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 |
|---|---|---|---|---|
| 6-(2,3-二氯苯基)-1,2,4-三嗪-3,5(2H,4H)-二酮 | 6-(2,3-Dichlorophenyl)-1,2,4-triazine-3,5(2H,4H)-dione | 661463-79-2 | C9H5Cl2N3O2 |
|
| 6,8-二甲氧基莫西沙星盐酸盐 | 1-cyclopropyl-6,8-dimethoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridine-6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid | 1029364-73-5 | C22H27N3O5 |
|
| 6,8-二氟-1,4-二氢-1-[(1S)-2-羟基-1-甲基乙基]-7-(4-甲基-1-哌嗪基)-4-氧代-3-喹啉羧酸 | (S)-6,8-difluoro-1-(1-hydroxypropan-2-yl)-7-(4-methylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid | 1036016-10-0 | C18H21F2N3O4 |
|
| 6,7-二甲氧基-4-(4-硝基-苯氧基)-喹啉 | 6,7-dimethoxy-4-(4-nitrophenoxy)quinoline | 190728-24-6 | C17H14N2O5 |
|
| 6,7-二甲基核糖基2,4-二羟基蝶啶 | 6,7-dimethyl-8-ribityllumazine | 2535-20-8 | C13H18N4O6 |
|
| 6,6二硫代双嘌呤 | bis(6-purinyl) disulfide | 49808-20-0 | C10H6N8S2 |
|
| 6,6'-二甲氧基-2,2'-联萘 | 6,6'-dimethoxy-2,2'-binaphthalene | 29619-45-2 | C22H18O2 |
|
| 6,11-二氢二苯并[b,e]氧杂卓-11-酮 | 6,11-dihydrodibenz[b,e]oxepin-11-one | 4504-87-4 | C14H10O2 |
|
| 6,11-二-O-甲基红霉素 | Clarithromycin Impurity E | 81103-14-2 | C39H71NO13 |
|
| 6(S)-氢过氧基辛伐他汀 | 6(S)-hydroperoxysimvastatin | 149949-01-9 | C25H38O7 |
|
| 5’-表拉米夫定 | (+)-(2R,5R)-1-<2-(hydroxymethyl)-1,3-oxathiolan-5-yl>cytosine | 139757-68-9 | C8H11N3O3S |
|
| 5’(S)-羟基辛伐他汀 | 2,2-Dimethyl-butyric acid (1S,3R,4S,7S,8S)-4-hydroxy-8-[2-((2R,4R)-4-hydroxy-6-oxo-tetrahydro-pyran-2-yl)-ethyl]-3,7-dimethyl-1,2,3,4,7,8-hexahydro-naphthalen-1-yl ester | 149949-05-3 | C25H38O6 |
|
| 5H-苯并[5,6]环庚烷并[1,2-B]吡啶-3-醇,8-氯-6,11-二氢-11-(4-哌啶基IDENE) | 3-Hydroxydesloratadine | 119410-08-1 | C19H19ClN2O |
|
| 5H-二苯并[a,d]环庚烯 | suberene | 256-81-5 | C15H12 |
|
| 5-雄甾-3-烯-17-酮 | 5α-androst-3-en-17-one | 14935-81-0 | C19H28O |
|
| 5-表恩曲他滨 | (+)-(2R,5R)-5-fluoro-1-<2-(hydroxymethyl)-1,3-oxathiolan-5-yl>cytosine | 145986-26-1 | C8H10FN3O3S |
|
| 5-苯硫基-1H-苯并咪唑-2-胺 | 5-propylthio-1H-benzimidazol-2-amine | 80983-36-4 | C10H13N3S |
|
| 5-苄氧基-2-(4-苄氧基-苯基)-3-甲基-1-[4-(2-氮杂环庚烷-1-基-乙氧基)-苄基]-1H-吲哚 | 5-benzyloxy-2-(4-benzyloxy-phenyl)-3-methyl-1-[4-(2-azepan-1-yl-ethoxy)-benzyl]-1H-indole | 198480-21-6 | C44H46N2O3 |
|
| 5-苄基-3，6-二氧-2-哌嗪乙酸 | cyclo(Asp-Phe) | 5262-10-2 | C13H14N2O4 |
|
| 5-羟基甲基氟氯西林 | 5-Hydroxymethylflucloxacillin | 75524-31-1 | C19H17ClFN3O6S |
|
| 5-羟基地氯雷他定 | 8-chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-5-ol | 117811-12-8 | C19H19ClN2O |
|
| 5-羟基兰索拉唑 | 5-Hydroxylansoprazole | 131926-98-2 | C16H14F3N3O3S |
|
| 5-羟基-6-甲氧基-1-茚满酮 | 5-hydroxy-6-methoxy-2,3-dihydro-1H-inden-1-one | 127399-78-4 | C10H10O3 |
|
| 5-硝基糠醛二乙酸酯 | 5-nitro-2-furfuraldehyde diacetate | 92-55-7 | C9H9NO7 |
|
| 5-硝基-1H-咪唑-1-乙醇 | 1-(2'-Hydroxyethyl)-5-nitroimidazol | 5006-68-8 | C5H7N3O3 |
|
| 5-甲氧基-2-苯并咪唑啉酮 | 5-methoxy-1H-benzo[d]imidazol-2(3H)-one | 2080-75-3 | C8H8N2O2 |
|
| 5-甲氧基-2-{[(4-氯-3,5-二甲基-吡啶-2-基)甲基]硫代}-1H-苯并咪唑 | 5-methoxy-2-[(4-chloro-3,5-dimethyl-2-pyridyl)methylsulfanyl]-1H-benzimidazole | 220757-74-4 | C16H16ClN3OS |
|
| 5-甲氧基-2-[[(4-甲氧基-3,5-二甲基-2-吡啶基)甲基]硫代]-1H-苯并咪唑N-氧化物 | 5-methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl-1-oxide)methyl]sulfanyl]-1H-benzimidazole | 142885-92-5 | C17H19N3O3S |
|
| 5-甲氧基-2-[[(4-甲氧基-3,5-二甲基-2-吡啶基)甲基]亚磺酰基]-1-甲基-1H-苯并咪唑 | N-Methyl omeprazole | 89352-76-1 | C18H21N3O3S |
|
| 5-甲氧基-2-[(4-甲氧基-3,5-二甲基-2-吡啶基)-甲基]-3H-苯并咪唑钠盐 | r-Omeprazole | 161796-77-6 | C17H19N3NaO3S |
|
| 5-甲氧基-2-(甲基硫代)苯并咪唑 | 5-methoxy-2-methylthio-1H-benzimidazole | 91168-31-9 | C9H10N2OS |
|
| 5-甲基-3-苯基-4-异恶唑甲酸 | 5-methyl-3-phenylisoxazol-4-carboxylic acid | 1136-45-4 | C11H9NO3 |
|
| 5-甲基-2-吡嗪羧酸1-氧化物 | acipimox | 98502-96-6 | C6H6N2O3 |
|
| 5-甲基-2-(1H-1,2,3-噻唑-1-基)苯甲酸 | 5-methyl-2-(1H-1,2,3-triazol-1-yl)benzoic acid | 1149352-55-5 | C10H9N3O2 |
|
| 5-烯普瑞巴林 | Unii-5X5D38P14P | 1141362-94-8 | C8H15NO2 |
|
| 5-溴甲基-a,a,a',a'-四甲基-1,3-二乙氰基苯 | 2-[3-bromomethyl-5-(cyanodimethylmethyl)phenyl]-2-methylpropanenitrile | 120511-84-4 | C15H17BrN2 |
|
| 5-溴去氰基氢溴酸西酞普兰 | 1-(4'-Fluorophenyl)-1-(3-dimethylaminopropyl)-5-bromophthalane hydrobromide | 479065-02-6 | C19H22Br2FNO |
|
| 5-氯甲基-2-三氟甲基-1,3,4-噁二唑 | 2-trifluoromethyl-1,3,4-oxadiazol-5-ylmethyl chloride | 723286-98-4 | C4H2ClF3N2O |
|
| 5-氯氢氯噻嗪 | 5,6-Dichlor-7-sulfamoyl-3,4-dihydro-1,2,4-benzothiadiazin-1,1-dioxid | 5233-42-1 | C7H7Cl2N3O4S2 |
|
| 5-氯噻吩-2-甲酸甲酯 | methyl 5-chloro-2-thiophenecarboxylate | 35475-03-7 | C6H5ClO2S |
|
| 5-氯去氰基西酞普兰草酸盐 | 5-Chlorodescyano Citalopram Oxalate | 64169-46-6 | C21H23ClFNO5 |
|
| 5-氯乙酰舒泛 | 5-Chloro-6-methyl-1,2,3-oxathiazin-4(3H)-one 2,2-dioxide | 72827-08-8 | C4H4ClNO4S |
|
| 5-氯-N1-甲基苯-1,2-二胺 | 5-chloro-N<sup>1</sup>-methylbenzene-1,2-diamine | 84859-27-8 | C7H9ClN2 |
|
| 5-氯-N-(4-硝基苯基)戊酰胺 | 5-chloro-N-(4-nitrophenyl)pentanamide | 1039914-85-6 | C11H13ClN2O3 |
|
| 5-氯-N-((2R)-2-羟基-3-{[4-(3-氧代-4-吗啉基)-苯基]氨基}丙基)-2-噻吩甲酰胺 | 5-chloro-N-[(2R)-2-hydroxy-3-{[4-(3-oxomorpholin-4-yl)phenyl]amino}propyl]thiophene-2-carboxamide | 721401-53-2 | C18H20ClN3O4S |
|
| 5-氯-3-噻吩甲酸 | 5-chlorothiophene-3-carboxylic acid | 36157-42-3 | C5H3ClO2S |
|
| 5-氯-3-[(1,5-二羟基-2-萘)偶氮]-2-羟基苯磺酸钠 | (benzothiazol-2-yl)-2-(2-aminothiazol-4-yl)-Z-2-methoxyimino-thioacetate | 84994-24-1 | C13H10N4O2S3 |
|
| 5-氯-3-(4-甲基磺酰基)苯基-2-(2-甲基-5-吡啶基)吡啶 | 5-chloro-3-(4-methylthiophenyl)-6'-methyl-[2,3']bipyridine | 292067-97-1 | C18H15ClN2S |
|
| 5-氯-2-羧基-3-噻吩磺酸 | 5-Chloro-3-sulfothiophene-2-carboxylic acid | 187746-94-7 | C5H3ClO5S2 |
|
| 5-氯-2,3-二苯基吡嗪 | 2-chloro-5,6-diphenylpyrazine | 41270-66-0 | C16H11ClN2 |
|
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