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 |
|---|---|---|---|---|
| 来那度胺杂质12 | 2-(4-nitro-1-oxo-1,3-dihydroisoindol-2-yl)glutaric acid | 295357-72-1 | C13H12N2O7 |
|
| 来氟米特杂质G(EP)标准品 | 5-methyl-isoxazole-4-carboxylic acid <i>p</i>-toluidide | 724429-16-7 | C12H12N2O2 |
|
| 来氟米特杂质F | 5-Methyl-N-(2-(trifluoromethyl)phenyl)isoxazole-4-carboxamide | 1403564-06-6 | C12H9F3N2O2 |
|
| 杜鲁特韦杂质5 | 4-Desfluoro-6-fluoro dolutegravir | 2244161-72-4 | C20H19F2N3O5 |
|
| 杂质帕瑞昔布H | Benzenesulfonamide, N-hydroxy-4-(5-methyl-3-phenyl-4-isoxazolyl)- | 501093-49-8 | C16H14N2O4S |
|
| 替马西泮相关物质F | 7-Chlor-1-methyl-5-phenyl-4,5-dihydro-2H-1,4-benzodiazepin-2,3-(1H)-dion | 3294-96-0 | C16H13ClN2O2 |
|
| 替诺福韦酯杂质37 | ethyl p-toluenesulfonyloxymethylphosphonate | 161760-03-8 | C10H15O6PS |
|
| 替诺福韦酯杂质10 | N-(purine-6-yl)-1-amino-2-propanol | 16958-60-4 | C8H11N5O |
|
| 替诺福韦杂质B | (R)-9-(1-methyl-2-hydroxyethyl)adeninde | 36817-69-3 | C8H11N5O |
|
| 替诺福韦杂质113 | 4-pivaloylamino-7-iodo-3H,5H-pyrrolo[3,2-d]pyrimidine | 1335287-28-9 | C11H13IN4O |
|
| 替诺福韦二聚 | 2,4,6,8-Tetraoxa-5-phosphanonanedioic acid, 5-[[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl]-, 1-methyl 9-(1-methylethyl) ester, 5-oxide | 1246812-43-0 | C17H26N5O10P |
|
| 替诺福韦二乙酯 | (R)-9-[2-(diethylphosphonomethoxy)propyl]adenine | 180587-75-1 | C13H22N5O4P |
|
| 替罗非班杂质丁二盐酸盐 | 1,5-di(4-pyridyl)pentane | 25382-33-6 | C15H18N2 |
|
| 替罗非班杂质 | 4-(4-Chloro-butyl)-piperidine | 464175-13-1 | C9H18ClN |
|
| 替罗非班-丁基-d9，盐酸盐 | Tirofiban-d9 Hydrochloride | 1331911-68-2 | C22H37ClN2O5S |
|
| 替米沙坦氯代物 | 4'-[[5-chloro-1,7'-dimethyl-2'-propyl-1H,3'H-(2,5'-dibenzimidazolyl)-3'-yl]methyl]-(1,1'-biphenyl)-2-carboxylic acid | 885045-90-9 | C33H29ClN4O2 |
|
| 替米沙坦杂质B | 4'-((7-Methyl-5-(1-methyl-1H-benzimidazol-2-yl)-2-propyl-1H-benzimidazol-1-yl)methyl)biphenyl-2-carboxylic acid | 1026353-20-7 | C33H30N4O2 |
|
| 替米沙坦杂质34 | 1-[4-N-butyrylamino-3-methyl-5-aminophenyl]-3N-methylbenzimidazole | 1083158-65-9 | C19H22N4O |
|
| 替米沙坦N-去甲基杂质 | Desmethyl Telmisartan | 144701-81-5 | C32H28N4O2 |
|
| 替米沙坦-d3 | 4-{[2-n-propyl-4-methyl-6-(1-methyl-d<sub>3</sub>-benzoimidazol-2-yl)benzoimidazol-1-yl]methyl}biphenyl-2-carboxylic acid | 1189889-44-8 | C33H30N4O2 |
|
| 替比培南杂质 | S-(azetidin-3-yl) ethanethioate | 886615-18-5 | C5H9NOS |
|
| 替格瑞洛羟基杂质 | (1S,2S,3R,5S)-3-(7-hydroxy-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol | 1445580-43-7 | C14H21N5O5S |
|
| 替格瑞洛杂质B | (1S,2S)-2-(3,4-Difluorophenyl)cyclopropanamine | 1459719-81-3 | C9H9F2N |
|
| 替格瑞洛杂质44 | 4-chloro-6-methoxy-2-(propylthio)pyrimidin-5-amine | 1431867-40-1 | C8H12ClN3OS |
|
| 替格瑞洛杂质27 | ethyl 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-yloxy)acetate | 1402150-01-9 | C19H26ClN5O5S |
|
| 替格瑞洛杂质27 | (1R,2S)-2-(4-fluorophenyl)cyclopropan-1-amine hydrochloride | 1314324-00-9 | C9H10FN*ClH |
|
| 替格瑞洛杂质14 | N-[4,6-dichloro-2-(propylthio)pyrimidin-5-yl]formamide | 1402150-28-0 | C8H9Cl2N3OS |
|
| 替格瑞洛杂质128 | (4R,5R)-2,2-dimethyl-5-vinyl-[1,3]dioxolane-4-carbaldehyde | 155934-55-7 | C8H12O3 |
|
| 替格瑞洛杂质 | ethyl 2-((3aR,4S,6R,6aS)-6-amino-2,2-dimethyl-tetrahydro-3aH-cyclopenta[d][1,3]dioxol-4-yloxy)acetate | 1265919-24-1 | C12H21NO5 |
|
| 替格瑞洛中间体1脱保护杂质 | (1S,2S,3R,5S)-3-(7-chloro-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol | 1354945-69-9 | C14H20ClN5O4S |
|
| 替卡西林钠杂质A | 6β-(2-thiophen-3-yl-acetylamino)-penicillanic acid | 36041-93-7 | C14H16N2O4S2 |
|
| 替卡西林钠 | Ticarcillin sodium | 29457-07-6 | C15H16N2NaO6S2 |
|
| 替卡西林杂质A | (5-ethyl-2-thienyl)phenylmethanone | 6933-26-2 | C13H12OS |
|
| 替卡格雷相关化合物3 | 1-amino-2,3-O-isopropylidene dioxycyclopentane-4-ol | 88756-83-6 | C8H15NO3 |
|
| 替卡格雷标准品001 | 2-n-Propylthiouracil | 54460-95-6 | C7H10N2OS |
|
| 替卡格雷杂质J | (1S,2S,3R,5S)-3-((5-amino-6-chloro-2-(propylthio)pyrimidin-4-yl)-amino)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol | 1402150-32-6 | C14H23ClN4O4S |
|
| 替卡格雷杂质8 | 4,6-dichloro-2-(propylthio)pyrimidine | 1401318-10-2 | C7H8Cl2N2S |
|
| 替卡格雷杂质5 | 2-(3,4-difluorophenyl)cyclopropylamine | 1414348-35-8 | C9H9F2N |
|
| 替加环素代谢物M6 | 9-Aminominocycline | 149934-19-0 | C23H28N4O7 |
|
| 替加环素USP杂质E | Tigecycline, (4R)- | 1422262-97-2 | C29H39N5O8 |
|
| 更昔洛韦杂质11 | (+/-)-N<sup>2</sup>-acetyl-9-<(2,3-diacetoxy-1-propoxy)methyl>guanine | 96429-68-4 | C15H19N5O7 |
|
| 更昔洛韦双缬氨酸酯 | 2-((2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy)-1,3-propanediyl bis(L-valinate) | 130914-71-5 | C19H31N7O6 |
|
| 更昔洛韦双乙酸酯 | ganciclovir diacetate | 86357-19-9 | C13H17N5O6 |
|
| 更昔洛韦单-O-丙酸酯 | ganciclovir monopropionate | 194159-18-7 | C12H17N5O5 |
|
| 曲沃前列素中间体 | [1,1'-biphenyl]-4-carboxylic acid (3aR,4R,5R,6aS)-hexahydro-4-[(1E,3R)-3-hydroxy-4-[3-(trifluoromethyl)phenoxy]-1-buten-1-yl]-2-oxo-2H-cyclopenta[b]furan-5-yl ester | 114488-91-4 | C31H27F3O6 |
|
| 曲恩汀杂质 | N,N,N',N'-tetrakis-(2-aminoethyl)ethylenediamine | 4097-90-9 | C10H28N6 |
|
| 曲司氯胺杂质 C | Azoniaspironortropanol chloride | 3464-71-9 | C11H20ClNO |
|
| 普萘洛尔杂质 | 1-<<(1-methylethyl)-formyl>amino>-3-(1-naphthalenyloxy)-2-propanol | 77252-87-0 | C17H21NO3 |
|
| 普芦卡必利杂质28 | ethyl 4-[[(4-amino-5-chloro-2,3-dihydrobenzofuran-7-yl)carbonyl]amino]-1-piperidinecarboxylate | 137211-63-3 | C17H22ClN3O4 |
|
| 普罗帕酮杂质B(EP/BP/USP) | Desphenethyl-(E)-styrylpropafenone | 88308-22-9 | C21H25NO3 |
|
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