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 |
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2-乙基己基吡喃葡萄糖苷 | 2-ethyl-hexyl α-D-glucopyranoside | 125590-73-0 | C14H28O6 |
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2-乙基-2-甲基丁二酸 | 2-ethyl-2-methylsuccinic acid | 631-31-2 | C7H12O4 |
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2-丙酰苯甲酸 | 2-propanoylbenzoic acid | 2360-45-4 | C10H10O3 |
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2-丁基-3-(4-羟基苯甲酰基)苯并呋喃 | (2-butylbenzofuran-3-yl)(4-hydroxyphenyl)methanone | 52490-15-0 | C19H18O3 |
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2-丁基-3-(3,5-二碘-4-羟基苯甲酰)苯并呋喃 | 2-n-butyl-3-(3',5'-diiodo-4'-hydroxybenzoyl)benzofuran | 1951-26-4 | C19H16I2O3 |
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2-丁基-1,6-二氢-N,N,4-三甲基-6-氧代-1-[[2'-[1-(三苯甲基)-1H-四氮唑-5-基][1,1'-联苯]-4-基]甲基]-5-嘧啶乙酰胺 | 2-butyl-5-dimethylaminocarbonylmethyl-6-methyl-3-[[2’-(N-trityl-5-tetrazolyl)-4-biphenylyl]methyl]-4-pyrimidinone | 503155-67-7 | C46H45N7O2 |
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2-n-丙基-4-甲基-6-(1-苯并咪唑-2-基)苯并咪唑 | desmethyl dibenzimidazole | 884330-09-0 | C18H18N4 |
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2-[[[3-甲基-4-(2,2,2三氟乙氧基)-2-吡啶]-甲基]硫基]-1H-苯并咪唑 | lansoprazole sulfide | 103577-40-8 | C16H14F3N3OS |
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2-[[4-[(2-氨基-4-氧代-1H-蝶啶-6-基)甲基-甲基氨基]苯甲酰基]氨基]戊烷二酸 | 10-methylfolic acid | 2410-93-7 | C20H21N7O6 |
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2-[[3-[[4-[(3-氯-4-氟苯基)氨基]-7-甲氧基-6-喹唑啉yl]氧基]丙基]氨基]乙醇 | 3-Desmorpholinyl-3-hydroxyethylamino Gefitinib | 847949-56-8 | C20H22ClFN4O3 |
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2-[[3-[2-(二甲基氨基)乙基]-1H-吲哚-5-基]甲基]舒马普坦 | [[3-[2-(dimethylamino)ethyl]-2-[[3-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-1H-indol-5-yl]-N-methylmethanesulfonamide | 545338-89-4 | C27H37N5O2S |
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2-[[2-[(4-羟基苯基)磺酰基氨基]苯甲酰基]氨基]乙酸 | (2-(4-hydroxy-benzenesulfonylamino)-benzoylamino)-acetic acid | 155023-59-9 | C15H14N2O6S |
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2-[[(6-甲氧基-1H-苯并咪唑-2-基)亚磺酰基]甲基]-3,5-二甲基-4-吡啶醇 | 4-Hydroxy omeprazole | 301669-82-9 | C16H17N3O3S |
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2-[[(4-甲氧基-3-甲基-2-吡啶基)甲基]亚磺酰基]-1H-苯并咪唑 | 2-[(RS)-[(4-methoxy-3-methylpyridin-2-yl)methyl]sulfinyl]-1H-benzimidazole | 102804-77-3 | C15H15N3O2S |
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2-[[(3aR,4S,6R,6aS)-6-[7-氯-5-(丙硫基)-3H-1,2,3-三氮唑并[4,5-d]嘧啶-3-基]四氢-2,2-二甲基-4H-环戊烯并-1,3-二恶茂-4-基]氧基]乙醇 | 2-(((3aR,4S,6R,6aS)-6-(7-chloro-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-2,2-dimethyltetrahydro-3aH-cyclopenta[d][1,3]dioxol-4-yl)oxy)ethanol | 376608-75-2 | C17H24ClN5O4S |
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2-[[((2S)-2-氨基-3-苯基丙基]氨基]-3-甲基-5-(2-萘基)-6-(4-吡啶基)-4(3H)-嘧啶酮 | AMG-548 | 864249-60-5 | C29H27N5O |
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2-[4-氨基磺酰-苯基]-乙基-5-甲基吡嗪甲酰胺 | 5-methyl-N-(4-sulfamoylphenethyl)pyrazine-2-carboxamide | 33288-71-0 | C14H16N4O3S |
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2-[4-[(1E)-1,2-二苯乙烯基]苯氧基]-N,N-二甲基乙胺 | cis-1,2-diphenyl-1-<4-(2-dimethylaminoethoxy)phenyl>ethylene | 97151-10-5 | C24H25NO |
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2-[4-(3-氯-2-羟基丙氧基)苯基]乙酰胺 | 1-<p-(carbamoylmethyl)phenoxy>-3-chloropropan-2-ol | 115538-83-5 | C11H14ClNO3 |
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2-[4-(2,3-二羟基丙氧基)苯基]乙酰胺 | 2-(4-(2,3-Dihydroxypropoxy)phenyl)acetamide | 61698-76-8 | C11H15NO4 |
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2-[3-(氯甲基)-5-(2-氰基丙烷-2-基)苯基]-2-甲基丙腈 | 2,2'-(5-chloromethyl-1,3-phenylene)di(2-methylpropiononitrile) | 120511-91-3 | C15H17ClN2 |
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2-[3-(2-氰基丙烷-2-基)-5-(1,5-二氢-1,2,4-三唑-4-基甲基)苯基]-2-甲基丙腈 | α,α,α',α'-tetramethyl-5-(4H-1,2,4-triazol-4ylmethyl)-1,3-benzene-diacetonitrile | 120511-92-4 | C17H19N5 |
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2-[2-[3(S)-[3-(7-氯-2-喹啉基)乙烯基]苯基]-3-羟基丙基]苯基-2-丙醇 | (S,E)-1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propan-1-ol | 287930-77-2 | C29H28ClNO2 |
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2-[2-(2-甲氧基苯氧基)乙基]-1H-异吲哚-1,3(2H)-二酮 | N-(o-methoxyphenoxyethyl)-phthalimide | 26646-63-9 | C17H15NO4 |
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2-[2-(2-甲基-4-硝基-1H-咪唑-1-基)乙氧基]乙醇 | 2-[2-(2-methyl-4-nitro-imidazol-1-yl)-ethoxy]-ethanol | 19765-12-9 | C8H13N3O4 |
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2-[2-(2-氨基-9h-嘌呤-9-基)乙基]-1,3-丙二醇 | 6-deoxypenciclovir | 104227-86-3 | C10H15N5O2 |
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2-[1-(2-氟苄基)-1H-吡唑并[3,4-b]吡啶-3-基]嘧啶-4,5,6-三胺 | 2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)pyrimidine-4,5,6- triamine | 428854-24-4 | C17H15FN8 |
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2-[(4-羧甲基苯氧基)甲基]苯甲酸 | 4-(2-carboxybenzyloxy) phenyl acetic acid | 55453-89-9 | C16H14O5 |
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2-[(4-羟基苯基)-2-吡啶基甲基]苯酚 | 2,4'-(2-pyridinmethylene)-bisphenol | 16985-05-0 | C18H15NO2 |
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2-[(4-甲氧基-3-甲基吡啶-2-基)甲硫基]-1H-苯并咪唑 | 2-[[(4-methoxy-3-methylpyridin-2-yl)methyl]mercapto]-1H-benzimidazole | 102804-82-0 | C15H15N3OS |
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2-[(4-甲基苯氧基)甲基]苯甲酸 | 2-[(4-methylphenoxy)methyl]benzoic acid | 728-97-2 | C15H14O3 |
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2-[(3R,5R)-3,5-二[[(叔丁基)二甲基硅烷基]氧基]环己基亚基]乙醇 | 2-[(3R,5R)-3,5-bis(tert-butyldimethylsilanyloxy)cyclohexylidene]ethanol | 139356-37-9 | C20H42O3Si2 |
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2-[(2R)-2-羟基-3-[[4-(3-氧代-4-吗啉)苯基]氨基]丙基]-1H-异吲哚-1,3(2H)-二酮 | 2-((2R)-2-hydroxy-3-{[4-(3-oxo-4-morpholinyl)phenyl]amino}propyl)-1H-isoindole-1,3(2H)-dione | 446292-07-5 | C21H21N3O5 |
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2-[(2-叠氮基乙氧基)甲基]-4-(2-氯苯基)-3-乙氧羰基-5-甲氧羰基)-6-甲基-1,4-二氢吡啶 | 3-ethyl 5-methyl 2-((2-azidoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate | 88150-46-3 | C20H23ClN4O5 |
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2-[(1S,2S)-1-乙基-2-苄氧基丙基]-2,4-二氢-4-[4-[4-(4-羟基苯基)-1-哌嗪基]苯基]-3H-1,2,4-三氮唑-3-酮 | 1-((2S,3S)-2-(benzyloxy)pentan-3-yl)-4-(4-(4-(4-hydroxyphenyl)piperazin-1-yl)phenyl)-1H-1,2,4-triazol-5(4H)-one | 184177-83-1 | C30H35N5O3 |
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2-[(1-苄基-4-哌啶基)亚甲基]-5,6-二甲氧基-1-茚满酮 | (E)-2-((1-benzylpiperidin-4-yl)methylene)-5,6-dimethoxy-2,3-dihydro-1H-inden-1-one | 120014-07-5 | C24H27NO3 |
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2-[(1,1-二甲基乙基)氨基]-1-[4-OH-3-(羟甲基)苯基]乙烷-1-酮 | salbutamol ketone | 156547-62-5 | C13H19NO3 |
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2-(苄基甲基氨基)-3',4'-二羟基苯乙酮 | 2-(benzyl-methyl-amino)-1-(3,4-dihydroxy-phenyl)-ethanone | 36467-25-1 | C16H17NO3 |
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2-(甲基氨基甲酰基)苯甲酸 | 2-(methylcarbamoyl)benzoic acid | 6843-36-3 | C9H9NO3 |
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2-(氰基甲硫基)乙酸 | 2-(Cyanomethylthio)acetic acid | 55817-29-3 | C4H5NO2S |
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2-(氨基羰基)苯甲酸甲酯 | methyl 2-carbamoylbenzoate | 90564-02-6 | C9H9NO3 |
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2-(六氢-1-甲基-1H-氮杂革-4-基)肼苯甲酸 | N'-(1-Methylazepan-4-yl)benzohydrazide | 110406-94-5 | C14H21N3O |
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2-(二苯甲基氧基)-n-甲基乙胺盐酸盐 | 2-(Benzhydryloxy)-N-methylethanamine hydrochloride | 53499-40-4 | C16H20ClNO |
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2-(二甲氨基)-N-(2,6-二甲基苯基)乙酰胺 | W 36017 | 21236-54-4 | C12H18N2O |
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2-(二甲基氨基甲酰基)苯甲酸 | 2-(dimethylaminocarbonyl)benzoic acid | 20320-37-0 | C10H11NO3 |
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2-(二溴甲基)苯甲腈 | 2-(dibromomethyl)benzonitrile | 655-63-0 | C8H5Br2N |
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2-(二乙氨基)-N-(3,4-二甲基苯基)乙酰胺 | 2-(diethylamino)-N-(3,4-dimethyl-phenyl)acetamide | 3213-16-9 | C14H22N2O |
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2-(二乙氨基)-N-(2,5-二甲基苯基)乙酰胺 | 2-(diethylamino)-N-(2,5-dimethyl-phenyl)acetamide | 857570-37-7 | C14H22N2O |
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2-(二乙氨基)-N-(2,4-二甲基苯基)乙酰胺 | 2-(diethylamino)-N-(2,4-dimethyl-phenyl)acetamide | 17289-53-1 | C14H22N2O |
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2-(二乙氨基)-N-(2,3-二甲基苯基)乙酰胺 | 2-(diethylamino)-N-(2,3-dimethyl-phenyl)acetamide | 142713-08-4 | C14H22N2O |
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