药典标准品和杂质标准品
药典标准品是指由国家药品监督管理局认定并公布的、用于药物质量控制的标准物质，其纯度、含量及稳定性等特性已经过严格验证。药典标准品在确保药品质量和安全性方面起着至关重要的作用。
杂质标准品则是指用于检测药物中可能存在的各种类型杂质的化学试剂或混合物。与药典标准品不同的是，杂质标准品不一定是单一化合物的标准品，它们可以是特定类型的杂质或是代表性的杂质混合物，旨在帮助制药企业进行质量控制和开发更为严格的生产工艺。
两者在药品生产和监管中都发挥着重要作用：药典标准品用于检测药物的主要成分是否符合规定的含量范围；而杂质标准品则有助于识别、定量分析并降低潜在的有害杂质，从而确保最终产品的安全性和有效性。在研发新药或改进现有药物的过程中，正确使用这些标准品可以有效提高产品质量和安全性评估水平。
| 中文名称 | 英文名称 | CAS号 | 化学式 |
|---|---|---|---|
| 西他列汀杂质10 | (R/S)-3-hydroxy-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-4-(2,4,5-trifluorophenyl)butan-1-one | 1253056-01-7 | C16H14F6N4O2 |
| 西他列汀杂质1 | (S)-Sitagliptin | 823817-55-6 | C16H15F6N5O |
| 西他列汀杂质 | (S)-3-tert-Butoxycarbonylamino-4-methanesulfonyloxybutanoic acid methyl ester | 382638-00-8 | C11H21NO7S |
| 西他列汀Defuoro杂质5 | 7-[(3R)-3-amino-4-(2,5-difluorophenyl)butanoyl]-3-(trifluoromethyl)-5,6,7,8-tetrahydro-1,2,4-triazolo[4,3-a]pyrazine | 486460-31-5 | C16H16F5N5O |
| 西他列汀-int A8 | methyl (3R)-3-amino-4-(2,4,5-trifluorophenyl)butanoate | 881995-69-3 | C11H12F3NO2 |
| 西他列汀-int A7 | methyl (3R)-3-amino-4-(2,4,5-trifluorophenyl)butyrate (R)-(-)-mandelate | 1253055-94-5 | C8H8O3*C11H12F3NO2 |
| 西他列汀-int A3 | (Z)-3-amino-4-(2,4,5-trifluorophenyl)-2-butenoic acid methyl ester | 881995-70-6 | C11H10F3NO2 |
| 西他列汀-N-硫酸盐 | Sitagliptin N-Sulfate | 940002-57-3 | C16H15F6N5O4S |
| 表洛伐他汀 | lovastatin | 79952-44-6 | C24H36O5 |
| 螺�f茂胺 | spiroxamine | 118134-30-8 | C18H35NO2 |
| 蝶酸 | pteroic acid | 119-24-4 | C14H12N6O3 |
| 藁本内酯 | Z-ligustilide | 81944-09-4 | C12H14O2 |
| 蒿素C | artepillin C | 72944-19-5 | C19H24O3 |
| 蒙莫西地那非 | homosildenafil | 642928-07-2 | C23H32N6O4S |
| 葫芦素 | cucurbitacin I | 2222-07-3 | C30H42O7 |
| 葡萄糖苷II | arjunglucoside II | 62369-72-6 | C36H58O10 |
| 葛根素-4'-Β-D-葡萄糖苷 | Puerarin-4'-O-beta-D-glucopyranoside | 117047-08-2 | C27H30O14 |
| 莫西沙星杂质Ⅳ | ethyl (2Z)-3-ethoxy-2-(2,4,5-trifluoro-3-methoxybenzoyl)acrylate | 866954-86-1 | C15H15F3O5 |
| 莫西沙星杂质RR(盐酸盐) | moxifloxacin hydrochloride | 1394029-14-1 | C21H24FN3O4*ClH |
| 莫西沙星杂质E | 8-Hydroxy Moxifloxacin Hydrobromide | 1292904-74-5 | C20H23BrFN3O4 |
| 莫西沙星杂质A(盐酸盐) | (-)-1-Cyclopropyl-7-([S,S]-2,8-diazabicyclo[4.3.0]non-8-yl)-6,8-difluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid hydrochloride | 151282-23-4 | C20H21F2N3O3*ClH |
| 莫西沙星杂质40 | ethyl 3-dimethylamino-2-(2,4,5-trifluoro-3-methoxybenzoyl)acrylate | 121577-35-3 | C15H16F3NO4 |
| 莫西沙星去羧基类似物 | moxifloxacin | 1322062-57-6 | C20H24FN3O2 |
| 莫西沙星乙酯杂质 | ethyl 1-cyclopropyl-6-fluoro-8-methoxy-7-((4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylate | 1403836-23-6 | C23H28FN3O4 |
| 莫西克汀EP杂质L | moxidectin | 119718-45-5 | C37H53NO8 |
| 莫美他松糠酸酯杂质D | [(1S,2S,10S,11R,13S,15S,17S)-14-(2-chloroacetyl)-2,13,15-trimethyl-5-oxo-18-oxapentacyclo[8.8.0.01,17.02,7.011,15]octadeca-3,6-dien-14-yl] furan-2-carboxylate | 83881-09-8 | C27H29ClO6 |
| 莫沙必利柠檬酰胺二钠盐 | Mosapride Citric Amide | 1215825-20-9 | C27H31ClFN3O9 |
| 莫昔沙星甲酯 | moxifloxacin methyl ester | 721970-35-0 | C22H26FN3O4 |
| 莫匹罗星钙(二水合物) | calcium;9-[(E)-4-[(2S,3R,4R,5S)-3,4-dihydroxy-5-[[(2S,3S)-3-[(2S,3S)-3-hydroxybutan-2-yl]oxiran-2-yl]methyl]oxan-2-yl]-3-methylbut-2-enoyl]oxynonanoate;dihydrate | 115074-43-6 | C52H90CaO20 |
| 莫匹罗星EP杂质E | 9-(((2E)-4-((2R,3RS,4aS,7S,8S,8aR)-3,8-Dihydroxy-2-((1S,2S)-2-hydroxy-1-methylpropyl)hexahydro-2H,5H-pyrano(4,3-b)pyran-7-yl)-3-methylbut-2-enoyl)oxy)nonanoic acid | 71087-96-2 | C26H44O9 |
| 莫匹罗星EP杂质D | 9-(((2E)-4-((2R,3aS,6S,7S)-2-((2S,3S)-1,3-Dihydroxy-2-methylbutyl)-7-hydroxyhexahydro-4H-furo(3,2-C)pyran-6-yl)-3-methylbut-2-enoyl)oxy)nonanoic acid | 71087-97-3 | C26H44O9 |
| 莫匹罗星EP杂质C | pseudomonic acid D | 85248-93-7 | C26H42O9 |
| 莫匹罗星 | mupirocin | 12650-69-0 | C26H44O9 |
| 莨菪灵 | 4-methyl-hexahydro-2,5-methano-furo[3,2-<i>b</i>]pyrrol-6-ol | 487-27-4 | C8H13NO2 |
| 荧光素二乙酸盐 | fluorescein diacetate | 596-09-8 | C24H16O7 |
| 草质素-7-O-(3''-β-D-葡萄糖基)-α-L-鼠李糖苷 | rhodiosin | 86831-54-1 | C27H30O16 |
| 草质素-3,8-二吡喃葡萄糖苷 | 5,7-dihydroxy-2-(4-hydroxyphenyl)-3,8-bis[[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy]chromen-4-one | 99224-12-1 | C27H30O17 |
| 茚酮二聚体 | 2-(5,6-dimethoxy-2,3-dihydro-1H-inden-1-ylidene)-5,6-dimethoxy-2,3-dihydro-1H-inden-1-one | 36159-03-2 | C22H22O5 |
| 茚达特罗杂质1 | Indacaterol impurity 1 | 1403389-05-8 | C24H30N2O3 |
| 茚地那韦 | Indinavir hydrate | 180683-37-8 | C36H49N5O5 |
| 苯达莫司汀杂质A | Bendamustine Impurity D | 191939-34-1 | C16H20ClN3O2S |
| 苯达莫司汀 | Deschloroethyl bendamustine | 1219709-86-0 | C14H18ClN3O2 |
| 苯肾上腺素相关化合物D | (R)-3-(2-(benzyl(methyl)amino)-1-hydroxyethyl)phenol | 1367567-95-0 | C16H19NO2 |
| 苯肾上腺素杂质 | (+)-Phenylephrine hydrochloride | 939-38-8 | C9H13NO2*ClH |
| 苯磺顺阿曲库铵杂质23 | 5-[3-[(1S,2S)-1-[(3,4-dimethoxyphenyl)methyl]-6,7-dimethoxy-2-methyl-3,4-dihydro-1H-isoquinolin-2-ium-2-yl]propanoyloxy]pentyl 3-[(1S,2S)-1-[(3,4-dimethoxyphenyl)methyl]-6,7-dimethoxy-2-methyl-3,4-dihydro-1H-isoquinolin-2-ium-2-yl]propanoate | 96946-55-3 | C53H72N2O12+2 |
| 苯磺酰胺,5-[2-[[2-(2-乙氧基苯氧基)乙基]氨基]丙基]-2-甲氧基盐酸盐 | (+)-Tamsulosin hydrochloride | 106463-19-8 | C20H28N2O5S*ClH |
| 苯甲酸阿格列汀杂质F | 2-{6-[3(R)-amino-piperidin-1-yl]-2,4-dioxo-3,4-dihydro-2H-pyrimidin-1-ylmethyl}-benzonitrile | 865758-98-1 | C17H19N5O2 |
| 苯甲酸环戊酯 | cyclopentyl benzoate | 32651-38-0 | C12H14O2 |
| 苯甲酰乙酸甲酯 | methyl 3-oxo-3-phenylpropionate | 614-27-7 | C10H10O3 |
| 苯氧甲基青霉素钾杂质D | p-hydroxyphenylpenicillin V | 20880-67-5 | C16H18N2O6S |
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