美国药典（USP）标准品

美国药典（USP）标准物质

USP法定标准物质是原料药、辅料、杂质、降解产品、食品补充剂、药典试剂和性能校正剂的样品，其特性规定极严密。在进行法定 USP-NF 测试和化验时必须使USP 标准物质。

标准物质通常用于进行 USP-NF 的下列测试：

➣ 鉴定测试

➣ 杂质或相关化合物的有限测试

➣ 原料药和配方的化验

➣ 系统适用性测试

USP 标准物质也可以用作校正剂，用于溶出、粒子计数、熔点和滴定液标定，也可以用于空白和对照实验。标准物质主要用于色谱和光谱程序。

除基于 USP-NF 的标准物质之外，USP还向分析、临床、制药和研究实验室提供《食品化学法典》(Food Chemicals Codex)中规定的标准物质以及纯品(优质化学样品)。以及残留溶剂标准品。如：

USP残留溶剂标准品-Class 1

1601102 Residual Solvents Mixture – Class 1

1601146 Residual Solvent Class 1 – Benzene

1601168 Residual Solvent Class 1 – Carbon Tetrachloride

1601180 Residual Solvent Class 1 – 1,2-Dichloroethane

1601204 Residual Solvent Class 1 – 1,1-Dichloroethene

1601226 Residual Solvent Class 1 – 1,1,1-Trichloroethane

USP残留溶剂标准品-Class 2

1601281 Residual Solvents Cass 2 – Mixture A

1601292 Residual Solvents Class 2 – Mixture B

1601306 Residual Solvents Class 2 Mixture C

1601340 Residual Solvent Class 2 Acetonitrile

1601361 Residual Solvent Class 2 Chlorobenzene

1601383 Residual Solvent Class 2 – Chloroform

1601408 Residual Solvent Class 2 – Cyclohexane

1601420 Residual Solvent Class 2 – 1,2-Dichloroethene

1601463 Residual Solvent Class 2 – 1,2-Dimethoxyethane

1601485 Residual Solvent Class 2 – N,N-Dimethylaceta- mide

1601500 Residual Solvent Class 2 – N,N-Dimethylforma- mide

1601521 Residual Solvent Class 2 – 1,4-Dioxane

1601543 Residual Solvent Class 2 – 2-Ethoxyethanol

1601565 Residual Solvent Class 2 – Ethylene Glycol

1601587 Residual Solvent Class 2 –Formamide

1601601 Residual Solvent Class 2 – Hexane

1601623 Residual Solvent Class 2 – Methanol

1601645 Residual Solvent Class 2 – 2-Methoxyethanol

1601667 Residual Solvent Class 2 – Methylbutylketone

1601689 Residual Solvent Class 2 – Methylcyclohexane

1601441 Residual Solvent Class 2 – Methylene Chloride

1601703 Residual Solvent Class 2 – N-Methylpyrrolidone

1601725 Residual Solvent Class 2 – Nitromethane

1601747 Residual Solvent Class 2 – Pyridine

1601769 Residual Solvent Class 2 – Sulfolane

1601770 Residual Solvent Class 2 – Tetrahydrofuran

1601780 Residual Solvent Class 2 – Tetralin

1601805 Residual Solvent Class 2 – Toluene

1601827 Residual Solvent Class 2 – Trichloroethylene

1601849 Residual Solvent Class 2 – Xylenes

氯吡格雷及其三个相关杂质

1140430 Clopidogrel bisulfate CAS号：120202-66-6

1140586 Clopidogrel Related Compound A CAS号：144750-42-5

1140597 Clopidogrel Related Compound B CAS号：144750-52-7

1140600 Clopidogrel Related Compound C CAS号：120202-71-3