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 |
|---|---|---|---|---|
| 5-氯-1-(四氢-2-呋喃)-2,4(1H,3H)-嘧啶二酮 | 1-(Tetrahydro-2-furyl)-5-chlorouracil | 17902-24-8 | C8H9ClN2O3 |
|
| 5-氨磺酰基-2-甲氧基苯甲酸 | 2-Methoxy-5-sulfamoylbenzoic acid | 22117-85-7 | C8H9NO5S |
|
| 5-氨基-金刚烷-1,3-二醇 | 3,5-dihydroxyadamantan-1-amine | 1382839-19-1 | C10H17NO2 |
|
| 5-氨基-N-(2-羟基乙基)-2,4,6-三碘间甲酰苯甲酸 | 5-amino-N-(2-hydroxyethyl)-2,4,6-triiodoisophthalamic acid | 22871-58-5 | C10H9I3N2O4 |
|
| 5-氨基-3-羧基-2,4,6-三碘-N-甲基苯甲酰胺 | N-Methyl-2.4.6-trijod-5-amino-isophthalamidsaeure | 2280-89-9 | C9H7I3N2O3 |
|
| 5-氨基-2-羟基苯-1,3-二羧酸 | 5-amino-2-hydroxyisophthalic acid | 859964-08-2 | C8H7NO5 |
|
| 5-氧阿托伐他汀 | 5-Oxo Atorvastatin | 1391052-82-6 | C33H33FN2O5 |
|
| 5-氟利司哌酮 | 3-(2-(4-(5-fluorobenzo[d]isoxazol-3-yl)piperidin-1-yl)ethyl)-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one | 1199589-74-6 | C23H27FN4O2 |
|
| 5-氟-2-[3-(1-羟基乙基)-2,6-二(1-甲基乙基)-5-戊基吡啶-4-基]苯酚 | Methyl 5-sulpho-o-anisate | 94134-07-3 | C9H10O6S |
|
| 5-吡哆酸 | 5-hydroxy-4-hydroxymethyl-6-methyl-nicotinic acid | 524-07-2 | C8H9NO4 |
|
| 5-反式-比马前列素 | (5E)-N-ethyl-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]-cyclopentyl]hept-5-enamide | 1163135-95-2 | C25H37NO4 |
|
| 5-去[2-(叔-丁基氨基)]班布特罗-5-乙醇 | 5-Des[2-(tert-butylamino)] Bambuterol-5-ethanol | 112935-93-0 | C14H20N2O5 |
|
| 5-去[2-(叔-丁基氨基)]班布特罗-5-乙烯二醇 | 5-(1,2-dihydroxyethyl)-1,3-phenylene-N,N-dimethyl carbamate | 112935-92-9 | C14H20N2O6 |
|
| 5-亚烯丙基-10,11-二氢-5H-二苯并[a,d]环庚烯 | 5-(2-propenylidene)-10,11-dihydro-5H-dibenzo[a,d]cycloheptene | 24755-73-5 | C18H16 |
|
| 5-乙酰基-1,3-亚苯基二(二甲基氨基甲酸酯) | bis-3,5-(N,N-dimethylcarbamoyloxy)-acetophenone | 81732-48-1 | C14H18N2O5 |
|
| 5-乙烯基-2-吡咯烷酮 | 5-vinylpyrrolidin-2-one | 7529-16-0 | C6H9NO |
|
| 5-{4-[2-(5-乙基-2-吡啶基)-2-羟基乙氧基]苄基}-1,3-噻唑烷-2,4-二酮 | (+/-)-5-<p-<2-(5-ethyl-2-pyridyl)-2-hydroxyethoxy>benzyl>-2,4-thiazolinedione | 101931-00-4 | C19H20N2O4S |
|
| 5-[双(2-氯乙基)氨基]-1-甲基-1H-苯并咪唑-2-丁酸甲酯 | bendamustine methyl ester | 109882-25-9 | C17H23Cl2N3O2 |
|
| 5-[双(2-氯乙基)氨基]-1-甲基-1H-苯并咪唑-2-丁酸乙酯 | bendamustine ethyl ester | 87475-54-5 | C18H25Cl2N3O2 |
|
| 5-[[4-[(2,3-二甲基-2H-吲唑-6-基)氨基]-2-嘧啶基]氨基]-2-甲基苯磺酰胺 | Benzenesulfonamide, 5-((4-((2,3-dimethyl-2H-indazol-6-yl)amino)-2-pyrimidinyl)amino)-2-methyl- | 1252927-47-1 | C20H21N7O2S |
|
| 5-[[4-(羟基甲基)苯氧基]甲基]-3-异丙基-2-恶唑烷酮 | 5-[[4-(Hydroxymethyl)phenoxy]methyl]-3-(1-methylethyl)-2-oxazolidinone | 1071765-44-0 | C14H19NO4 |
|
| 5-[2,5-二甲基-4-(1-丙烯-1-基)苯氧基]-2,2-二甲基戊酸 | 5-(2,5-Dimethyl-4-(prop-1-en-1-yl)phenoxy)-2,2-dimethylpentanoic acid | 500904-61-0 | C18H26O3 |
|
| 5-[1-(2,3-二甲基苯基)乙烯基]-1H-咪唑 | 4-(1-(2,3-dimethylphenyl)vinyl)-1H-imidazole | 1021949-47-2 | C13H14N2 |
|
| 5-[(5-甲酰基呋喃-2-基)甲氧基甲基]呋喃-2-甲醛 | cirsiumaldehyde | 7389-38-0 | C12H10O5 |
|
| 5-[(2-乙氧基苯基)氨基]-6-羟基-4(3H)-嘧啶酮 | prunetin 5‐O‐glucoside | 89595-66-4 | C22H22O10 |
|
| 5-(环氧乙烷基甲氧基)-2,3,4,9-四氢咔唑 | 1,2,3,4-tetrahydro-5-(2,3-epoxy-propoxy)-carbazole | 58457-32-2 | C15H17NO2 |
|
| 5-(哌嗪-1-基)吡啶-2-胺 | 5-(piperazin-1-yl)pyridin-2-amine | 1082876-26-3 | C9H14N4 |
|
| 5-(二氟甲氧基)-2-{[(3,4-二甲氧基-1-氧代-2-吡啶基)甲基]硫基}-1H-苯并咪唑 | 5-(difluoromethoxy)-2-[[(3,4-dimethoxypyridin-2-yl-1-oxide)methyl]sulfanyl]-1H-benzoimidazole | 953787-51-4 | C16H15F2N3O4S |
|
| 5-(二氟甲氧基)-2-[[(3,4-二甲氧基-2-吡啶基)甲基]亚磺酰基]-1-甲基-1H-苯并咪唑 | N1-Methyl pantoprazole | 624742-53-6 | C17H17F2N3O4S |
|
| 5-(5-氯磺酰基-2-乙氧基苯基)-3-丙基-1,6-二氢-7H-吡唑并[4,3-d]嘧啶-7-酮 | 5-(5-Chlorosulfonyl-2-ethoxyphenyl)-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one | 139756-31-3 | C16H17ClN4O4S |
|
| 5-(3-硝基苯基)-3-甲基环己-2-烯酮 | 5-(3-nitrophenyl)-3-methylcyclohex-2-enone | 10323-98-5 | C13H13NO3 |
|
| 5-(3,4,5-三甲氧基苯甲酰基)-2,4-嘧啶二胺 | 2,4-diamino-5-(3,4,5-trimethoxybenzoyl)pyrimidine | 30806-86-1 | C14H16N4O4 |
|
| 5-(2R)-2-环氧乙烷基-8-苄氧基-2(1H)-喹啉酮 | 5-(2R)-2-oxiranyl-8-benzyloxy-2(1H)-quinolinone | 173140-90-4 | C18H15NO3 |
|
| 5-(2-溴-1-氧代丁基)-8-羟基-2(1H)-喹啉酮 | 5-(2-bromo-1-oxobutyl)-8-hydroycarbostyril | 59827-93-9 | C13H12BrNO3 |
|
| 5-(2-氯苄基)-噻吩并[3,2-c]吡啶鎓氯化物 | 5-(2-Chlorobenzyl)thieno(3,2-C)pyridinium chloride | 53885-64-6 | C14H11Cl2NS |
|
| 5-(2-氟苯基)-1H-吡咯-3-甲腈 | 5-(2-fluorophenyl)-1H-pyrrole-3-carbonitrile | 1240948-77-9 | C11H7FN2 |
|
| 5-(2-氟苯基)-1-[(吡啶-3-基)磺酰基]-1H-吡咯-3-甲醛 | 5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrole-3-carbaldehyde | 881677-11-8 | C16H11FN2O3S |
|
| 5-(2-(4-(苯并[d]异噻唑-3-基)哌嗪-1-基)乙基)-6-氯吲哚啉-2,3-二酮 | 3-Oxo ziprasidone | 1159977-56-6 | C21H19ClN4O2S |
|
| 5-(1-甲基-4-哌啶基)5H-二苯并[a,d]环庚烯-5-醇 | 5-(1-methyl-4-piperidyl)-5H-dibenzo<a,d>cyclohepten-5-ol | 3967-32-6 | C21H23NO |
|
| 5,7-二羟基-2-(4-羟基苯基)-6-[(2S,3S,4R,5R,6R)-3,4,5-三羟基-6-(羟基甲基)四氢吡喃-2-基]-8-[(2S,3S,4R,5S,6S)-3,4,5-三羟基-6-甲基-四氢吡喃-2-基]苯并吡喃-4-酮 | Violanthin | 40581-17-7 | C27H30O14 |
|
| 5,7-二氟苯并二氢吡喃-4-酮 | 5,7-difluorochroman-4-one | 844648-22-2 | C9H6F2O2 |
|
| 5,6-二甲氧基-2-(4-吡啶甲基)-1-茚酮/多萘哌齐杂质B | 5,6-dimethoxy-2-(pyridin-4-ylmethyl)-2,3-dihydro-1H-inden-1-one | 4803-57-0 | C17H17NO3 |
|
| 5,6-二氯-N-(4-(4-氯噻吩-2-基)-5-(4-环己基哌嗪-1-基)噻唑-2-基)烟酰胺 | 5,6-dichloro-N-[4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)-1,3-thiazol-2-yl]nicotinamide | 570403-04-2 | C23H24Cl3N5OS2 |
|
| 5,6-二氯-3,4-二氢-2(1H)-亚胺喹唑啉-3-乙酸乙酯氢溴酸盐 | ethyl-5,6-dichloro-3,4-dihydro-2-(1H)-iminoquinazoline-3-acetate hydrobromide | 70381-75-8 | BrH*C12H13Cl2N3O2 |
|
| 5,11-二氢-4-甲基-6H-二吡啶并[3,2-b:2',3'-e][1,4]二氮杂卓-6-酮 | 5,11-dihydro-4-methyl-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one | 287980-84-1 | C12H10N4O |
|
| 5,11-二氢-4-甲基-11-丙基-6H-二吡啶并[3,2-b:2',3'-e][1,4]二氮杂卓-6-酮 | Birg-613 BS | 287980-85-2 | C15H16N4O |
|
| 5'-脱氧吡哆辛 | 5'-Deoxypyridoxin | 4811-03-4 | C8H11NO2 |
|
| 5'-脱氧-5-氟-N-[(2-甲基丁氧基)羰基]胞苷 | 5'-deoxy-5-fluoro-N4-(2-methyl-1-butyloxycarbonyl)cytidine | 910129-15-6 | C15H22FN3O6 |
|
| 5'-脱氧- 5 -氟-N -[(3-甲基丁)羰基]胞苷 | 5'-deoxy-5-fluoro-N4-(3-methyl-1-butyloxycarbonyl)cytidine | 162204-30-0 | C15H22FN3O6 |
|
| 5'-去甲环氧长春碱 | nor-5' leurosine | 72311-64-9 | C45H54N4O9 |
|
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