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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L-脯氨酸甲酯 | L-Proline methyl ester | 2577-48-2 | C6H11NO2 |
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L-米那普仑氨甲酰-Β-D-葡糖苷酸 | Milnacipran carbamoyl o-glucuronide, L- | 1446438-98-7 | C22H30N2O9 |
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L-甲状腺素杂质44 | 3,5,3',5',-Tetraiod-thyromilchsaeure | 7069-47-8 | C15H10I4O5 |
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L-2-氨基丁酰胺 | (S)-2-amino-butanamide | 7324-11-0 | C4H10N2O |
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L-1-异丁酰基脯氨酸 | N-(2-methyl-1-oxopropyl)-L-proline | 23500-15-4 | C9H15NO3 |
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FAVIPIRAVIR杂质14 | 3-chloro-6-fluoro-2-pyrazinecarbonitrile | 356783-49-8 | C5HClFN3 |
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DELTA(3)-头孢替安 | delta(3)-Cefotiam | 142182-63-6 | C18H23N9O4S3 |
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D-青霉胺二硫化物 | D-Penicillamin-disulfid | 20902-45-8 | C10H20N2O4S2 |
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D-赤藓-3,4-二羟基苯基丝氨酸 | (2R,3R)-2-amino-3-(3,4-dihydroxyphenyl)-3-hydroxypropanoic acid | 51829-98-2 | C9H11NO5 |
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D-蔗糖酸钙四水合物 | D-Saccharic acid calcium salt tetrahydrate | 5793-88-4 | C6H16CaO12 |
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D-色氨酸甲酯 | D-Tryptophan methyl ester | 22032-65-1 | C12H14N2O2 |
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D-羟基苯甘氨酰阿莫西林 | (4-Hydroxyphenyl)glycylamoxicillin, D- | 188112-75-6 | C24H26N4O7S |
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D-生物素 | 5-((3aS,4S,6aR)-5-oxido-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl)pentanoic acid | 10406-89-0 | C10H16N2O4S |
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CEFTAROLINE中间体 | [4-(N-methylpyridinium-4-yl)-1,3-thiazol-2-yl]thiolate | 1427207-46-2 | C9H8N2S2 |
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CD 437; 6-[3-(1-金刚烷基)-4-羟基苯基]-2-萘甲酸 | CD437 | 125316-60-1 | C27H26O3 |
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CATESTATIN(人) | Catestatin | 197151-46-5 | C104H164N32O27S |
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C-去甲阿替洛尔 | Cis-Desmethyl Atenolol | 1797116-92-7 | C13H20N2O3 |
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BETA-D-吡喃葡萄糖醛酸1-[N-[(1R)-3-[5,6-二氢-3-(三氟甲基)-1,2,4-三唑并[4,3-A]吡嗪-7(8H)-基]-3-氧代-1-[(2,4,5-三氟苯基)甲基]丙基]氨基甲酸酯] | beta-D-Glucopyranuronic acid, 1-[N-[(1R)-3-[5,6-dihydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazin-7(8H)-yl]-3-oxo-1-[(2,4,5-trifluorophenyl)methyl]propyl]carbamate] | 940002-59-5 | C23H23F6N5O9 |
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BATA,BATA-二甲基丙烯酰紫草素 | 1'O-(β,β-dimethyl)acrylshikonin | 24502-79-2 | C21H22O6 |
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Alpha-甲酰基苯乙酸甲酯 | methyl 2-formyl-2-phenylacetate | 5894-79-1 | C10H10O3 |
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Alpha-溴甲基-2-氯苯甲醇 | 2-bromo-1-(2-chlorophenyl)ethanol | 72702-57-9 | C8H8BrClO |
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Alpha-(氯甲基)-2-羟基甲基-5-硝基咪唑-1-乙醇 | alpha-(Chloromethyl)-2-hydroxymethyl-5-nitroimidazole-1-ethanol | 62580-79-4 | C7H10ClN3O4 |
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Alpha-(氯甲基)-2,4-二氯苯甲醇 | 2-chloro-1-(2,4-dichlorophenyl)ethanol | 13692-14-3 | C8H7Cl3O |
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氨苄西林杂质G | (3R,6R)-3,6-bis(phenyl)piperazine-2,5-dione | 31485-02-6 | C16H14N2O2 |
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ALPHA-D-吡喃葡萄糖基O-4,6-二脱氧-4-[[(1S,4R,5S,6S)-4,5,6-三羟基-3-(羟基甲基)-2-环己烯-1-基]氨基]-ALPHA-D-吡喃葡萄糖基-(1-4)-O-ALPHA-D-吡喃葡萄糖基-(1-4)-ALPHA-D-吡喃葡萄糖苷 | Acarbose EP Impurity G | 1013621-73-2 | C31H53NO23 |
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?9,11-去氢-17alpha-氰基甲基雌二醇 | 17α-Cyanomethylestra-1,3,5(10),9(11)-tetraen-3,17β-diol | 86153-38-0 | C20H23NO2 |
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9-(2,5-d|二氧-L-3-氨基-1-吡咯烷乙酸)-10-脱甘氨酸达托霉素 | Daptomycin, 9-(2,5-dioxo-L-3-amino-1-pyrrolidineacetic acid)-10-deglycine- | 121869-35-0 | C72H99N17O25 |
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9-甲氧基甲基鸟嘌呤 | methoxymethylguanine | 1202645-50-8 | C7H9N5O2 |
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9-甲氧基-1,3-二甲基-12-硫氧代吡啶并[1’,2’:3,4]咪唑并-[1,2-a]苯并咪唑-2(12H)-酮 | 8-methoxy-2,4-dimethyl-5-thioxo-5-hydro-pyrido<1',2':3,4>imidazo<1,2-a>benzimidazol-3-one | 125656-83-9 | C16H13N3O2S |
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9-氯-2-甲基-5H-吡唑并[1,5-D][1,4]苯并二氮杂卓-6(7H)-酮 | 8-Chloro-2-methyl-6H-3,3a,6-triaza-benzo[e]azulen-5-one | 84661-23-4 | C12H10ClN3O |
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9-氟-3-甲基-10-(4-甲基-4-氧代-1-哌嗪基)-7-氧代-2,3-二氢-7H-[1,4]恶嗪并[2,3,4-Ij]喹啉-6-羧酸乙酸盐(1:1) | 4-[6-carboxy-9-fluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de]-1,4-benzoxazin-10-yl]-1-methylpiperazine 1-oxide | 104721-52-0 | C18H20FN3O5 |
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9-去氯-9-溴倍氯米松二丙酸酯 | 9α-bromo-11β,17α,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate | 52092-14-5 | C28H37BrO7 |
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9-去氟-9(11)-环氧曲安奈德 | (1S,3S,5S,6S,10R,12S,13S,21S)-6-(2-hydroxyacetyl)-5,8,8,21-tetramethyl-2,7,9-trioxahexacyclo[11.8.0.01,3.05,12.06,10.016,21]henicosa-16,19-dien-18-one | 39672-75-8 | C24H30O6 |
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9-亚甲基芴 | 9-methylene-fluorene | 4425-82-5 | C14H10 |
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9-[[2-(alpha-L-丙氨酰氧基)乙氧基]甲基]鸟嘌呤盐酸盐 | 9-[[2-(alpha-L-Alanyloxy)ethoxy]methyl]guanine Hydrochloride | 84499-63-8 | C11H17ClN6O4 |
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9-(2-羟基乙基)鸟嘌呤 | 9-(2-hydroxyethyl)guanine | 23169-33-7 | C7H9N5O2 |
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9-(2-羟乙基)腺嘌呤 | 9-(2-hydroxyethyl)adenine | 707-99-3 | C7H9N5O |
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9-(2-丙烯基)腺嘌呤 | 9-allyl-9H-adenine | 4121-39-5 | C8H9N5 |
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8-表阿扎那韦 | 1-[4-(pyridin-2-yl)phenyl]-2,5-bis{[N-(methoxycarbonyl)-L-tert-leucinyl]amino}-4(S)-hydroxy-6-phenyl-2-azahexane | 1292296-09-3 | C38H52N6O7 |
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8-脱氯-9-氯氯雷他定 | loratadine | 109537-11-3 | C22H23ClN2O2 |
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8-脱氯-9-氯地氯雷他定 | desloratadine | 117811-13-9 | C19H19ClN2 |
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8-羟基甲基核黄素 | 8-Hydroxymethylriboflavin | 52134-62-0 | C17H20N4O7 |
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8-羟基松脂醇二葡萄糖苷 | (+)-1-hydroxypinoresinol 4',4"-di-O-β-D-glucopyranoside | 112747-99-6 | C32H42O17 |
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8-羟基-2-氧代-1,2-二氢-5-喹啉甲醛 | 5-formyl-8-hydroxycarbostyryl | 68304-21-2 | C10H7NO3 |
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8-甲氧基喹啉-2-酮 | 8-methoxyquinolin-2(1H)-one | 22614-69-3 | C10H9NO2 |
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8-溴茶碱 | 8-bromotheophylline | 10381-75-6 | C7H7BrN4O2 |
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8-氯-6-(2-氟苯基)-1-甲基-4H-咪唑并[1,5-a][1,4]苯并二氮杂卓-3-羧酸 | 8-Chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine-3-carboxylic acid | 59468-44-9 | C19H13ClFN3O2 |
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8-氯-6,11-二氢-11-(1-甲基-4-哌啶基)-5H-苯并[5,6]环庚烷[1,2-b]吡啶-11-醇 | 8-chloro-6,11-dihydro-11-(1-methyl-4-piperidinyl)-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ol | 38089-93-9 | C20H23ClN2O |
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8-氯-6,11-二氢-11-(1-甲基-4-哌啶叉)-5H-苯并[5,6]环庚烷[1,2-b]吡啶 | N-methyldesloratadine | 38092-89-6 | C20H21ClN2 |
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8-氯-5,6-二氢-5-甲基-6-氧代-4H-咪唑并[1,5-a][1,4]苯并二氮杂卓-3-羧酸乙酯 | ethyl 8-chloro-5-methyl-6-oxo-5,6-dihydro-4H-imidazo[1,5-a][1,4]benzodiazepine-3-carboxylate | 78756-33-9 | C15H14ClN3O3 |
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