GLOSSARY
Acceptance Criteria: Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures.
Active moiety: The molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance (21 CFR 314.108(a)). The active moiety is the entire molecule or ion, not the active site.
Detection Limit: The detection limit of an individual analytical procedure is the lowest amount of analyte in a sample that can be detected, but not necessarily quantitated as an exact value.
术语表
合格标准(Acceptance criteria)：分析结果的可接受数值限度，范围。
活性成分(Active moiety): 原料药中那些能起生理作用或药理作用的分子或离子，不包括那些使该药物分子成为酯，盐(包括带氢或配位键的盐)，或其它非共价键衍生物(比如，络合物，螯合物，或包合物)(21CFR 314.108(a)). 活性成分指的是整个分子或离子，而不是活性位置。
检测限(Detection limit)：分析方法的检测限指的是样品中被分析物能被检测出的最低量，但并不需要定量检测。
Drug Product: A finished dosage form, for example, a tablet, capsule, or solution that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients (21 CFR 314.3(b)).
Drug Substance/Active Ingredient: An active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body. The active ingredient does not include intermediates used in the synthesis of such ingredient. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect (21 CFR 210.3(b)(7) and 314.3(b)).
制剂(Drug product): 成品剂型，比如，片剂，胶囊，或包含某一原料药成分的溶液，通常还会有其它的一些组分，但这也不是必须的。(21 CFR 314.3(b))。
原料药/活性成分(Drug substance/active ingredient): 能在疾病的诊断，治疗上，缓解，处理或预防中起到药理作用或其它直接作用的成分，也包括能影响人体的结构和功能的成分。原料药不包括那些在该原料药的合成过程中所用到的中间体。这个术语还包括那些在制剂生产过程中为产生化学变化的的组分，或以改变后的形式存在的制剂中以完成某一功能或作用的成分。(21 CFR 210.3(b)(7)和314.3(b))。
Placebo (or Blank): A dosage form that is identical to the drug product except that the drug substance is absent or replaced by an inert ingredient or a mixture of the drug product excipients quantitatively equivalent to those found in the drug product dosage form.
Quantitation Limit: The quantitation limit of an individual analytical procedure is the lowest amount of analyte in a sample that 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.
空白(Placebo or blank): 指不含活性成分，或用惰性成分代替了活性成分，而其它成分均与某一制剂保持一致的剂型。
定量限(Quantitation limit): 分析方法的定量限指的是样品中的被分析物可在适当的精密度和准确度下被定量检测出的最低量。检测量是低含量组分样品定量分析的一个参数，特别是用于杂质和/或降解物的测定。
Reagent: For analytical procedures, any substance used in a reaction for the purpose of detecting, measuring, examining, or analyzing other substances.
Specification: The quality standards (i.e., tests, analytical procedures, and acceptance criteria) provided in an approved application to confirm the quality of the drug substances, drug products, intermediates, raw materials, reagents, and other components including container closure systems, and in-process materials.
试剂(Reagent): 在分析方法中用于检测，测量，检查或分析其它物质的物质。
规格(specification): 质量标准(也就是，检测项，分析方法和合格标准)，提供在已批准的申请中以确认原料药，制剂，中间体，原辅料，试剂和其它组分，包括容器密闭系统，和过程控制物料的质量。
Spiking: The addition of a small known amount of a known compound to a standard, sample, or placebo, typically for the purpose of confirming the performance of an analytical procedure or the calibration of an instrument.
Stability-Indicating Assay: A validated quantitative analytical procedure that can detect the changes with time in the pertinent properties (e.g., active ingredient, preservative level) of the drug substance and drug product. A stability-indicating assay accurately measures the active ingredients without interference from degradation products, process impurities, excipients, or other potential impurities.
Working Standard: A standard that is qualified against and used instead of the reference standard (also known as in-house or secondary standard).
加样(Spiking): 往标准，样品或空白中加入少量已知量的已知物，特别是用于确认某一分析方法的性能或对仪器进行校准。
稳定性指示分析(Stability-indicating assay): 可以检测出原料药和制剂的相关属性(如，活性成分，防腐剂的量) 随着时间延长而产生的变化。稳定性指示分析能不受降解物，工艺杂质，赋形剂或其它潜在杂质的影响对活性成分进行测定。
工作对照品(Working standard): 根据一级标准品进行确认的对照品，并用以代替一级对照品。(也被称之为内部对照品或工作对照品)。
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