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 |
|---|---|---|---|---|
| 伊立替康杂质29 | 7-ethyl-1,2,6,7-tetrahydro-20-(S)-camptothecin | 797762-11-9 | C22H24N2O4 |
|
| 伊立替康杂质 | 1,4'-Bipiperidine, 1'-(phenylmethyl)- | 116269-53-5 | C17H26N2 |
|
| 伊曲康唑杂质E | trans-Itraconazole | 252964-65-1 | C35H38Cl2N8O4 |
|
| 伊曲康唑杂质B | 4-(4-(4-(4-(((2RS,4SR)-2-((4H-1,2,4-Triazol-4-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-2-sec-butyl-2H-1,2,4-triazol-3(4H)-one | 854372-77-3 | C35H38Cl2N8O4 |
|
| 伊伐布雷定相关化合物9 | 7,8-dimethoxy-1H-3-benzazepine-2,4(3H,5H)-dione | 85175-49-1 | C12H13NO4 |
|
| 伊伐布雷定杂质2单体 | 3-{3-[{[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}(methyl)amino]propyl}-7,8-dimethoxy-1,3,4,5-tetrahydro-2H-3-benzazepin-2-oneOn | 1616710-52-1 | C27H34N2O6 |
|
| 伊伐布雷定杂质16 | 1,3,4,5-Tetrahydro-3-[3-[[[(7S)-3-hydroxy-4-methoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl]methylamino]propyl]-7,8-dimethoxy-2H-3-benzazepin-2-one | 304464-98-0 | C26H34N2O5 |
|
| 伊伐布雷定杂质 | {2-[2-({3-[{[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-4,3,5-trien-7-yl]methyl}(methyl)-amino]propyl}amino)ethyl]-4,5-dimethoxyphenyl}acetic acid | 1462470-54-7 | C27H38N2O6 |
|
| 伊伐布雷定R-异构体盐酸盐 | ent-Ivabradine Hydrochloride | 148849-68-7 | C27H37ClN2O5 |
|
| 他达那非杂质D | (1R,3R)-1-(benzo[d][1,3]dioxol-5-yl)-2-(2-chloroacetyl)-N-methyl-2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxamide | 951661-81-7 | C22H20ClN3O4 |
|
| 他达那非杂质 | Tadalafil dioxolone | 1346602-17-2 | C22H17N3O5 |
|
| 他达那非二甲氧基杂质 | (6R,12aR)-6-(3,4-dimethoxyphenyl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione | 1356345-67-9 | C23H23N3O4 |
|
| 他达拉非杂质35 | (R)-Methyl 2-((benzo[d][1,3]dioxol-5-ylmethylene)amino)-3-(1H-indol-3-yl)propanoate | 749864-17-3 | C20H18N2O4 |
|
| 他达拉非杂质 | (2R,8R)-2-(1,3-Benzodioxol-5-yl)-6-oxa-3,17-diazatetracyclo[8.7.0.03,8.011,16]heptadeca-1(10),11,13,15-tetraene-4,7-dione | 479545-76-1 | C21H16N2O5 |
|
| 他达拉非中间体酯水解杂质 | (1R,3R)-1,2,3,4-tetrahydro-1-(3,4-methylenedioxyphenyl)-9H-pyrido[3,4-b]indole-3-carboxylic acid hydrochloride | 474668-76-3 | C19H16N2O4*ClH |
|
| 他莫昔芬EP杂质H | 4-(4-(2-(Dimethylamino)ethoxy)diphenylmethyl) tamoxifen | 809285-09-4 | C43H48N2O2 |
|
| 他唑巴坦酸相关物质A | 2-Amino-3-methyl-3-sulfino-4-(1H-1,2,3-triazol-1-yl)butanoic acid | 118175-11-4 | C7H12N4O4S |
|
| 他唑巴坦氯化物 | 2β-(chloro)methyl-2α-methyl-6,6-dihydropenam-3α-carboxylic acid benzhydryl ester | 85573-73-5 | C21H20ClNO3S |
|
| 他唑巴坦杂质B | tazobactam | 115546-66-2 | C10H12N4O5S |
|
| 他唑巴坦杂质 | benzhydryl 2α-chloromethyl-2β-methyl-6,6-dihydropenam-3α-carboxylate | 115546-67-3 | C21H20ClNO3S |
|
| 他克莫司杂质14 | allylmalonyl-SNAC thioester | 1260758-24-4 | C10H15NO4S |
|
| 他克莫司杂质12 | XB5YB7L8RD | 143210-33-7 | C43H69NO11 |
|
| 他克莫司开环 | Oxacyclohexane open ring tacrolimus | 144432-23-5 | C44H71NO13 |
|
| 他克莫司31-DMT | 31-O-desmethyl-tacrolimus | 127984-76-3 | C43H67NO12 |
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| 亚磷酸三苄酯 | tribenzyl phosphite | 15205-57-9 | C21H21O3P |
|
| 亚硝基环丙烷 | trans-Nitrosocyclopropan | 28017-92-7 | C3H5NO |
|
| 亚砜克林霉素 | (2R)-N-[2-chloro-1-[(3R,4R,6R)-3,4,5-trihydroxy-6-methylsulfinyloxan-2-yl]propyl]-1-methyl-4-propylpyrrolidine-2-carboxamide;hydrochloride | 22431-46-5 | C18H34Cl2N2O6S |
|
| 亚氨基二苄 | 9,10-dihydrodibenz<b,f>azepine | 494-19-9 | C14H13N |
|
| 二苯并氮杂卓-10,11-二酮 | 5H-dibenzo[b,f]azepine-10,11-dione | 19579-83-0 | C14H9NO2 |
|
| 二羟苯达莫司汀杂质 | 4-[1-Methyl-5-[bis(2-hydroxyethyl)amino]benzimidazolyl-(2)]butansaeure-hydrochlorid | 109882-29-3 | C16H23N3O4*ClH |
|
| 二羟基莫索尼定 | 5-[(4,5-Dihydro-1H-imidazol-2-yl)amino]-6-hydroxy-2-methyl-4(3H)-pyrimidinone | 352457-32-0 | C8H11N5O2 |
|
| 二羟基苯达莫司汀 | 4-<1-Methyl-5-<bis(2-hydroxyethyl)amino>benzimidazolyl-(2)>butansaeure | 109882-30-6 | C16H23N3O4 |
|
| 二羟基孕甾-1,4,9(11)三烯-3,20-酮-21-醋酸酯 | 21-Acetoxy-16α,17α-dihydroxy-1,4,9(11)-pregnatrien-3,20-dion | 77017-20-0 | C23H28O6 |
|
| 二硫氨磷汀 | N'-[2-[2-(3-aminopropylamino)ethyldisulfanyl]ethyl]propane-1,3-diamine;tetrahydrochloride | 10027-65-3 | C10H30Cl4N4S2 |
|
| 二硫代乙基碳萘甲醚 | Dithiodesethylcarbodenafil | 1610830-81-3 | C22H28N6OS2 |
|
| 二硫代-脱甲基-昔多芬 | 5-[2-ethoxy-5-(4-methylpiperazin-1-yl)thiocarbonyl]phenyl-1-methyl-3-n-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidine-7-thione | 1333233-46-7 | C23H30N6OS2 |
|
| 二盐酸西替利嗪杂质D | 1,4-Bis[(4-chlorophenyl)phenylmethyl]piperazine dihydrochloride | 856841-95-7 | C30H30Cl4N2 |
|
| 二盐酸(+)-N-(1(S)-苯基乙基)-1-氮杂二环[2.2.2]辛烷-3(R)-胺 | (+)-N-(1(S)-Phenylethyl)-1-azabicyclo[2.2.2]octan-3(R)-amine hydrochloride | 120570-09-4 | C15H24Cl2N2 |
|
| 二甲萘烷醇 | (-)-geosmin | 19700-21-1 | C12H22O |
|
| 二甲基苯乙烯 | 2,3-dimethylstyrene | 27496-76-0 | C10H12 |
|
| 二甲基利扎曲坦盐酸盐 | Didemethyl Rizatriptan Hydrochloride | 1016900-28-9 | C13H16ClN5 |
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| 二甲双胍杂质3 | (N’,N’-dimethylcarbamimidoyl)urea | 98026-16-5 | C4H10N4O |
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| 二甲双胍杂质 | 1-benzyl-2-(1-(2,3-dimethylphenyl)vinyl)-1H-imidazole | 944268-65-9 | C20H20N2 |
|
| 二甲双胍EP杂质E | metformin | 1609-00-3 | C3H9N5 |
|
| 二氢欧山芹素吡喃葡萄糖苷 | Columbianetin glucopyranoside | 55836-35-6 | C20H24O9 |
|
| 二氢三尖杉宁碱e | Dihydrocephalomannine | 159001-25-9 | C45H55NO14 |
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| 二氢-1H,3H,5H-吡咯并[1,2-a]噻唑并[3,4-d]吡嗪-5,8,10(5aH,10aH)-三酮 | Pidotimod Impurity Y | 161771-76-2 | C9H10N2O3S |
|
| 二氟阿托伐他汀 | (3R,5R)-7-[2,3-di-(4-fluorophenyl)-5-isopropyl-4-(phenylamino)-carbonyl]-1H-pyrrol-3,5-dihydroxy-1-heptanoic acid | 693794-20-6 | C33H34F2N2O5 |
|
| 二氟比鲁卡胺 | N-[4-cyano-3-(trifluoromethyl)phenyl]-3-(phenyl)sulfonyl-2-hydroxy-2-methyl-propanamide | 90357-05-4 | C18H15F3N2O4S |
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| 二异丙基联亚氨基二碳胺 | bis(1-methylethyl) 1,2-hydrazinedicarboxylate | 19740-72-8 | C8H16N2O4 |
|
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