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 |
|---|---|---|---|---|
| 3-去[4-(2-哌啶基)乙氧基]苯甲酰基-7-[4-(2-哌啶基)乙氧基]苯甲酰基雷洛昔芬 | 3-Des(4-(2-piperidinyl)ethoxy)benzoyl-7-(4-(2-piperidinyl)ethoxy)benzoyl raloxifene | 1391054-73-1 | C28H27NO4S |
|
| 3-亚甲基异苯并呋喃-1(3H)-酮 | 3-methylidenephthalide | 3453-63-2 | C9H6O2 |
|
| 3-乙酰苯甲酮 | 1-(3-benzoylphenyl)ethan-1-one | 66067-44-5 | C15H12O2 |
|
| 3-乙酰氨基邻苯二甲酸 | 3-acetamidophthalic acid | 15371-06-9 | C10H9NO5 |
|
| 3-乙酰氨基邻苯二甲酰亚胺 | 3-acetamidophthalimide | 6118-65-6 | C10H8N2O3 |
|
| 3-乙酰氨基-5-氨基-2,4,6-三碘苯甲酸 | 3-Acetamido-5-amino-2,4,6-triiodbenzoesaeure | 1713-07-1 | C9H7I3N2O3 |
|
| 3-乙酰基溴库溴铵 | 1-[(2β,3α,5α,16β,17β)-3,17-bis(acetyloxy)-2-(4-morpholinyl)-androstan-16-yl]-1-(2-propenyl)pyrrolidinium bromide | 122483-73-2 | Br*C34H55N2O5 |
|
| 3-乙氧基-异香草酸 | 3-ethoxy-4-methoxybenzoic acid | 2651-55-0 | C10H12O4 |
|
| 3-乙基5-甲基2-(2-氨基乙氧基)甲基-4-(2-氯苯基)-6-甲基吡啶-3,5-二羧酸 | dehydro amlodipine | 113994-41-5 | C20H23ClN2O5 |
|
| 3-丙基-3H-2-苯并呋喃-1-酮 | 3-propyl-3H-isobenzofuran-1-one | 72424-08-9 | C11H12O2 |
|
| 3-丁基-3-羟基-2-苯并呋喃-1-酮 | 3-hydroxy-3-n-butylphthalide | 162050-42-2 | C12H14O3 |
|
| 3-[[[2-[(氨基亚胺甲基)氨基]-4-噻唑基]甲基]硫基]丙酰胺 | 3-<2-(diaminomethyleneamino)-4-thiazolylmethylthio>-propionamide | 76824-16-3 | C8H13N5OS2 |
|
| 3-[[2-[(1H-苯并咪唑-2-亚磺酰基)甲基]-3-甲基-4-吡啶]氧基]-1-丙醇 | demethylrabeprazole | 117976-94-0 | C17H19N3O3S |
|
| 3-[4-[4-(氯磺酰基)苯基]-5-甲基-3-异恶唑基]苯磺酰氯 | 3-(4-(4-(Chlorosulfonyl)phenyl)-5-methylisoxazol-3-yl)benzenesulfonyl chloride | 1373038-63-1 | C16H11Cl2NO5S2 |
|
| 3-[4-(咪唑-1-基甲基)苯基]丙-2-烯酸 | cis-ozagrel | 143945-86-2 | C13H12N2O2 |
|
| 3-[4-(4-氯苯甲酰基)苯氧基]-2-丁酮 | 3-[4-(4-Chlorobenzoyl)phenoxy]butan-2-one | 217636-47-0 | C17H15ClO3 |
|
| 3-[4-(2-甲氧基乙基)苯氧基]-1,2-丙二醇 | 3-<4-(2-methoxyethyl)phenoxy>-1,2-propanediol | 62572-90-1 | C12H18O4 |
|
| 3-[3-(叔丁基氨基)-2-羟基丙氧基]-4-吗啉基-1,2,5-噻二唑单马来酸盐 | timolol maleate | 57073-55-9 | C4H4O4*C13H24N4O3S |
|
| 3-[3-(三氟甲基)苯基]-1-丙胺 | 3-(3-(trifluoromethyl)phenyl)propan-1-amine | 104774-87-0 | C10H12F3N |
|
| 3-[2-(二甲基氨基)乙基]-5-[(1-吡咯烷基磺酰基)甲基]-1H-吲哚-1-甲醇 | [3-[2-(Dimethylamino)ethyl]-5-(pyrrolidin-1-ylsulfonylmethyl)indol-1-yl]methanol | 1018676-02-2 | C18H27N3O3S |
|
| 3-[2((R)-[(S)-(4-苄氧苯基)-（4-氟苯氨基）-甲基]-5-（4-氟苯基）-5-（S）-羟戊酰基]-4（S）-苯基-2-恶唑烷酮 | (4S)-3-[(2R,5S)-2-[(S)-(4-fluoroanilino)-(4-phenylmethoxyphenyl)methyl]-5-(4-fluorophenyl)-5-hydroxypentanoyl]-4-phenyl-1,3-oxazolidin-2-one | 1185883-39-9 | C40H36F2N2O5 |
|
| 3-[(乙酰氧基)甲基]-7-[(溴乙酰)氨基]-8-氧代-(6R-TRANS)-5-硫杂-1-氮杂双环[4,2,0]辛-2-烯-2-羧酸 | N-bromoacetyl-7-aminocephalosporanic acid | 26973-80-8 | C12H13BrN2O6S |
|
| 3-[({2-[(二氨基亚甲基)氨基]-1,3-噻唑-4-基}甲基)硫基]-N-氨基磺酰基丙酰胺 | 3-[[2-(diaminomethylideneamino)-1,3-thiazol-4-yl]methylsulfanyl]-N-sulfamoylpropanamide | 106433-44-7 | C8H14N6O3S3 |
|
| 3-[(2-羟基乙基)氨基]丙腈 | 3-(2-Hydroxyethylamino)propionitrile | 33759-44-3 | C5H10N2O |
|
| 3-[(2,2-二甲氧基乙基)硫基]-1-丙烯 | 2-Allylmercaptoacetaldehyde Dimethylacetal | 84522-35-0 | C7H14O2S |
|
| 3-[(1R)-3-[二(1-甲基乙基)氨基]-1-苯基丙基]-4-羟基-苯甲醛 | (R)-N,N-diisopropyl-3-(5-formyl-2-hydroxyphenyl)-3-phenylpropanamine | 214601-12-4 | C22H29NO2 |
|
| 3-2-(氯甲基)-3-甲基吡啶-4-基)氧基)丙-1-醇 | 2-chloromethyl-4-(3-hydroxypropoxy)-3-methylpyridine | 117976-92-8 | C10H14ClNO2 |
|
| 3-(环丙基甲氧基)-n-(3,5-二氯吡啶-4-基)-4-羟基苯甲酰胺 | 3-(cyclopropylmethoxy)-N-(3,5-dichloropyridin-4-yl)-4-hydroxybenzamide | 475271-62-6 | C16H14Cl2N2O3 |
|
| 3-(二甲基氨基)-1-(2-噻吩基)-1-丙醇 | 3-(N,N-dimethylamino)-1-(thien-2-yl)propan-1-ol | 13636-02-7 | C9H15NOS |
|
| 3-(乙酰氧基甲基)-8-氧代-7-[[2-(四唑-1-基)乙酰基]氨基]-5-硫杂-1-氮杂双环[4.2.0]辛-2-烯-2-羧酸 | 7-((tetrazol-1'-yl)acetylamino)-3-acetyloxymethyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid | 32510-61-5 | C13H14N6O6S |
|
| 3-(乙氧基羰基)-7-氧代-9-氮杂双环[3.3.1]壬烷-9-乙酸乙酯 | 7-ethoxycarbonyl-9-(ethoxycarbonylmethyl)-9-azabicyclo-[3.3.1]nonan-3-one | 115956-03-1 | C15H23NO5 |
|
| 3-(N-苄基-N-甲基氨基)苯丙酮盐酸盐 | 3-(benzyl methylamino)-1-phenylpropan-1-one hydrochloride | 5409-62-1 | C17H19NO*ClH |
|
| 3-(5-甲基-3-苯基-1,2-恶唑-4-基)苯磺酰胺 | [3-(5-methyl-3-phenyl-4-isoxazolyl)phenyl]sulfonamide | 386273-25-2 | C16H14N2O3S |
|
| 3-(5-溴-1-(4-氟苯基)-1,3-二氢异苯并呋喃-1-基)-N,N-二甲基丙烷-1-胺 | {3-[5-bromo-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-1-yl]-propyl}-dimethylamine | 64169-39-7 | C19H21BrFNO |
|
| 3-(5-氯-吡啶-2-基氨基甲酰基)-吡嗪-2-羧酸 | 3-((5-chloropyridin-2-yl)carbamoyl)pyrazine-2-carboxylic acid | 43200-83-5 | C11H7ClN4O3 |
|
| 3-(4H-1,2,4-三唑-4-基)-1H-吡唑-4-甲酰胺 | 5-(4H-1,2,4-triazol-4-yl)-1H-pyrazole-4-carboxamide | 1346604-13-4 | C6H6N6O |
|
| 3-(4-羟基-1-氧代异吲哚-2-基)哌啶-2,6-二酮 | 3-(4-hydroxy-1-oxoisoindolin-2-yl)piperidine-2,6-dione | 1061604-41-8 | C13H12N2O4 |
|
| 3-(4-甲酰基苯基)丙-2-烯酸 | (E)-p-formylcinnamic acid | 66885-68-5 | C10H8O3 |
|
| 3-(4-甲基咪唑-1-基)-5-三氟甲基苯甲酸 | 3-(4-methyl-imidazol-1-yl)-5-trifluoromethylbenzoic acid | 641571-13-3 | C12H9F3N2O2 |
|
| 3-(4-甲基-1H-咪唑-1-基)-5-(三氟甲基)苯甲腈 | 3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)benzonitrile | 641571-12-2 | C12H8F3N3 |
|
| 3-(4-氟苯胺基)-3-氧代丙酸乙酯 | ethyl 3-((4-fluorophenyl)amino)-3-oxopropionate | 104330-60-1 | C11H12FNO3 |
|
| 3-(4-氟苯基)-1-异丙基-1H-吲哚-2-苯甲醛 | 3-(4-fluorophenyl)-1-(1-methylethyl)-1H-indole-2-carboxaldehyde | 101125-34-2 | C18H16FNO |
|
| 3-(4-异丁基苯基)-丙酸 | 3-(4'-isobutylphenyl)propionic acid | 65322-85-2 | C13H18O2 |
|
| 3-(4-三氟甲基 苯基)-1-丙醇 | 3-(4-(trifluoromethyl)phenyl)propan-1-ol | 180635-74-9 | C10H11F3O |
|
| 3-(4-(7H-吡咯[2,3-d]嘧啶-4-基)-1H-吡唑-1-基)-3-(氰甲基)氮杂丁烷 | 3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]azetidin-3-ylacetonitrile | 1187594-16-6 | C14H13N7 |
|
| 3-(3-氯丙基)-7,8-二甲氧基-2,3,4,5-四氢-1H-3-苯并氮杂卓-2-酮 | 7,8-dimethoxy-3-(3-chloropropyl)-1,3,4,5-tetrahydro-2H-3-benzazepin-2-one | 85175-65-1 | C15H20ClNO3 |
|
| 3-(3-(甲基氨基)丙基)-1,3,4,5-四氢-7,8-二甲氧基-2H-3-苯并氮杂卓-2-酮盐酸盐 | 7,8-dimethoxy-3-<3-(methylamino)propyl>-1,3,4,5-tetrahydro-2H-3-benzazepin-2-one hydrochloride | 85175-52-6 | C16H24N2O3*ClH |
|
| 3-(2-甲酰基苯基)-2-(E)-丙烯酸叔丁酯 | (E)-t-butyl 3-(2-formylphenyl)acrylate | 103890-69-3 | C14H16O3 |
|
| 3-(2-甲氧基苯氧基)-1-哌嗪-2-丙醇 | CVT-2513 | 162712-35-8 | C14H22N2O3 |
|
| 3-(2-甲基-5-硝基咪唑-1-基)-1,2-丙二醇 | 3-(2-Methyl-5-nitro-1h-imidazol-1-yl)propane-1,2-diol | 62580-80-7 | C7H11N3O4 |
|
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