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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alpha-D-半乳糖 | α-D-galactopyranose | 3646-73-9 | C6H12O6 |
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alpha-(4-氯苯基)-alpha-[2-(二甲基氨基)乙基]吡啶-2-乙腈 | chloropheniramine nitrile | 65676-21-3 | C17H18ClN3 |
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alpha-(2,4-二氯苯基)-1H-咪唑-1-乙醇 | 1-(2,4-dichlorophenyl)-2-(1H-imidazol-1-yl)ethan-1-ol | 24155-42-8 | C11H10Cl2N2O |
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alpha,beta-去氢洛伐他汀 | dehydromonacolin K | 109273-98-5 | C24H34O4 |
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[乙氧基(羟基)磷酰基]甲酸 | Disodium (ethoxyoxydophosphanyl)formate | 55920-24-6 | C3H5Na2O5P |
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[[4-[[2-(1-甲基乙氧基)乙氧基]甲基]苯氧基]甲基]环氧乙烷 | 2-((4-((2-isopropoxyethoxy)methyl)phenoxy)methyl)oxirane | 66722-57-4 | C15H22O4 |
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[[4-[2-[[(3-乙基-2,5-二氢-4-甲基-2-氧代-1H-吡咯-1-基)羰基]氨基]乙基]苯基]磺酰基]氨基甲酸甲酯 | Glimepiride urethane | 119018-30-3 | C18H23N3O6S |
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[[4-[2-[(5-氯-2-甲氧基苯甲酰基)氨基]乙基]苯基]磺酰基]氨基甲酸甲酯 | Methyl-4-<β-(2-methoxy-5-chlorbenzamido)ethyl>-phenylsulfonyl-carbamat | 21165-77-5 | C18H19ClN2O6S |
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[[4-[(3-甲基苯基)氨基]-3-吡啶基]磺酰基]氨基甲酸乙酯 | Ethyl {4-[3-(hydroxymethyl)anilino]pyridine-3-sulfonyl}carbamate | 72810-57-2 | C15H17N3O5S |
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[[(2R,3S,4R,5R)-5-(2,4-二氧代嘧啶-1-基)-3,4-二羟基四氢呋喃-2-基]甲氧基-羟基磷酰][(2R,3R,4R,5R,6S)-3,4,5-三羟基-6-甲基四氢吡喃-2-基]磷酸氢酯 | diphosphoric acid-1-β-L-rhamnopyranosyl ester-2-uridin-5'-yl ester | 1955-26-6 | C15H24N2O16P2 |
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[[(1a,3b,5E,7E,22E)-9,10-开环麦角甾-5,7,10(19),22-四烯-1,3-基]双(氧)]双[(1,1-二甲基乙基)二甲基硅烷] | 1(S),3(R)-bis(tert-butyldimethylsilyloxy)-9,10-secoergosta-5(E),7(E),10(19),22(E)-tetraene | 115540-28-8 | C40H72O2Si2 |
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[S-(R*,R*)]-3,3'-亚二硫基二[2-甲基丙酸] | (-)-2,2'-dimethyl-3,3'-dithiobispropionic acid | 65134-74-9 | C8H14O4S2 |
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[R-(R*,R*)]-酒石酸单乙酯 | (R,R)-tartaric acid ethyl ester | 608-89-9 | C6H10O6 |
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[R(r*,r*]-2-氨基-1-[p-(甲基磺酰基)苯基]-1,3-丙二醇 | (1R,2R)-2-amino-1-(4-(methylsulfonyl)phenyl)propane-1,3-diol | 51458-28-7 | C10H15NO4S |
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[N-[2-羟基-5-[1-羟基-2-[2-(4-甲氧苯基)-1-甲基乙基氨基]乙基]苯基]甲酰胺]富马酸盐二水合物 | Oxeze | 183814-30-4 | C42H56N4O14 |
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[4-[4-(4-羟基苯基)-1-哌嗪基]苯基]氨基甲酸苯酯 | phenyl (4-(4-(4-hydroxyphenyl)piperazin-1-yl)phenyl)carbamate | 184177-81-9 | C23H23N3O3 |
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[4-(4-甲基-1-哌嗪基)-10H-噻吩并[2,3-b][1,5]苯并二氮杂卓-2-基]甲醇 | 2-hydroxymethylolanzapine | 174756-45-7 | C17H20N4OS |
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[4-(4-氨基-7-羟基-6-甲氧基-2-喹唑啉基)-1-哌嗪基](四氢-2-呋喃基)甲酮 | 7-O-Desmethyl terazosin | 105356-90-9 | C18H23N5O4 |
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[3-(9H-咔唑-4-基氧基)-2-羟基]丙基卡维地洛 | 1-(9H-Carbazol-4-yloxy)-3-(4-(2-hydroxy-3-((2-(2-methoxyphenoxy)ethyl)amino)propoxy)-9H-carbazol-9-yl)propan-2-ol | 1391052-16-6 | C39H39N3O6 |
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[2S-(2alpha,5alpha,6alpha)]-6-溴-3,3-二甲基-7-氧代-4-硫杂-1-氮杂双环[3.2.0]庚烷-2-羧酸 | 6-bromopenicillanic acid | 24138-28-1 | C8H10BrNO3S |
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[2R-[2aR*),3a]-2-[1-[3,5-双(三氟甲基)苯基]乙氧基]-3-(4-氟苯基)吗啉 | (2R,3R)-2-[(1S)-1-(3,5-bis-trifluoro-methylphenyl)ethoxy]-3-(4-fluorophenyl)morpholine | 170729-79-0 | C20H18F7NO2 |
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[2-氨基-3-羟基-2-(羟甲基)丙基]磷酸二氢盐 | [2-amino-3-hydroxy-2-(hydroxymethyl)propoxy]phosphonic acid | 23001-39-0 | C4H12NO6P |
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[2-[4-(氨基磺酰基)苯基]乙基]氨基甲酸乙酯 | Ethyl (2-(4-sulfamoylphenyl)ethyl)carbamate | 192118-08-4 | C11H16N2O4S |
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[2-[(8S,9S,10R,11S,13S,14S)-11-羟基-10,13-二甲基-3-氧代-6,7,8,9,11,12,14,15-八氢环戊烯并[a]菲-17-基]-2-氧代乙基]乙酸酯 | 17a-prednisolone dehydroxyacetate | 3044-42-6 | C23H28O5 |
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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]乙基]二苯基氧膦 | (1R,3R)-1,3-bis((tert-butyldimethyl)silanyloxy)-5-[2-(diphenylphosphinoyl)-ethylidene]cyclohexane | 139356-39-1 | C32H51O3PSi2 |
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[2-[(2-氨基-4-氯苯基)氨基]苯基](4-甲基-1-哌嗪基)甲酮 | 2-amino-4-chlorodiphenylamine-2'-carboxylic acid (4''-methyl)piperazide | 65514-71-8 | C18H21ClN4O |
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[2-(4-氟苯基)环丙基]胺盐酸盐 | 2‐(4‐fluorophenyl)cyclopropylamine hydrochloride | 879324-66-0 | C9H10FN*ClH |
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[2,2'-联萘]-6,6'-二甲酸 | 2,2'-binaphthalene-6,6'-dicarboxylic acid | 932033-58-4 | C22H14O4 |
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[1S-(1α,3a&#x3B2,4α,8a&#x3B2,9S*)]-十氢-4,8,8-三甲基-1,4-亚甲基薁-9-甲醇 | [S,E]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]-cyclopropane acetic acid sodium salt | 190078-45-6 | C35H35ClNO3S*Na |
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[1R-[1alpha,(1R*,2E,4S*),3abeta,7aalpha]]-八氢-1-(5-羟基-1,4,5-三甲基-2-己烯基)-7a-甲基-4H-茚-4-酮 | <1R<1β(R<sup>*</sup>,E,S),3aα,7aβ>>-6-(Octahydro-7a-methyl-1H-4-oxoinden-1-yl)-2,3-dimethyl-4-hepten-2-ol | 95716-68-0 | C19H32O2 |
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[1-[4-[[(4-氟苄基)氨基]羰基]-5-羟基-1-甲基-6-氧代-1,6-二氢嘧啶-2-基]-1-甲基乙基]氨基甲酸苄酯 | benzyl (2-(4-((4-fluorobenzyl)carbamoyl)-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidin-2-yl)propan-2-yl)carbamate | 518048-02-7 | C24H25FN4O5 |
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[1,4'-联哌啶]-1'-羧酸 | 1,4'-bipiperidine-1'-carboxylic acid | 1026078-50-1 | C11H20N2O2 |
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[1,1-双环己基]-1-羧酸 | 1-cyclohexylcyclohexane-1-carboxylic acid | 60263-54-9 | C13H22O2 |
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[(4R,6R)-6-(氰基甲基)-2,2-二甲基-1,3-二恶烷-4-基]乙酸 | [(4R,6R)-6-(Cyanomethyl)-2,2-dimethyl-1,3-dioxan-4-yl]acetic acid | 807312-27-2 | C10H15NO4 |
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[(4-氨基-2-甲基-5-嘧啶)甲基]二硫代氨基甲酸盐(或酯) | 1-[2-(Acetoxy)ethyl]-2-oxopropyl [(4-amino-2-methyl-5-pyrimidinyl)methyl]dithiocarbamate | 89285-03-0 | C14H20N4O3S2 |
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[(3S,4R)-1-苄基-4-(4-氟苯基)-3-哌啶基]甲醇 | (3S,4R)-[1-benzyl-4-piperidin-3-yl-4-(4-fluorophenyl)]methanol | 201855-60-9 | C19H22FNO |
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[(3R)-1-[7-(2-丁炔基)-2,3,6,7-四氢-3-甲基-2,6-二氧代-1H-嘌呤-8-基]-3-哌啶基]氨基甲酸叔丁酯 | 3-methyl-7-(2-butyn-1-yl)-8-[(R)-3-(tert-butoxycarbonylamino)piperidin-1-yl]xanthine | 666816-91-7 | C20H28N6O4 |
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[(2S,4S)-4-[4-(3-甲基-1-苯基-1H-吡唑-5-基)-1-哌嗪基]-2-吡咯烷基]-3-噻唑烷基甲酮氢溴酸盐水合物(2:5:) | Teneligliptin hydrobromide hydrate | 1572583-29-9 | C44H67Br5N12O3S2 |
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[(2,3-二氢-1,5-二甲基-3-氧代-2-苯基的1H-吡唑-4-基)氨基]甲磺酸 | Sulfamidopyrine | 117-38-4 | C12H15N3O4S |
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[(2,2-二甲基丙烷酰基)氧基]甲基6-氨基-3,3-二甲基-7-氧代-4-硫杂-1-氮杂双环[3.2.0]庚烷-2-羧酸酯 | (pivaloyloxy)methyl 6β-aminopenicillate | 25031-08-7 | C14H22N2O5S |
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[(1S,4R)-4-(2-氨基-6-氯-9H-嘌呤-9-基)-2-环戊烯]甲醇盐酸盐 | (1S,cis)-4-(2-amino-6-chloro-9-H-purin-9-yl)-2-cyclopentene-1-methanol hydrochloride | 172015-79-1 | C11H12ClN5O*ClH |
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[(1R,2S,5S)-2-[[2-[(5-氯吡啶-2-基)氨基]-2-氧代乙酰基]氨基]-5-(二甲基氨基羰基)环己基]氨基甲酸叔丁酯 | tert-butyl [(1R,2S,5S)-2-({[(5-chloropyridin-2-yl)amino](oxo)acetyl}amino)-5-(dimethylaminocarbonyl)cyclohexyl]carbamate | 480452-36-6 | C21H30ClN5O5 |
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[(1R)-2-(联苯-4-基)-1-甲酰基乙基]氨基甲酸叔丁酯 | (R)-α-<<(1,1-dimethylethoxy)carbonyl>amino><1,1'-biphenyl>-4-propanal | 149709-58-0 | C20H23NO3 |
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Z-双羟萘酸噻嘧啶 | 1-methyl-2-[(Z)-2-thiophen-2-ylethenyl]-5,6-dihydro-4H-pyrimidine | 36700-38-6 | C11H14N2S |
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Z-2-丁烯二酸单十八酯 | (Z)-but-2-enedioic acid monooctadecyl ester | 2424-62-6 | C22H40O4 |
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USP杂质B | fluconazole | 81886-51-3 | C13H13FN6O |
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多索茶碱杂质10 | Theophyllidine Hydrochloride | 116131-08-9 | C6H11ClN4O |
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TAS-102杂质 | 5-carboxy-2'-deoxyuridine | 14599-46-3 | C10H12N2O7 |
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S-氨氯地平 | levamlodipine besylate | 150566-71-5 | C6H6O3S*C20H25ClN2O5 |
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S-3-羟基哌啶 | (S)-piperidin-3-ol | 24211-55-0 | C5H11NO |
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