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 | 结构式图片 |
|---|---|---|---|---|
| 艾洛骨化醇 | Elocalcitol | 199798-84-0 | C29H43FO2 |
|
| 艾曲波帕杂质14 | 4'-hydroxy-3'-nitro-3-biphenylcarboxylic acid | 1097777-60-0 | C13H9NO5 |
|
| 艾司西酞普兰杂质 | citalopram propanoic acid | 91283-87-3 | C18H14FNO3 |
|
| 艾司西酞普兰杂质 | 1-oxo-1,3-dihydroisobenzofuran-5-carboxamide | 85118-25-8 | C9H7NO3 |
|
| 艾司洛尔酸钠 | 3-<4-<2-hydroxy-3-(isopropylamino)propoxy>phenyl>propionic acid hydrochloride | 83356-60-9 | C15H23NO4*ClH |
|
| 艾司洛尔酸 | 3-<4-<2-hydroxy-3-(isopropylamino)propoxy>phenyl>propionic acid | 81148-15-4 | C15H23NO4 |
|
| 色甘酸钠杂质 | 1-(2-acetyl-3-hydroxyphenoxy)-2,3-epoxypropane | 16130-28-2 | C11H12O4 |
|
| 色甘酸二乙酯 | 5,5’-[(2-hydroxy-1,3-propanediyl)bis(oxy)]bis-4-oxo-4H-1-benzopyran-2-carboxylic acid diethyl ester | 16150-45-1 | C27H24O11 |
|
| 舒马曲普坦中间体 | 3-(2-aminoethyl)-1H-indole-5-yl-N-methyl methane sulphonamide | 88919-22-6 | C12H17N3O2S |
|
| 舒巴坦杂质8 | (2S,5R,6S)-6β-bromo-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid,S,S-dioxide | 75527-88-7 | C8H10BrNO5S |
|
| 舒巴坦杂质18 | benzhydryl 6α-bromopenicillanate | 74189-25-6 | C21H20BrNO3S |
|
| 舒尼替尼甲酰胺杂质 | (Z)-5-((5-fluoro-2-oxoindolin-3-ylidene)Methyl)-2,4-diMethyl-1H-pyrrole-3-carboxaMide | 1186651-51-3 | C16H14FN3O2 |
|
| 脱羧氯雷他定杂质B | 13-Bromo-2-piperidin-4-ylidene-4-azatricyclo[9.4.0.03,8]pentadeca-1(11),3(8),4,6,12,14-hexaene | 117796-50-6 | C19H19BrN2 |
|
| 脱羧氧氟沙星 | ofloxacin | 123155-82-8 | C17H20FN3O2 |
|
| 脱羧恩氟沙星 | 7-(4-ethylpiperazin-1-yl)-1-cyclopropyl-6-fluoroquinolin-4-one | 131775-99-0 | C18H22FN3O |
|
| 脱羟基溴塞来考昔 | celecoxib | 170570-75-9 | C17H13BrF3N3O2S |
|
| 脱氯利伐沙班 | N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene-2-carboxamide | 1415566-28-7 | C19H19N3O5S |
|
| 脱氧索他洛尔 | Deoxysotalol | 16974-42-8 | C12H20N2O2S |
|
| 脱氧弗斯特罗定 | 2-{(1S)-3-[Di(propan-2-yl)amino]-1-phenylpropyl}-4-methylphenyl 2-methylpropanoate | 895137-81-2 | C26H37NO2 |
|
| 脱氢非洛地平 | Dehydrofelodipine | 96382-71-7 | C18H17Cl2NO4 |
|
| 脱氢阿立哌唑盐酸盐 | 7-(4-(4-(2,3-dichlorophenyl)piperazin-1-yl)butoxy)quinolin-2-one dihydrochloride | 1008531-60-9 | C23H25Cl2N3O2*2ClH |
|
| 脱氢利福曲汀乙酯 | ethyl 5(S)-(E)-7-[2-cyclopropyl-4-(4-fluorophenyl)-quinolin-3-yl]-5-hydroxy-3-oxo-6-heptenoate | 254452-91-0 | C27H26FNO4 |
|
| 脱氟8-羟基氟马西尼 | ethyl 8-hydroxy-5-methyl-6-oxo-5,6-dihydro-4H-benzo[f ]imidazo[1,5-a][1,4]diazepine-3-carboxylate | 131666-45-0 | C15H15N3O4 |
|
| 脱克拉定糖罗红霉素 | Decladinoseroxithromycin | 214902-82-6 | C33H62N2O12 |
|
| 脱乙酰基长春碱酰肼 | desacetylvinblastine monohydrazide | 55383-37-4 | C43H56N6O7 |
|
| 胍 | guanidine nitrate | 113-00-8 | CH5N3 |
|
| 胆碱非诺贝特杂质1 | 4'-chloro-2-hydroxybenzophenone | 2985-79-7 | C13H9ClO2 |
|
| 胃复安甲基物 | methyl 4-(acetylamino)-o-anisate | 4093-29-2 | C11H13NO4 |
|
| 肾上腺素红 | adrenochrome | 54-06-8 | C9H9NO3 |
|
| 肾上腺素磺酸 | (+/-)-epinine β-sulfonate < (+/-)-N-methyl-2-(3,4-dihydroxyphenyl)ethylammonium-2-sulfonate > | 26405-77-6 | C9H13NO5S |
|
| 肾上腺素杂质S | 4-(1-methoxy-2-methylamino-ethyl)-pyrocatechol; hydrochloride | 74571-90-7 | C10H15NO3*ClH |
|
| 肾上腺素杂质7 | leucoadrenochrome | 62322-82-1 | C9H11NO3 |
|
| 肾上腺素杂质27 | 1-(3,4-dihydroxy-phenyl)-ethanol | 37491-94-4 | C8H10O3 |
|
| 肾上腺素EP杂质D消旋体 | N-benzyladrenaline | 1095714-91-2 | C16H19NO3 |
|
| 聚普瑞锌杂质2 | 1-carboxy-2-n-propylaminocarbonylbenzene | 17332-34-2 | C11H13NO3 |
|
| 联苯-2-基氨基甲酸1-[2-(甲基氨基)乙基]哌啶-4-基酯 | biphenyl-2-ylcarbamic acid 1-(2-methylaminoethyl)piperidin-4-yl ester | 743460-48-2 | C21H27N3O2 |
|
| 羧基格列齐特 | Carboxy-Glyclazide | 38173-52-3 | C15H19N3O5S |
|
| 群多普利二酮哌嗪 | Trandolapril Diketopiperazine | 149881-40-3 | C24H32N2O4 |
|
| 羟甲唑啉EP杂质C | 4-tert-butyl-2,6-dimethyl-3-hydroxyphenylacetamide | 55699-13-3 | C14H21NO2 |
|
| 羟基阿达帕林 | 6-(3-(3-Hydroxytricyclo(3.3.1.13,7)dec-1-yl)-4-methoxyphenyl)naphthalene-2-carboxylic acid | 1346599-76-5 | C28H28O4 |
|
| 羟基苯达莫司汀 | 4-[5-[(2-chloroethyl)-(2-hydroxy-ethyl)amino]-1-methyl-benzimidazo-2-yl]-butanoic acid | 109882-27-1 | C16H22ClN3O3 |
|
| 羟基缬氨酸N-三氟乙酸盐 | Hydroxy Varenicline N-Trifluoroacetate | 357426-10-9 | C15H12F3N3O2 |
|
| 羟基多萘哌齐 | 2-((1-benzyl-piperidin-4-yl)-hydroxymethyl)-5,6-dimethoxyindan-1-one | 197010-20-1 | C24H29NO4 |
|
| 羟基去甲基波生坦 | Ro 64-1056 | 253688-62-9 | C26H27N5O7S |
|
| 羟基伊曲康唑(伊曲康唑代谢物) | Hydroxyitraconazole | 112559-91-8 | C35H38Cl2N8O5 |
|
| 羟基伊曲康唑 | Hydroxyitraconazole | 207970-87-4 | C35H38Cl2N8O5 |
|
| 羟基1-(3-氯苯基)-2-[(1,1-二甲基乙基)氨基]-1-丙酮盐酸盐 | (2R,3R)-2-(-3-chlorophenyl)-3,5,5-trimethyl-2-morpholinol | 357399-43-0 | C13H18ClNO2 |
|
| 羟基-Γ-山椒素 | hydroxy-γ-sanshool | 78886-66-5 | C18H27NO2 |
|
| 羟乙磺酸己氧苯脒 | hexamidine Diisethionate | 659-40-5 | 2C2H6O4S*C20H26N4O2 |
|
| 羟丙茶碱 | proxyphylline | 603-00-9 | C10H14N4O3 |
|
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