. Different validation characteristics are required for a quantitative test than for a limit test; -杂质测试是对样品中的杂质进行定性或定量试验。这两种试验都是为了准确的反应样品中杂质的特性。与限度试验相比，定量试验要求不同的验证试验项。
-Assay procedures are intended to measure the analyte present in a given sample. In the context of this document, the assay represents a quantitative measurement of the major component(s) in the drug substance. For the drug product, similar validation characteristics also apply when assaying for the active or other selected component(s). The same validation characteristics may also apply to assays associated with other analytical procedures (e.g., dissolution).
-含量测试方法是为了测定给定样品中的被测物的量。此文件的内容中，含量测试代表原料药中的主成分的定量的测试。对于药物制剂中的活性组分或其他选择性组分进行含量测定时，相似的验证特征也同样应用。同样的验证特征也可以应用到与其他分析方法相关联的含量测试中（如，溶解）。
The objective of the analytical procedure should be clearly understood since this will govern the validation characteristics which need to be evaluated. Typical validation characteristics which should be considered are listed
below:
分析方法的目的应该清晰易懂，因为它将制约需要被评价的验证特征。应考虑的典型的验证特征如下：
Accuracy 准确度
Precision 精密度
Repeatability 重复性
Intermediate Precision 中间精密度
Specificity 特异性
Detection Limit 检测限
Quantitation Limit 定量限
Linearity 线形
Range 范围
Each of these validation characteristics is defined in the attached Glossary. The table lists those validation characteristics regarded as the most important for the validation of different types of analytical procedures. This list should be considered typical for the analytical procedures cited but occasional exceptions should be dealt with on a case-by-case basis. It should be noted that robustness is not listed in the table but should be considered at an appropriate stage in the development of the analytical procedure.
每一个验证特征在附属的术语中有定义。此表列出了那些验证特征，它们被认为是分析方法不同类型验证的最重要的部分。
Furthermore revalidation may be necessary in the following circumstances:
此外，以下情况可能有必要重新验证。
- changes in the synthesis of the drug substance;
-原料药合成路线变更；
- changes in the composition of the finished product;
-成品组分变更
- changes in the analytical procedure.
-分析方法变更
The degree of revalidation required depends on the nature of the changes. Certain other changes may require validation as well.
要求重新验证的程度取决于变更的性质。某些其他变更可能也要重新验证。
-表示此项特征通常不用评价
+ signifies that this characteristic is normally evaluated
+表示此项特征通常要评价
(1) in cases where reproducibility (see glossary) has been performed, intermediate precision is not needed
(1)如果重复性（见术语表）已经履行，中间精密度不做要求
(2) lack of specificity of one analytical procedure could be compensated by other supporting analytical procedure(s)
(2) 一个分析方法特异性缺乏，可以通过其他支持性的分析方法补充
(3) may be needed in some cases
(3)某些情况下可能需要
GLOSSARY
术语
1. ANALYTICAL PROCEDURE
The analytical procedure refers to the way of performing the analysis. It should describe in detail the steps necessary to perform each analytical test. This may include but is not limited to: the sample, the reference standard and the reagents preparations, use of the apparatus, generation of the calibration curve, use of the formulae for the calculation, etc.
1．分析方法
分析方法是指分析测试进行的方式。它应该详细地描述执行每个分析试验的必要的步骤。可能包括但不限于：样品，参考标准品和试剂制备，适用的仪器，标准曲线的产生，采用的计算公式，等等。
2. SPECIFICITY
Specificity is the ability to assess unequivocally the analyte in the presence of components which may be expected to be present. Typically these might include impurities, degradants, matrix, etc. Lack of specificity of an individual analytical procedure may be compensated by other supporting
analytical procedure(s).
This definition has the following implications:
Identification: to ensure the identity of an analyte.
Purity Tests: to ensure that all the analytical procedures performed allow an accurate statement of the content of impurities of an analyte, i.e. related substances test, heavy metals, residual solvents content, etc. Assay (content or potency):
to provide an exact result which allows an accurate statement on the content or potency of the analyte in a sample.
2．特异性（专属性）
特异性是指清晰地评价组分中认为可能存在的被测物的能力。典型的包括：杂质，降解产物，辅料等。
一个单独的分析方法的专属性缺乏，可以通过其他可支持的分析方法来补充。此定义有以下含义：
鉴别：确保某个分析物的身分。
纯度测试：确保所执行的所有分析方法对被测物的杂质的含量有一个准确的陈述，如，有关物质测试，重金属，残留溶剂，等。
含量测试（含量或效力）
提供准确的结果，对样品中被测物的含量或效力有准确的陈述。
3. ACCURACY
The accuracy of an analytical procedure expresses the closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value and the value found.
This is sometimes termed trueness.
3。准确度
分析方法的准确度表达了可接受值，包括常规真值或可接受的参考值，与测得值之间的一致性的接近程度。
4. PRECISION
4．精密度
The precision of an analytical procedure expresses the closeness of agreement (degree of scatter) between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed conditions. Precision may be considered at three levels: repeatability, intermediate precision and reproducibility.
分析方法的精密度表达了，在给定条件下，获得的一系列的同一均匀样品的多次取样的测量值之间的一致性的接近程度（分散度）。精密度可以从三个水平考虑：重复性，中间精密度。重现性。
Precision should be investigated using homogeneous, authentic samples. However, if it is not possible to obtain a homogeneous sample it may be investigated using artificially prepared samples or a sample solution.
精密度应该用同一均匀，权威样品进行考察。然而，如果不能获得同一均匀样品，可以用人工制备样品或样品溶液进行考察。
The precision of an analytical procedure is usually expressed as the variance, standard deviation or coefficient of variation of a series of
measurements.
分析方法的精密度常用一系列测量值的变异，标准偏差，或变异系数来表达。4.1. Repeatability
Repeatability expresses the precision under the same operating conditions over a short interval of time. Repeatability is also termed intra-assay precision.
4.1．重复性
重复性表示在短期时间间隔内，同样操作条件下的精密度。重复性也叫批内分析精密度。
4.2. Intermediate precision
Intermediate precision expresses within-laboratories variations: different days, different analysts, different equipment, etc.
4.2．中间精密度
中间精密度表示在同一试验室下的变异：不同天，不同试验者，不同仪器，等。
4.3. Reproducibility
Reproducibility expresses the precision between laboratories (collaborative studies, usually applied to standardization of methodology).
4.3．重现性
重现性表示试验室之间的精密度（合作性研究，通常用于分析方法学的标准化）。
5. DETECTION LIMIT
The detection limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be detected but not necessarily quantitated as an exact value.
5．检测限
一个分析方法的检测限是样品中分析物能被检测到但是没必要作为精确值定量的最小量。
6. QUANTITATION LIMIT
The quantitation limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy. The quantitation limit is a parameter of quantitative assays for low levels of compounds in sample matrices, and is used particularly for the determination of impurities and/or degradation products.
6．定量限
一个分析方法的定量限是样品中分析物能够定量测定，具有合适的精密度和准确度的最低量。定量限是样品基质中最低含量的化合物的定量分析的一个参数，特别用于测定杂质和/或降解产物。
7. LINEARITY
The linearity of an analytical procedure is its ability (within a given range) to obtain test results which are directly proportional to the concentration (amount) of analyte in the sample.
7．线性
分析方法的线性是获得的测试结果与样品中被测物的浓度成直接比例的能力。8. RANGE
The range of an analytical procedure is the interval between the upper and lower concentration (amounts) of analyte in the sample (including these concentrations) for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity.
8．范围
分析方法的范围是样品中被测物的最高浓度和最低浓度之间的间隔（包括最高和最低浓度），在此区间内，已经证明分析方法有合适的精密度，准确度和线性。
9. ROBUSTNESS
The robustness of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage.
9．耐用性
分析方法的耐用性是，在故意对分析方法的参数进行微小变化后，方法仍然能保持不受影响的能力的一种测试，并且提供在正常范围内使用的可靠性说明。
PART II:
VALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY ICH Harmonised Tripartite Guideline
第II部分:
分析方法的验证方法学
ICH协调的三方指导原则
Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 6 November 1996, and incorporated into the core guideline in November 2005, this guideline is recommended for adoption to the three
regulatory parties to ICH
INTRODUCTION
介绍
This document is complementary to the parent document which presents a discussion of the characteristics that should be considered during the validation of analytical procedures. Its purpose is to provide some guidance and recommendations on how to consider the various validation characteristics for each analytical procedure. In some cases (for example, demonstration of specificity), the overall capabilities of a number of analytical procedures in combination may be investigated in order to ensure the quality of the drug substance or drug product. In addition, the document provides an indication of the data which should be presented in a registration application .
最初文件给出了分析方法验证中应该考虑到的特征的讨论，此文件是最初文件的补充。它的目的是，在关于怎样考虑每个分析方法的各种验证特征方面，提供同样的指导和荐意。一些情况下，（例如，特异性的证明），为了确保原料药或制剂的质量，可以考察多个分析方法结合的全面的能力。此外，文件给出了在注册申请中要呈报的数据指示。
All relevant data collected during validation and formulae used for calculating validation characteristics should be submitted and discussed as appropriate.
所有在验证收集的相关的数据和用于计算的公式应该总结和做适当的讨论。Approaches other than those set forth in this guideline may be applicable and acceptable. It is the responsibility of the applicant to choose the validation procedure and protocol most suitable for their product. However it is important to remember that the main objective of validation of an analytical procedure is to demonstrate that the procedure is suitable for its intended purpose. Due to their complex nature, analytical procedures for biological and biotechnological products in some cases may be approached differently than in this document.
此指导原则中前面的那些方法以外的方法，也是可以应用或可以接受的。选择最适合于申请者的验证方法和草案，这是申请者的职责。由于性质复杂，生物和生物技术产品的分析方法在某些情况下可以和此文件中的方法不同。
Well-characterized reference materials, with documented purity, should be used throughout the validation study. The degree of purity necessary
depends on the intended use.
在验证研究过程的始终，应该采用有备有文件的纯度，性能好的参考物质。必须达到的纯度取决于应用的要求。
In accordance with the parent document, and for the sake of clarity, this document considers the various validation characteristics in distinct sections. The arrangement of these sections reflects the process by which an analytical procedure may be developed and evaluated.
根据最初文件，为了更清楚，此文件在不同的部分考虑到各种验证的特征。这些部分的安排反应了分析方法发展和评价的过程。
In practice, it is usually possible to design the experimental work such that the appropriate validation characteristics can be considered simultaneously to provide a sound, overall knowledge of the capabilities of the analytical procedure, for instance: specificity, linearity, range, accuracy and precision.
实际上，设计实验工作通常是可能的，这样能同时考虑到适当的验证特性，来提供对分析方法的能力的彻底的完整地认识，例如：特异性，线性，范围，准确度和精密度。
1. SPECIFICITY
An investigation of specificity should be conducted during the validation of identification tests, the determination of impurities and the assay. The procedures used to demonstrate specificity will depend on the intended objective of the analytical procedure.
It is not always possible to demonstrate that an analytical procedure is specific for a particular analyte (complete discrimination). In this case a combination of two or more analytical procedures is recommended to achieve the necessary level of discrimination.
1．特异性
特异性研究应该在鉴别试验，杂质鉴别试验和含量分析中进行。用于证明特异性的方法取决于分析方法的分析目标。
常常不太可能证明一个分析方法对于特定的分析物（完全区别）是专属的。在这种情况下，建议结合使用两个或多个分析方法来达到区别的必要水平。
1.1. Identification
Suitable identification tests should be able to discriminate between compounds of closely related structures which are likely to be present. The discrimination of a procedure may be confirmed by obtaining positive results (perhaps by comparison with a known reference material) from samples containing the analyte, coupled with negative results from samples which do not contain the analyte. In addition, the identification test may be applied to materials structurally similar to or closely related to the analyte to confirm that a positive response is not obtained. The choice of such potentially interfering materials should be based on sound scientific judgement with a consideration of the interferences that could occur.
1.1 鉴别
适当的鉴别试验应该能区别可能存在的结构相似的化合物。一个方法的区别可以通过获得含被测物样品的肯定的结果（可以通过与已知参考物质比较），和不含被测无样品的否定的结果来证实。此外，鉴别试验可以运用到与被测物结构相似的或相关的物质中来证明不能得到正反应。这类潜在的干扰物质的选择应该依据彻底的科学的判断，全面地考虑可能产生的干扰物。
1.2. Assay and Impurity Test(s)
For chromatographic procedures, representative chromatograms should be used to demonstrate specificity and individual components should be appropriately labelled. Similar considerations should be given to other separation techniques.
1.2 含量测试和杂质测试
对于色谱方法，代表性的色谱图应该用于证明专属性，且各个单独化合物应该适当地标记。相似的考虑应该用于其他分析技术。
Critical separations in chromatography should be investigated at an appropriate level. For critical separations, specificity can be demonstrated by the resolution of the two components which elute closest to each other. 色谱中临界性的分离应该进行适当程度地调查。临界性分离能够通过洗脱出来最接近的两个化合物的分离度来证明。
In cases where a non-specific assay is used, other supporting analytical procedures should be used to demonstrate overall specificity. For example, where a titration is adopted to assay the drug substance for release, the combination of the assay and a suitable test for impurities can be used.
在没有使用明确的含量分析的情况下，其他支持的分析方法应该用来证明全面的特异性。例如，采用滴定法测定原料药释放度的含量时，含量测定和适当的杂质试验可以结合使用。
The approach is similar for both assay and impurity tests:
含量分析和杂质测定的方法的方法是类似的。
1.2.1 Impurities are available
1.2.1 杂质是可以得到的
For the assay, this should involve demonstration of the discrimination of the analyte in the presence of impurities and/or excipients; practically, this can be done by spiking pure substances (drug substance or drug product) with appropriate levels of impurities and/or excipients and demonstrating that the assay result is unaffected by the presence of these materials (by comparison with the assay result obtained on unspiked samples).
对于含量分析，需要证明在杂质和辅料存在的情况下区别出被测物；实际操作中，可以将一定量的杂质和/或辅料加入到纯物质（原料药或制剂）中，证明含量分析结果在这些物质的存在下不受影响（通过比较不含加入物质的样品）。
For the impurity test, the discrimination may be established by spiking drug substance or drug product with appropriate levels of impurities and demonstrating the separation of these impurities individually and/or from other components in the sample matrix.
对于杂质测定，此项证明用在原料药或制剂中加入一定量的杂质，证明单独分离
这些杂质和/或将其与同样样品基质中的其他组分的分离开来进行。
1.2.2 Impurities are not available
1.2.2 杂质不可以得到
If impurity or degradation product standards are unavailable, specificity may be demonstrated by comparing the test results of samples containing impurities or degradation products to a second well-characterized procedure e.g.: pharmacopoeial method or other validated analytical procedure (independent procedure). As appropriate, this should include samples stored under relevant stress conditions: light, heat, humidity, acid/base hydrolysis and oxidation.
如果杂质或降解产物标准品不可以获得，特异性可以通过比较包含杂质或降解产物的样品的测试结果和另一个性能良好的分析方法，例如：药典方法或其他有效的分析方法（单独的方法）。适当地，应该包括在相对激烈条件下：光，热，湿度，酸/碱，氧化和还原。
- for the assay, the two results should be compared;
-对于含量分析，应该比较这两个结果；
- for the impurity tests, the impurity profiles should be compared.
-对于杂质测定，应该比较杂质的图形。
Peak purity tests may be useful to show that the analyte chromatographic peak is not attributable to more than one component (e.g., diode array, mass spectrometry).
峰纯度测试可能对于表明被测物色谱峰不是多于一个组分的峰归属（例如，二级管阵列DAD，质谱）很有用。
2. LINEARITY
2. 线性
A linear relationship should be evaluated across the range (see section 3) of the analytical procedure. It may be demonstrated directly on the drug substance (by dilution of a standard stock solution) and/or separate weighings of synthetic mixtures of the drug product components, using the proposed procedure. The latter aspect can be studied during investigation of the range.
应该在分析方法的范围（见第3部分）内评价线性关系。可以用指定的方法，直接证明原料药（通过标准溶液的稀释液）的线性和/或制剂组分的合成混合物的分别的权重来证明其线性。
Linearity should be evaluated by visual inspection of a plot of signals as a function of analyte concentration or content. If there is a linear relationship, test results should be evaluated by appropriate statistical methods, for example, by calculation of a regression line by the method of least squares. In some cases, to obtain linearity between assays and sample concentrations, the test data may need to be subjected to a mathematical transformation prior to the regression analysis. Data from the regression line itself may be helpful to provide mathematical estimates of the degree of linearity.
线性应该通过被测物浓度或含量的信号图作出可视检测图来评价。如果有线性关
系，测试结果应该通过合适的统计方法来评价，例如，用最小二乘法的一级回归线来计算。在某些情况下，为了得到含量测试结果和样品浓度之间的线性，测试数据可能需要在回归分析之前经过数学转换。线性回归得到的数据本身可能有助于提供线性程度的数学评价。
The correlation coefficient, y-intercept, slope of the regression line and residual sum of squares should be submitted. A plot of the data should be included. In addition, an analysis of the deviation of the actual data points from the regression line may also be helpful for evaluating linearity.
应该给出相关系数，y-截距，线性回归的斜率和剩余平方和。包括给出数据图。此外，从线性回归得到的实际数据点的偏差分析对于评价线性也非常有用。Some analytical procedures, such as immunoassays, do not demonstrate linearity after any transformation. In this case, the analytical response should be described by an appropriate function of the concentration (amount) of an analyte in a sample.
一些分析方法，例如免疫分析，在任何转换后没有进行线性。这种情况下，分析相应应该通过样品中被测无的浓度的合适的功能给与描述。
For the establishment of linearity, a minimum of 5 concentrations is recommended. Other approaches should be justified.
对于建立线性，最少要求5个浓度点。其他方法应该适当调整。
3. RANGE
3. 范围
The specified range is normally derived from linearity studies and depends on the intended application of the procedure. It is established by confirming that the analytical procedure provides an acceptable degree of linearity, accuracy and precision when applied to samples containing amounts of analyte within or at the extremes of the specified range of the analytical procedure.
特定的范围通常来源于线性研究并且取决于分析方法预定的应用。通过证实分析方法提供的线性，准确度和精密度的可接受度建立范围，测定的线性，准确度和精密度时，所用到的样品中含被测物的量应在分析方法指定的范围内或是在范围的极值。
The following minimum specified ranges should be considered:
应该烤炉到以下最小指定范围：
- for the assay of a drug substance or a finished (drug) product: normally from 80 to 120 percent of the test concentration;
-对于原料药或是成品（药物）制剂的含量分析：通常是测试浓度的80~120%；- for content uniformity, covering a minimum of 70 to 130 percent of the test concentration, unless a wider more appropriate range, based on the nature of the dosage form (e.g., metered dose inhalers), is justified;
-对于含量均一度测试，覆盖测试浓度的最小范围是70~130%，除非一个更宽的更合适的范围，根据剂型的性质（例如，压入型吸入剂），可以作出适当的调整。- for dissolution testing: +/-20 % over the specified range;
-对于溶解度测试：在指定范围的+/-20 %；
e.g., if the specifications for a controlled released product cover a region
from 20%, after 1 hour, up to 90%, after 24 hours, the validated range would be 0-110% of the label claim.
例如，如果控释制剂的规格覆盖的范围是从1小时后的20%到24小时的90%，标签声明的有效范围应该为1-110%。
-for the determination of an impurity: from the reporting level of an impurity1 to 120% of the specification;
-对于杂质测定：从杂质的报告水平到规格的120%；
-for impurities known to be unusually potent or to produce toxic or unexpected pharmacological effects, the detection/quantitation limit should be commensurate with the level at which the impurities must be controlled;
-对于有效的或是产生毒性或非预期的药效的已知杂质，检测/定量限应该与杂质应该控制的水平相当。
Note: for validation of impurity test procedures carried out during development, it may be necessary to consider the range around a suggested (probable) limit.
注：在研发期间执行的杂质测试方法的验证，可能有必要考虑到可能的限度的范围。
- if assay and purity are performed together as one test and only a 100% standard is used, linearity should cover the range from the reporting level of the impurities1 to 120% of the assay specification.
-如果含量和纯度测试作为一个试验进行，且只有用到一个100%的标准品，线性应该覆盖从杂质报道的水平到含量分析规格的120%。
4. ACCURACY
4. 准确度
Accuracy should be established across the specified range of the analytical procedure.
应该在分析方法指定范围内建立准确度。
4.1. Assay
4.1. 含量分析
4.1.1 Drug Substance
4.1.1 原料药
Several methods of determining accuracy are available:
测定准确度有几种方法可以用：
a) application of an analytical procedure to an analyte of known purity (e.g. reference material);
a) 分析方法应用到已知纯度的被测物中（例如，参考物质）；
b) comparison of the results of the proposed analytical procedure with those of a second well-characterized procedure, the accuracy of which is stated and/or defined (independent procedure, see 1.2.);
b)将预定的分析方法与的结果与另一个良好性能的方法的结果比较，得到的准确度进行统计和/或定义；
c) accuracy may be inferred once precision, linearity and specificity have
been established.
c)可以从已经建立的精密度，线性和特异性中推断准确度
4.1.2 Drug Product
4.1.2 药物制剂
Several methods for determining accuracy are available:
可以采用的集中测定准确度的方法：
a) application of the analytical procedure to synthetic mixtures of the drug product components（to which known quantities of the drug substance to be analysed have been added）;
a)按用于分析的已知药物制剂的量来药物制剂的各个组分进行混合，得到的样品采用分析方法进行分析。
b) in cases where it is impossible to obtain samples of all drug product components , it may be acceptable either to add known quantities of the analyte to the drug product or to compare the results obtained from a second, well characterized procedure, the accuracy of which is stated and/or defined (independent procedure, see 1.2.);
b) 在不能获得药物制剂的所有组分的情况下，或者向药物制剂中加入已知量的被测物，或者与另一个良好性能的方法所得到的结果进行比较，都是可以接受的，此法的准确度要进行统计和/或定义（单独方法，见1.2）；
c) accuracy may be inferred once precision, linearity and specificity have been established.
c) 可以从已经建立的精密度，线性和特异性项中推导准确度。
4.2. Impurities (Quantitation)
4.2．杂质（定量）
Accuracy should be assessed on samples (drug substance/drug product) spiked with known amounts of impurities.
应该用已知量的杂质加入到样品中（原料药/制剂）来评价准确度。
In cases where it is impossible to obtain samples of certain impurities and/or degradation products, it is considered acceptable to compare results obtained by an independent procedure (see 1.2.). The response factor of the drug substance can be used.
在不能获得某种杂质和/或降解产物的样品的情况下，可以考虑将用单独方法获得的结果进行比较（见1.2）。能采用原料药的响应因子。
It should be clear how the individual or total impurities are to be determined e.g., weight/weight or area percent, in all cases with respect to the major analyte.
应该明确单杂或总杂是怎样测定的，例如重量/重量或面积百分比，所有情况都与主要被测物相关。
4.3. Recommended Data
4.3 推荐数据
Accuracy should be assessed using a minimum of 9 determinations over a minimum of 3 concentration levels covering the specified range (e.g., 3 concentrations/3 replicates each of the total analytical procedure).
准确度的评价需采用指定范围内的最少9个测定点，最少3个浓度水平（例如，
用总分析方法测定3个浓度/每个浓度3个重复样品）
Accuracy should be reported as percent recovery by the assay of known added amount of analyte in the sample or as the difference between the mean and the accepted true value together with the confidence intervals.
准确度应该进行报道作为测定样品中被测物的已知加入量百分比回收率，或作为平均值与可接受真值的差异和置性区间。
5. PRECISION
5．精密度
Validation of tests for assay and for quantitative determination of impurities includes an investigation of precision.
含量测定和杂质的定量测定实验验证包括精密度研究。
5.1. Repeatability
5.1．重复性
Repeatability should be assessed using:
重复性的评价用到：
a) a minimum of 9 determinations covering the specified range for the procedure (e.g., 3 concentrations/3 replicates each);
a) 最少9个测试指覆盖分析方法的指定范围（例如，3个浓度/每个浓度3个重复样品）
or
或者
b) a minimum of 6 determinations at 100% of the test concentration.
b)最少6个测定值，浓度在100%的测定浓度
5.2. Intermediate Precision
5.2．中间精密度
The extent to which intermediate precision should be established depends on the circumstances under which the procedure is intended to be used. The applicant should establish the effects of random events on the precision of the analytical procedure. Typical variations to be studied include days, analysts, equipment, etc. It is not considered necessary to study these effects individually. The use of an experimental design (matrix) is encouraged.
应该建立的中间精密度的程度取决于方法所要应用的环境。申请者应该建立分析方法的精密度上的任意事件的影响。要研究的典型变异包括不同分析天，分析者，仪器，等。没有必要单独考虑这些因素。提倡使用实验设计（矩阵）。
5.3. Reproducibility
5.3．重现性
Reproducibility is assessed by means of an inter-laboratory trial. Reproducibility should be considered in case of the standardization of an analytical procedure, for instance, for inclusion of procedures in pharmacopoeias. These data are not part of the marketing authorization dossier.
重现性是通过内部实验室实验的方式来评价的。重现性应该考虑在分析方法标准化的情况下，例如，包含药典中的分析方法。这些数据不是市场授权档案的一部
分。
5.4. Recommended Data
5.4．推荐数据
The standard deviation, relative standard deviation (coefficient of variation) and confidence interval should be reported for each type of precision investigated.
应该给出所考察的每种的精密度的标准偏差，相对标准偏差（变异系数）和置信区间。
6. DETECTION LIMIT
6。检测限
Several approaches for determining the detection limit are possible, depending on whether the procedure is a non-instrumental or instrumental. Approaches other than those listed below may be acceptable.
测定检测限的几种方法都是可以的，取决于方法是一个非仪器方法还是仪器方法。除了那些列表中的方法外的方法是也可能是可接受的
6.1. Based on Visual Evaluation
6.1．根据目测评价
Visual evaluation may be used for non-instrumental methods but may also be used with instrumental methods.
目测不仅可以用于非仪器方法也可以用于仪器方法。
The detection limit is determined by the analysis of samples with known concentrations of analyte and by establishing the minimum level at which the analyte can be reliably detected.
检测限的测定是通过分析含已知浓度的被测物样品且建立可以检测的被测物的最低的浓度水平。
6.2. Based on Signal-to-Noise
6.2．根据信噪比
This approach can only be applied to analytical procedures which exhibit baseline noise.
此方法只能用于表现出基线噪音的分析方法。
Determination of the signal-to-noise ratio is performed by comparing measured signals from samples with known low concentrations of analyte with those of blank samples and establishing the minimum concentration at which the analyte can be reliably detected. A signal-to-noise ratio between 3 or 2:1 is generally considered acceptable for estimating the detection limit.
信噪比的测定，是通过比较测得的已知低浓度的样品信号和空白样品的信号，建立能够监测的被测物的最低浓度所得到的。信噪比在3或2：1之间通常被认为可接受的作为检测限的评价。
6.3 Based on the Standard Deviation of the Response and the Slope 6.3 根据响应和斜率的标准偏差
The detection limit (DL) may be expressed as:
检测限（DL）可以表达成：
DL = 3.3σ/ S
where σ = the standard deviation of the response
此处σ =响应的标准偏差
S = the slope of the calibration curve
S =标准曲线的斜率
The slope S may be estimated from the calibration curve of the analyte. The estimate of s may be carried out in a variety of ways, for example:
斜率S可以从被测物标准曲线中计算出来。s的计算可以用各种方法，例如：
6.3.1 Based on the Standard Deviation of the Blank
6.3.1 根据空白的标准偏差
Measurement of the magnitude of analytical background response is performed by analyzing an appropriate number of blank samples and calculating the standard deviation of these responses.
大量的分析的背景响应得测定是通过分析一定量的空白样品并计算这些响应的标准偏差来执行的。
6.3.2 Based on the Calibration Curve
6.3.2 根据标准曲线
A specific calibration curve should be studied using samples containing an analyte in the range of DL. The residual standard deviation of a regression line or the standard deviation of y-intercepts of regression lines may be used as the standard deviation.
应该用在含被测物浓度在检测限范围内的样品研究特定的标准曲线。回归线的剩余标准偏差或回归线y-截距的标准偏差可以作为标准偏差使用。
6.4 Recommended Data
6.4 推荐数据
The detection limit and the method used for determining the detection limit should be presented. If DL is determined based on visual evaluation or based on signal to noise ratio, the presentation of the relevant chromatograms is considered acceptable for justification.
应该给出检测限和用于测定检测限的方法。如果DL是根据目测或根据信噪比来测定的，相关的色谱的呈报应该认为其合理性是可接受的。
In cases where an estimated value for the detection limit is obtained by calculation or extrapolation, this estimate may subsequently be validated by the independent analysis of a suitable number of samples known to be near or prepared at the detection limit.
在检测限的估计值通过计算或推算得到的情况下，此推论可能随后要通过独立的分析适量的接近或在检测限浓度的样品来验证。
7. QUANTITATION LIMIT
7. 定量限
Several approaches for determining the quantitation limit are possible, depending on whether the procedure is a non-instrumental or instrumental. Approaches other than those listed below may be acceptable.
几种测定定量限的方法都是可以的，取决于方法是非仪器还是仪器方法。除了下面那些列举的方法外的方法都是可以接受的。
7.1. Based on Visual Evaluation
7.1．根据目测
Visual evaluation may be used for non-instrumental methods but may also be used with instrumental methods.
目测不仅可以用于非仪器方法也可以用于仪器方法。
The quantitation limit is generally determined by the analysis of samples with known concentrations of analyte and by establishing the minimum level at which the analyte can be quantified with acceptable accuracy and precision.
定量限的测定是通过分析含已知浓度的被测物样品且建立可以定量测定的被测物的最低的浓度水平。
7.2. Based on Signal-to-Noise Approach
7.2．根据信噪比
This approach can only be applied to analytical procedures that exhibit baseline noise.
此方法只能用于表现出基线噪音的分析方法。
Determination of the signal-to-noise ratio is performed by comparing measured signals from samples with known low concentrations of analyte with those of blank samples and by establishing the minimum concentration at which the analyte can be reliably quantified. A typical signal-to-noise ratio is 10:1.
信噪比的测定，是通过比较测得的已知低浓度的样品信号和空白样品的信号，建立能够监测的被测物的最低浓度所得到的。信噪比在10：1之间通常被认为作为定量限是可接受的。
7.3. Based on the Standard Deviation of the Response and the Slope
The quantitation limit (QL) may be expressed as:
（QL）可以表达成：
QL = 10σ/ S
where σ = the standard deviation of the response
此处σ =响应的标准偏差
S = the slope of the calibration curve
S =标准曲线的斜率
The slope S may be estimated from the calibration curve of the analyte. The estimate of s may be carried out in a variety of ways for example:
斜率S可以从被测物标准曲线中计算出来。s的计算可以用各种方法，例如：7.3.1 Based on Standard Deviation of the Blank
7.3.1 根据空白的标准偏差
Measurement of the magnitude of analytical background response is performed by analyzing an appropriate number of blank samples and calculating the standard deviation of these responses.
大量的分析的背景响应得测定是通过分析一定量的空白样品并计算这些响应的标准偏差来执行的。
NBA 篮球专业术语(英汉对照)
篮球术语 Jump ball 跳球 Travering 走步 Technical foul 技术犯规 3-second violation 3秒违例 Point scored 罚球 Personal foul 个人犯规 3-point shot 3分球 3-point line 3分线 Sideline 边线 Endline 端线 Midcourtline 中线 Center court 中场 Backboard 篮板 Free throw lane 罚球区 Offense 进攻 Defense 防守 Passing the ball 传球 Receiving the ball 接球 Shoot 投篮 Dunk 扣篮 Lay-up 檫板入蓝 Jump shot 跳投 Hook 勾手投篮 Dribbling 运球 Block off 防堵 Steal the ball 抢断球 Rebound 抢篮板球 Half-court offense 前场进攻 Fast-break offense 快攻 Playing big 高大中锋战术 Playing small 小个子战术 Spreading the court 拉开进攻 Setting up plays 组织进攻 Screen 掩护 Pick and roll 掩护转身切入 Give and go 传切上篮 Posting up 策应 Three-point shooting 三分球战术Isolations 孤立打法 Drawing a foul 导致对方犯规Blocking out 抢篮板时将对方挡在外面Man to man 人盯人
弹簧术语中英文对照
弹簧术语-中英文对照 给你一个术语参照，对着看吧弹簧术语-中英文对照 线径Wire diameter(d) 外径Outside of diameter(O.D) 内径Inside of diameter(I.D) 中心径Mean coil diameter(C.D) 有效圈数Active coil Number(Na) 总圈数Total number of coils(Nt) 自由长度Free length(F.L) 自由高度Free height 自由角度Free angle 卷方向Winding 右旋Right hand screw 左旋Left hand screw 材质Material 一般钢线SWC 琴钢线SWP-B(For press force) SWP-A(For pull force) 不锈钢线Stainless steel 闭端研磨Closed and ground 低温热处理Low temperature heat treatment 万能材料试机Universal test machine 安全荷重Total safe load 最大荷重Maximum load 压时之荷重Load at pressing length 防锈油Prevent rust oil 电镀Electroplating 电解Electrolytic 镀洛Chroming 镀锌Zinc-plating 五彩镀锌Colored-plating 染黑Black-dyeing 烤漆Paint drying 钝化Passivating 永久变形Permanent Set 斜率Rate(R) 移除Remove 立定处理Setting 应力消除Stress relieve
中英文对照自我介绍范文6篇
中英文对照自我介绍范文6篇Self introduction model in Chinese and English 编订：JinTai College
中英文对照自我介绍范文6篇 前言：自我介绍是向别人展示你自己，直接关系到你给别人的第一印象的好坏及以后交往的顺利与否，也是认识自我的手段。自我介绍是每个人都必然要经历的一件事情，日常学习、工作、生活中与陌生人建立关系、打开局面的一种非常重要的手段，通过自我介绍获得到对方的认识甚至认可，是一种非常重要的技巧。本文档根据自我介绍内容要求和特点展开说明，具有实践指导意义，便于学习和使用，本文下载后内容可随意调整修改及打印。 本文简要目录如下：【下载该文档后使用Word打开，按住键盘Ctrl键且鼠标单击目录内容即可跳转到对应篇章】 1、篇章1：中英文对照自我介绍范文 2、篇章2：中英文对照自我介绍范文 3、篇章3：中英文对照自我介绍范文 4、篇章4：关于博士复试自我介绍中英文（中文篇）文档 5、篇章5：关于博士复试自我介绍中英文文档 6、篇章6：关于博士复试自我介绍中英文文档
在我们与陌生人初次会面，或者在一些特定的场合往往 需要做一下自我介绍，视情况而定是用英文还是中文做自我介绍。本文是小泰为大家整理的中英文对照自我介绍范文，仅供参考。 篇章1:中英文对照自我介绍范文 My name is not tall, Wang Xinmiao, plain, a small child, xin Simon, xin is composed of three gold, mean that I how great your, Simon is of three water means I'll career. It looks good, but my personality is really surprising, careless. I am careless, no matter what the exam in the noses of error just check not to come out, buy vinegar forgot to bring money, study forgot to bring my book... This kind of embarrassing things happened to me this careless. Ah! When can I get rid of this bad habit. Remember once, mom was not at home, I cook, do what good? Well do rice, I three times five divided by two is panning out. Here are more simple, add water plugged in, this is too easy I can get this done in a
NBA术语中英版
N B A术语中英版文档编制序号：[KKIDT-LLE0828-LLETD298-POI08]
场上用语： a flat shot:一个弧线低平的投篮 alley-oop:空接扣篮 Arena:比赛场；竞技场。比如Seattle的主场名叫Key Arena arc:三分线 Arm in the rim dunk :手肘插进篮筐的灌篮 Air ball：“三不沾”，投出的球什么都没碰到 Alley-oop:空中接力。一个运动员把球抛向空中，另一个队员在空中接住球把球扣入篮筐 ankle－breaker：脚踝终结者。指的是一些球员在告诉交叉运球过程中将防守队员弄到并导致其受伤。 and one：打进加罚,即加罚 a strong finish：有力的结束。球员强力灌篮后，解说员的解说词 away game：客场比赛 baby hook:小勾手 backcourt：后场 back to the basket:背筐 bank shot:擦板球 Baseline：底线。球场两端的边界线 behind-the-back:背后运球 between－the－leg:胯下运球 bounc:反弹传球 Box out:抢篮板球挡人，即抢篮板球时站在对手和篮之间，用身体挡住防守队员的动作backdoor cut：从两边底线往篮下的战术 Back pass:背后传球 backcourt violation：回场违例 baseball pass：快攻时的长传 baseline driver：底线切入的球员 be sidelined：不能上场，退出比赛 beat the shot clock：在出手时限结束之前（完成出手投篮的动作）。在出手时限结束之前（完成出手投篮的动作）.NBA规定进攻一方必须在内24秒出手投篮，但在球过中线以后在前场的发球后，必须在 14 内秒出手投篮，否则违例。 behind-the-back dribble：背后运球 Bench:替补队员 bench warmer：上场时间很少的球员，通常在场下把板凳都坐暖了 blocking foul：阻挡犯规 block out：卡位 Bounce pass:击地传球 Box out:抢篮板球挡人，即抢篮板球时站在对手和篮之间，用身体挡住防守队员的动作brick：球打在篮筐或篮板上被崩出来，许多公牛队的球迷在客队罚球时都手执一块上写“Brick”的牌子在罚球队员的眼前不停的晃动，扰乱他的视线，以达到干扰罚球的目的。 bury a shot：投篮命中 Buzzer beater：零秒出手，即投压哨球
面试自我介绍范文(中英文对照)
面试自我介绍范文（中英文对照） 面试自我介绍范文一段短短的自我介绍，事实上是为了揭开更深入的面谈而设计的。一、两分钟的自我介绍，宛如商品广告，在有限的时刻内，针对客户的需要，将自己最美好的一面，毫无保留地表现出来，别但要令对方留下深刻的印像，还要即时引发起购买欲。深圳聘请1、自我认识想一矢中的，首先必须认清自我，一定要弄清以下三个咨询题。你如今是干什么的？你今后要干什么？你过去是干什么的？这三个咨询题别是按时刻顺序从过去到如今再到今后，而是从如今到今后再到过去。其奥妙在于：假如你被雇用，雇主选中的是如今的你，他希翼利用的是今后的你，而这今后又基于你的历史和现状。因此，第一具咨询题，你是干什么的？如今是干什么的？回答那个咨询题，要点是：你是你自己，别是别的什么人。除非你把自己与别人区别开来，在共同点的基础上更强调别同点，否则你绝无可能在众多的应征求职者中夺魁。关于这第一具咨询题，自我反省越深，自我鉴定就越成功。随后，着手回答第二个咨询题：你今后要干什么？假如你申请的是一份举脚轻重的工作，雇主确信很关注你对以后的自我设计。你的回答要具体，合理，并符合你如今的身份，要有一具更别致的风格。然后，再着手回答最后一具咨询题：你过去是干什么的？你的过去固然都在履历上已有反映。你在面试中再度回答那个咨询题时，别可忽略之处是：别要抖降一具与你的今后毫别相干的过去。假如你中途完全改行，更要在描述你的执着、职业目标的一贯性上下些功夫。要做到这一点，又要忠实于事实和本人，最简单的办法是：寻到过去与今后的联系点，收集过去的资料，再按目标主次罗列。用如此的办法，以如今为动身点，以今后为目标，以过去为证实，最重要的是加深了你的自我分析和理解。事实上，在面试的时候别一定有机会或者有必要照搬你的大作，但这三个咨询题的内在联系点一定会体如今自我表述的整体感受中，使你的形象栩栩如生。2、投其所好清晰自己的强项后，便能够开始预备自我介绍的内容：包括工作模式、优点、技能，突出成就、专业知识、学术背景等。惟独短短一分钟，因此一切依然与该公司有关的好。假如是一间电脑软件公司，应说些电脑软件的话题；如是一间金融财务公司，便可跟他说钞票的事，总之投其所好。但有一点必须紧记：话题所到之处，必须突出自己对该公司能够作出的贡献，如增加营业额、减低成本、发掘新市场等。3、铺排次序内容的次序亦极重要，是否能抓住听众的注意力，全在于事件的编排方式。因此排在头位的，应是你最想他记得的情况。而这些情况，普通基本上你最得意之作。与此并且，可呈上一些有关的作品或纪录增加印像分。中文面试自我介绍范文：恭敬的各位考官、各位评委老师：经过考试，今天，我以本岗位笔试第一的成绩进入了面试。对我来说，这次机会显得尤为宝贵。我叫***，今年27岁。1997年7月我从**师范学校艺师美术专业打算内自费毕业。由于从97年起国家别再对自费生包分配，使我与太阳底下最光辉的职业失之交臂。幸好，当时河西马厂完小师资别脚，经人介绍，我在该完小担任了一年的暂时代课教师。回想起那段时光真是既甜蜜又美好，尽管代课工资很低，但听着同学们围在身旁老师、老师的叫个别停，看着那一双双充满信任的双眼，那一张张稚气的小脸，日子中的所有别快都顿时烟消云散了。我原想，即使别能转正，只要学校需要，算是当一辈子代课教师我也心甘愿意。别料，1998年起国家开始清退暂时工和代课教师，接到了学校的口头通知后，我怀着依依不舍的心情，悄悄地离开了学校。今天，我想经过此次考试重新走上说坛的愿望是那样迫切！我家共有三姊妹，两个姐姐在外打工，为了照应已上了年纪的父母，我向来留在他们周围。我曾开过铺子，先是经营工艺品，后又经营服装。但别论生意做得怎么得心应手，当一名光荣的人民教师始终是我心憧憬之并愿倾尽毕生心血去追求的事业。我曾多次参加考试，但都由于各种原因而未能实现梦想，但我暗下决心，只要有机会，我就向来考下去，直到理想实现为止。现在的我，历经日子的考验，比起我的竞争对手在年龄上我已别再有优势，但是我比他们更多了一份对孩子的爱心、耐心和责任心，更多了一份成熟和自信。教师那个职业是神圣而伟大的，他要求教师别仅要有丰富的知识，
NBA必备英文词汇
N B A必备英文词汇Last revision on 21 December 2020
看NBA必备的篮球词汇大全球队一览： Eastern Conference 东部联盟 Boston Celtics 波士顿凯尔特人 New Jersey Nets 新泽西网 New York Knicks 纽约尼克斯 Philadelphia 76ers 费城76人 Toronto Raptors 多伦多猛龙 Chicago Bulls 芝加哥公牛 Cleveland Cavaliers 克里夫兰骑士 Detroit Pistons 底特律活塞 Indiana Pacers 印第安纳步行者 Milwaukee Bucks 密尔沃基雄鹿 Atlanta Hawks 亚特兰大老鹰 Charlotte Bobcats 夏洛特山猫 Miami Heat 迈阿密热火 Orlando Magic 奥兰多魔术 Washington Wizards 华盛顿奇才 Western Conference 西部联盟 Denver Nuggets 丹佛掘金 Minnesota Timberwolves 明尼苏达森林狼Oklahoma City Thunder 俄克拉何马城雷霆
Portland Trail Blazers 波特兰开拓者 Utah Jazz 犹他爵士 Golden State Warriors 金州勇士 Los Angeles Clippers 洛杉矶快船 Los Angeles Lakers 洛杉矶湖人 Phoenix Suns 菲尼克斯太阳 Sacramento Kings 萨克拉门托国王 Dallas Mavericks 达拉斯小牛 Houston Rockets 休斯敦火箭 Memphis Grizzlies 孟菲斯灰熊 New Orleans Hornets 新奥尔良黄蜂 San Antonio Spurs 圣安东尼奥马刺 球队组成： assistant coach：助理教练 backcourt：后卫组(包括控球后卫及得分后卫) backup：后备(替换，支持)球员 bench：(指全体)后备(替换，支持)球员 bench player：(指个人)后备(替换，支持)球员center：中锋(又称5号位置球员) coach：教练 frontline：锋线(包括大前锋，小前锋，中锋) GM(general manager)：球队经理
自我介绍(英文对照)
自我介绍（英文） 我是一个认真工作，认真钻研，勇于创新的人。能熟练运用电脑，掌握一定的office办公软件，与老师与同学保持着紧密的关系，乐于帮助同学解决学习与生活上的麻烦，善于总结归纳，善于沟通，有良好的敬业作风和团队合作精神。已熟悉与掌握本专业的相关知识，在大学4年间学会刻苦耐劳，努力钻研，学以致用，这就是我们所追寻的宝藏。 2.对待工作认真负责，善于沟通、协调有较强的组织能力与团队精神;活泼开朗、乐观上进、有爱心并善于施教并行;上进心强、勤于学习能不断提高自身的能力与综合素质。在未来的工作中，我将以充沛的精力，刻苦钻研的精神来努力工作，稳定地提高自己的工作能力，与公司同步发展。 3.积极主动、独立性强、具有高度的责任感和敬业精神，待人真诚、诚实守信、团结协作意识强，能够吃苦耐劳，勇于挑战新事物，具有一定的开拓创新能力，“踏实做事，诚实做人”是我为人处世的原则。 I am a man who works hard, studies hard and innovates. Able to skillfully use the computer, master office software, maintained a close relationship with teachers and classmates, ready to help classmates solve the trouble in study and life, be good at summarizing, good at communicating, has the good professional style and team work spirit. Familiar with the knowledge of this subject, I learned to work hard in the four years of college, study hard, and learn to use it. This is the treasure we seek. Be responsible for the work conscientiously, be good at communication and coordination with strong organization ability and team spirit; Lively, optimistic, caring and good at teaching in parallel; Self-motivated and diligent in learning can improve our ability and comprehensive quality. In future work, I will be with abundant energy, studies assiduously the spirit to work hard, steadily improve their ability to work, and the company synchronous development. 3. Initiative, independence is strong, with high sense of responsibility and dedication, sincere, honest and trustworthy, a strong sense of solidarity and collaboration, can bear hardships and stand hard work, have the courage to challenge the new things, have certain innovation ability, "practical work, be honest" is our principle of human behavior.
篮球英文专业术语
与篮球相关的英文词汇 篮球：basketball 1.篮球场上的位置 控球后卫Point guard (PG) (1) 得分后卫Shooting guard (SG) (2) 大前锋Power forward (PF) (4) 中锋Center (C) (5) 2.常用术语 运球：dribble 双手交替运球－crossover 投篮命中率－field goalds（FGs） 三分球命中率－3-point FGs 盖帽－blocking 失误－turnovers 罚球－foul shot 篮板－rebound 攻方篮板－off.rebounds 守方篮板－def.rebounds 助攻－assists 争球－jump ball 攻方－offense
守方－defence 暂停－time－out 撞人犯规－charging 阻挡犯规－holding 推人犯规－pushing 技术犯规－technical offence（fouls）常规赛－regular season 季后赛－playoff 卡位－screens 人盯人－men－to－men defense 区域防守－zone defense 打成平分－tie 加时赛－overtime（OT） 3. 各种投篮方式 (slam) dunk：(强力)灌篮 bank shot：擦板球 double pump：拉杆式投篮(verb) fade-away shot：后仰式跳投 hook shot：钩射投篮 jump shot：跳投 layup：带球上篮
perimeter shot：中距离投篮 set shot：立定投篮 three-point shot：三分球 4. 各种统计术语 assist：助功 block shot：阻攻，盖火锅儿 defensive rebound：防守篮板球 field goal percentage：投球命中率 field goal：投球命中 free throw percentage：罚球命中率 free throw：罚球offensive rebound：进攻篮板球rebound：篮板球 scoring：得分 steal：抄截 three-point shot percentage：三分球命中率turnover：失误 5. 场地装备篇 backboard：篮板 back court：后场 freethrow lane：罚球圈，禁区
NBA篮球术语英文缩写
NBA 各种投篮方式 (slam) dunk：(强力)灌篮 bank shot：擦板球 double pump：拉杆式投篮(verb) fade-away shot：后仰式跳投 hook shot：钩射投篮 jump shot：跳投 layup：带球上篮 perimeter shot：中距离投篮 set shot：立定投篮 three-point shot：三分球 NBA 各种统计术语 assist：助攻 block shot：阻攻，盖火锅儿 defensive rebound：防守篮板球 field goal percentage：投球命中率 field goal：投球命中 free throw percentage：罚球命中率 free throw：罚球offensive rebound：进攻篮板球rebound：篮板球 scoring：得分 steal：抢断
three-point shot percentage：三分球命中率 turnover：失误 NBA场地装备 backboard：篮板 back court：后场 freethrow lane：罚球圈，禁区 freethrow line：罚球线 front court：前场 game clock：比赛用时钟 halftime：中场休息时间 hoop：篮框，篮圈 mid-court：中场 net：篮网 painted area：罚球圈，禁区 restricted area near the basket：禁区内篮框下的小圆圈区域 rim：篮框，篮圈 scoring table：记录台，记分台 shot clock：时限钟（进攻方在24秒内必须投篮，并且球必须触及篮框，否则即违例) three-point line：三分（球）线 top of the circle：靠近禁区顶端之三分（球）线附近 wing：（左、右两边）底线区域 NBA规则
英文自我介绍中英文对照【最新版】
英文自我介绍中英文对照 Good morning/afternoon teachers and classmates.I'm XXX.I am a girl of 13.My family including my father,mother and me.I like basketball best.In addition,I also like table tennis.My favorite food is carrots.I'm also very interested in snacks.What,I'm good at https://www.wendangku.net/doc/4615927081.html,ing the computer E-mail,shopping and even solve my problems in the study and the life is so convenient.So I put my computer as my good helper.As for reading,I've read about magic novel.Are these.Nice to meet you!I sincerely hope to make friends with you. 翻译: 好早上/下午老师和同学。我是XXX。我是一个13岁的女孩。我家包括我爸爸，妈妈和我。我最喜欢篮球。此外，我还喜欢桌上网球。我最喜欢的食物是胡萝卜。我现在也在小吃很感兴趣。什么，我很好的电脑。用电脑发邮件，购物，甚至解决我的问题研究中，生命是如此方便。所以我把我的电脑是我的好帮手。作为阅读，我读过一些关于魔法的小说。是这些。好见到你!我真诚地希望与你交朋友。
模具注塑术语中英文对照
根据国家规范，以下为部分塑料模具成形术语的规范翻译。 动模Movable Mould Moving Half 定模座板Fixed Clamp Plate Top Clamping Plate Top Plate 动模座板Moving Clamp Plate Bottom Clamping Plate Bottom Plate 上模座板Upper Clamping Plate 下模座板Lower Clamping Plate 凹模固定板Cavity-retainer Plate 型芯固定板Mould Core-retainer Plate 凸模固定板Punch-retainer Plate模套Die Body Die Sleeve Die Blank支承板Backing Plate Support Plate 垫块Spacer Parallel 支架Ejector Housing Mould Base Leg模头Die Head 模具分类8 Injection Mold 注塑模Plastic Rubber Mould 塑胶模Rubber Molding 橡胶成 形 Hot Chamber Die Casting 热室压铸Sand Mold Casting 砂模铸造 Extrusion Mold 挤出模Multi-Cavity Mold 多模穴模具 Palletizing Die 叠层模Plaster Mold 石膏 模Three Plates Mold 三板模Plain Die 简易模Pierce Die 冲孔模 Forming Die 成型模Progressive Die 连续模 Gang Dies 复合模Shearing Die 剪边模Cavity Die 型腔模 Riveting Die 铆合模Compression Molding 压缩成型Flash Mold 溢流式模具 Extrusion Mold 挤压式模具Split Mold 分割式模具Mould Cavity 型腔母模Mold Core 模芯公模Large Die Mold 大型模具Precise Die Mold 精密模具 Complex Die Mold 复杂模具Foaming Mould 发泡模具 Metal Die 金属模具Plastic Mold 塑料模具Tool Stamping Die Punch Die 冲压模具 Extrusion Die 挤压模具Graphite Die 石墨模具流道浇口部分Runner System 浇道系统Sprue Cold Material Trap 浇道冷料井Sprue Puller 拉杆 Runner Design 流道设计Main Runner 主流道 Secondary Runner 次流道Mould Gate Design 浇口设 计 Submarine Gate 潜伏浇口Tunnel Gate 隧道式浇口Pinpoint Gate 点浇口Fan Gate 扇形浇口 Side Gate 侧浇口Edge Gate 侧缘浇口 Tab Gate 搭接浇口Film Gate 薄膜浇口Flash Gate 闸门浇口Slit Gate 缝隙浇口 Dish Gate 盘形浇口Diaphragm Gate 隔膜浇口 Ring Gate 环形浇口Runnerless 无浇道 Sprueless 无射料管方式Long Nozzle 延长喷嘴方式 Sprue 浇口，溶渣Insulated/ Hot Runner 热浇 道Runner Plat 浇道模块Valve Gate阀门浇口Slag Well 冷料井Cold Slag 冷料渣 Sprue Gate 射料浇口Nozzle 射嘴 Sprue Lock Pin 料头钩销（拉料杆）注塑缺陷Flash 飞边Warpage 翘曲Air Trap 积风Blush 发赤Flow Line 流痕Splay 银纹Short Shot 短射Sink Mark 缩痕Streak 条纹Void 缩孔Weld Line 熔接线 Gas Mark 烧焦Cold Slug 冷斑Delamination 起皮Burr 毛刺Flaw Scratch 刮伤Gloss 光泽 Glazing 光滑Surface Check 表面裂痕Hesitation 迟滞注塑工艺Molding Conditions 成型条件Drying 烘干Barrel Temperature 料筒温度Melt Temperature 熔化温度 Mold Temperature 模具温度Injection Pressure 注塑压力Back Pressure 背压Injection Speed 注塑速度Screw Speed 螺杆转速Tensile Strength 抗拉强度T ensile Elongation 延伸率Flexural Modulus 弯曲模Flexural Strength 抗弯强度Shrinkage 收缩率Regrind Usage 次料使用Moulding 模塑机械设备 Lathe 车床Planer 刨床Miller / Milling Machine 铣床Grinder 磨床Driller 钻床Linear Cutting 线切割Electrical Sparkle 电火花Welder 电焊机Punching Machine 冲床Robot 机械手Common Equipment 常用设备EDM Electron Discharge Machining 放电加工3D Coordinate Measurement 三次元量床Boring Machine 搪孔机Contouring Machine 轮廓锯床Copy Grinding Machine 仿形磨床Cylindrical Grinding Machine 外圆磨床Die
英语自我介绍面试-中英文对照版
英语自我介绍面试-中英文对照版 虽然我们从小学就开始学英语，现在还有很多从幼儿园就已经开始学习英语了，但是对于现在的我们来说，英语口语仍然是一个大难题，长时间的学习，我们只是学会了做英语卷子，在工作中、面试中的口语都成了大难题，下面，范文大全网小编为您搜罗整理，心语自我介绍面试，一起来看看吧! 英语自我介绍面试 Good morning, everyone. Thank you for taking your time. It’s really my honor to have this opportunity to take part in this interview. Now, I would like to introduce myself briefly. My name is Doris. I am 23 years old and born in Qingdao. I graduated from Hebei University of Science and Technology. My major is English. And I got my bachelor degree after my graduation. I also studied Audit in Hebei Normal University of Science and Technology. I am very interested in English and study very hard on this subject. I had passed TEM-8 and BEC Vantage. I worked in an American company at the beginning of this year. My spoken English was improved a lot by communicating with Americans frequently during that period. I am very optimistic and easy to get along with. I have many friends. Teamwork spirit is very important in this age. I think if we want to make big achievement, it’s very important to learn how to cooperate with other people. My motto is "characters determine destity", so I alwarys remind myself to be honest and modest to everyone . A verd says "attitude is everything". If I get this job, I will put all my heart in it and try my best to do it well.
弹簧图纸上常用英文术语
弹簧图纸上常用的英文术语玖胜五金弹簧有限公司介绍英文弹簧图纸常用术语线径：Wire Diameter 内径：Inner Diameter 外径：Outer Diameter 小外径：Small Outer Diameter 大外径：Big Outer Diameter 中径：Mean Diameter 自由高度：Free Length 压并高度：Block Length 有效圈数：Active Coils 总圈数：Total Coils 圈数：Turns 节距：Pitch 展开长度：Wire Length 旋向：Coiled way/Coiling Direction 右旋：Rigth 左旋：Left 原材料：RAW-Material 材料规格:Material Specification 琴钢线：Music Wire 横弹性系数G: Shearing modulus
纵弹性系数E：Elasticity modulus 备注：Note 描述：Designation 公差：Tolerance 一般公差：General Tolerance 线性：Linear 角度：Angular 视角：Perspective 第三角法：3RD.Angle's/Third Angle Projection 参数：Parameter 比例：Scale 单位：Unit 地址：Site 尺寸：Size 日期：Date 绘图：Drawn by 绘图日期：Date Drawn 设计：Designed 校对：Checked/Check by 批准：Approved 修改：Modification 标准化：Standardized
MPA复试英语自我介绍(中英文对照)
MPA复试英语自我介绍（中英文对照） Good morning, my dear teachers and professors: 早上好，亲爱的老师、教授： I am glad to be here for this interview. First，let me introduce myself to you. My name is XXX. XX years old, born in XXX. I graduated from the University in XXXX. I began to work in XXXX. I had been a teacher for XX years, in the meantime，I served XX years primary school principals. in XXXX, I entered the Chinese Communist Party XXX district Party committee work, become a public servant. 很高兴来参加这次面试，首先，做个自我介绍。我的名字是XXX，今年XX岁，出生于XXX。我XXXX年大学毕业，XXXX年开始工作。我从教XX年，其中，有XX年时间担任小学校长。XXXX 年，我进入中共XX区委工作，成为一名公务员。 There are several reasons for my decision to learn MPA in Agricultural University Of Nanjing. 我决定报考南京农业大学MPA 有以下原因： The first, I am longing to a deeper understanding of public management , there is an urgent need to strengthen the system management knowledge, so I choose MPA. 首先，我渴望加深对公共管理的了解，迫切需要学习公共管理
NBA 篮球术语 中英文对照
NBA 篮球专业术语中英文对照 投篮方式篇： 扣篮：dunk 擦板球：bank shot 拉杆式投篮：double pump 后仰式投篮：fade-away shot 钩射投篮：hook shot 跳投：jump shot 带球上篮：layup 中距离投篮：perimeter shot 立定投篮：set shot 三分投篮：three-point shot 统计术语篇： 助攻：assist 盖帽：block shot 篮板球：rebound 防守篮板：defensive rebound 投篮命中：field goal 投篮命中率：field goal percentage 罚球：free trrow 进攻篮板：offensive rebound 得分：scoring 抢断：steal 三分球命中率：three-point shot percentage 失误：turn over 场地装备篇： 篮板、篮架：backboard 篮筐：hoop 篮网：net 篮圈、篮框：rim 记录台、记分台：scoring table 前场：front court 中场：mid-court 后场：back court 罚球圈：freethrow lane 罚球线：freethrow line 罚球区：painted area 合理冲撞区：restricted area near the basket 比赛用时钟：game clock 中场休息时间：halftime
时限钟（24秒计时器）：shot clock 三分线：three-point line 靠近进去顶端的三分球线附近：top of the circle 左右底线区域：wing 动作篇 (throw a) baseball pass：（快攻时)长传 (shoot) an air ball：(投)篮外空心球，“面包“ behind-the-back dribble：背后（换手）运球carrying the ball：“翻球” cross-leg dribble：胯下运球 dribble：运球 driving to the hoop：带球上篮 four-point play：投进3分球后因被犯规再罚进一分hacking：打手犯规 holding：拉手犯规 make the basket：投篮得分 make the hoop：投篮得分 monster dunk：狂猛灌篮 nothing but the net：空心球（入篮） palming：“翻球” reverse dunk：倒灌篮 reverse lay-up：反手走篮 shoot behind the arc：投三分球 score a basket：投篮得分 swish：空心球（入篮） tap in：托球入篮 three-point play：投进2分球后因被犯规再罚进一分球队球员篇 assistant coach：助理教练 backcourt：后卫组（包括控球后卫及得分后卫）backup：后备（替换，支持）球员 bench：（指全体）后备（替换，支持）球员bench player：（指个人）后备（替换，支持）球员center中锋（又称5号位置球员） coach：教练 frontline：锋线（包括大前锋，小前锋，中锋） GM（general manager）：球队经理 Mascot：球队吉祥物
弹簧术语中英文对照表
弹簧术语中英文对照表中文英文简写 线径 Wire diameter d 外径 Outside of diameter O.D 内径 Inside of dimeter I.D 中心径 Mean coil diameter C.D 有效圈数 Active coil Number Na 总圈数 Total number of coils Nt 自由长度 Free lengh F.L 自由高度 Free height F.H 卷方向 Winding 右旋 Right hand screw 左旋 Left hand screw 材质 Material 一般钢线 SWC 琴钢线 SWP-B(For press force) SWP-A(For pull force) 不锈钢线 Stainless steel 闭端研磨 Closed and ground 表面处理 Surface treatment 低温热处理 Low temperature heat treatment 万能材料试机 Universal test machine 安全荷重 Total safe load 最大荷重 Maximum load 压时之荷重 Load at pressing length 防锈油 Preventing rust oil 电镀 Electroplating 电解 Electrolytic 镀洛 Chroming 镀锌 Zinc-plating 五彩镀锌 Colored-plating 染黑 Black-dyeing 烤漆 Paint drying 钝化 Passivating 永久变形 Permanent set 斜率 Rate (R) 移除 Remove 立定处理 Setting 应力消除 Stress relieve 弹簧刚度产生单位变形量的弹簧负荷 Spring constant 强压（拉、扭）处理 Prestressing 开口不磨平 Open ends, not ground 弹簧箍固紧簧板的金属箍 Buckle 冲击试验 Impact test 负荷 Load (P) 环 Loops 模量 Modulus 开口磨平 Open ends ground 铝板 Aluminum plate 中文英文 压实外径不超过 Outside dia sold, not more than 热处理加工品检报告 Heat-treatment QC report 钩 Hooks 自由内径不小于 Inside dia free , not less than 客户名称 customer 装配高度(基本) Assembled height (Basic) 出货单号 Job NO. 装配高度之负载 Load at assembled height 品名 Proname 压实高度不超过 Sold height , Not more than 硬度要求／硬度值 Hardness／Hardness value 线径(约) Dia of wire(approx) 变形量 Distortion 批号 Batber 两端闭合并磨平 Ends closed and ground flat 数量 TTL OTY. 操作高度(基本) Operating height (basic) 重量 TTL WT． 操作高度之负载 Load at operating height 弹性比率(参考) Spring rate (Ref) 依照规格式化MIL-S-13572制造,I型,A级,珠击 Manufacture in accordance wire spec MIL-S-13572 type I , gradea ,shot peen 高度18和12之间,负载变化为20+5KG Change in load between 18 and 12 height 20+5kg 注:钢,515H或50B60H.规格为QQ-S-624 notes:Steel 515H or 50B60H . Spec QQ-S-624 钢板 Stainless Plate 弹簧销 Spring pin 钢线弹簧 Spring wire 螺旋形状、螺旋线 Helix 氢脆变 Hydrogen embrittlement 初始负荷 Initial load 疲劳试验 Fatigue test 闭收口 Closed ends 磨平闭收口 closed and ground ends 密身 Close-wound Permanent deformation / Temporary deformation：永久变形弹簧卸荷后自由高度（长度、角度） Pre-set：To remove permanent set prior to application installation. Active number of coils(turns)：有效圈数计算弹簧刚度时的圈数 Axial pitch：轴向节距截锥涡卷弹簧轴向的节距 Angular relationship of ends：收口的角关系拉簧的钩环的相对位置 Baking：Heating of electroplated springs to relieve hydrogen embrittlement. Characteristic：弹簧特性工作负荷与变形量之间的关系 Diameter of wire cord：索径多股螺旋弹簧钢索直径 Deflection：变形量（挠度）弹簧沿负荷方向产生的相对位移 Deflection at ultimate load：极限负荷下的变形量弹簧在极限负荷下沿作用方向产生的相对位移 Free height(length)：自由长度（高度）弹簧无负荷时的长度（高度） Free angle：自由角度扭转弹簧无扭矩作用时两臂的夹角 Height(length) at ultimate load：极限高度（长度）弹簧承受极限负荷时的长度（高度） Hot-setting：加温立定处理在高于弹簧工作温度条件下的立定处理 Initial tension (Pi)：初如拉力密圈螺旋拉伸弹簧在冷卷时形成的内力，其值为弹簧开始产生拉伸变形时所需要的作用力 Mean diameter or coils：弹簧中径弹簧内径和中径的平均值 Modulus in compression：压缩模量橡胶弹簧在压缩时的弹簧模量 Number of end coils：支承圈数弹簧端部用于支承或固定的圈数 Pitch：节距螺旋弹簧两相邻有效圈截面中心线的轴向距离 Pitch of wire cord：索距多股螺旋弹簧钢索中钢丝的导程 Radial pitch：径向节距截锥涡卷弹簧径向的节距 Spring flexibility：弹簧柔度单位工作负荷下的变形量 Spccified load：工作负荷弹簧工作过程中承受的力或扭矩 Torque (M)：扭矩，转矩扭簧的弯曲动作，等于负荷乘以从负荷到弹簧轴向的移动距离 Twist angle of strands：索拧角多股螺旋弹簧钢索中心线与钢丝中心线的夹角 Total number of coils(turns)：总圈数 Ultimate load：极限负荷对应于弹簧材料屈服极限的负荷 Ultimate torsional angle：极限扭转角扭转弹簧承受极限负荷时的角位移 Working ultimate load：工作极限负荷弹簧工作中可能出现的最大负荷 Working height((length)：工作高度（长度）弹簧承受工作负荷时的长度（高度）的变化不能恢复的部分称为永久变形，能恢复的称为暂变形或滞弹性变形 Working torsional angle：工作扭转角扭转弹簧承受工作负荷时的角位移