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 |
|---|---|---|---|---|
| 美阿沙坦钾杂质B | (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-oxo-3-((2′-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl)-methyl)-2,3-dihydro-1H-benzo[d]imidazole-4-carboxylate | 1417576-00-1 | C28H20N4O8 |
|
| 美阿沙坦钾杂质26 | (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-1-{[2'-(N'-hydroxycarbamimidoyl)biphenyl-4-yl]-methyl}-1H-benzimidazole-7-carboxylate | 1449029-77-9 | C29H26N4O7 |
|
| 美迪紫檀素葡萄糖苷 | medicarpin 3-O-glucoside | 52766-70-8 | C22H24O9 |
|
| 美溴非林 | [99Tc]-Mebrofenin | 78266-06-5 | C15H19BrN2O5 |
|
| 美洛昔康杂质 | 2-Methylsulfamoyl-benzoesaeure | 125372-22-7 | C8H9NO4S |
|
| 美法仑甲酯 | melphalan methyl ester | 88457-23-2 | C14H20Cl2N2O2 |
|
| 美沙拉嗪杂质06 | 2-Hydroxy-3-phenyldiazenylbenzoic acid | 136819-59-5 | C13H10N2O3 |
|
| 美沙拉嗪杂质05 | 2-phenylazo-phenol | 2362-57-4 | C12H10N2O |
|
| 美沙拉嗪杂质03 | m-Hydroxyazobenzol | 2437-11-8 | C12H10N2O |
|
| 美普他酚杂质 | meptazinol p-aminobenzoylcarbamate | 1314003-47-8 | C23H28N2O4 |
|
| 美托洛尔酸乙酯 | ethyl 4-(2-hydroxy-3-isopropyl-amino)-propoxy phenylacetate | 29112-40-1 | C16H25NO4 |
|
| 美托洛尔杂质18(单体) | (-)-Metoprolol hydrochloride | 114218-35-8 | C15H25NO3*ClH |
|
| 罗氟司特-imK | roflumilast N-oxide | 292135-78-5 | C17H14Cl2F2N2O4 |
|
| 罗格列酮相关物质A | (Z)-5-[4-[2-[N-methyl-N-(pyridin-2-yl)amino]ethoxy]benzylidene]thiazolidine-2,4-dione | 160596-25-8 | C18H17N3O3S |
|
| 罗库溴铵杂质3 | androst-2-ene-17-one | 14639-79-3 | C19H28O |
|
| 罗库溴铵杂质3 | Androst-2-en-17-on | 963-75-7 | C19H28O |
|
| 罗哌卡因标准品004 | N-(2,4-dimethylphenyl)picolinamide | 352637-51-5 | C14H14N2O |
|
| 罗哌卡因标准品0-R | (+)-Ropivacaine | 98717-16-9 | C17H26N2O |
|
| 罗哌卡因杂质 | 1-ethyl-piperidine-2-carboxylic acid-(2,6-dimethyl-anilide) | 2180-94-1 | C16H24N2O |
|
| 缬沙坦杂质12 | methyl pentanoyl-L-valinate | 1189547-11-2 | C11H21NO3 |
|
| 缬沙坦-d9（主要） | Valsartan D9 | 1089736-73-1 | C24H29N5O3 |
|
| 维达洛芬 | 2-(4-cyclohexyl-1-naphthyl)propionic acid | 71109-09-6 | C19H22O2 |
|
| 维生素K1杂质1 | vitamin K<sub>1</sub> chromenol | 19274-66-9 | C31H46O2 |
|
| 维生素B1杂质7 | O-Acetyl-thiamin | 3419-28-1 | C14H19N4O2S*Cl |
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| 维生素B1杂质3 | beclotiamine | 13471-78-8 | C12H16ClN4S*Cl |
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| 维格列汀杂质A | (S)-1-glycylpyrrolidine-2-carbonitrile | 914070-99-8 | C7H11N3O |
|
| 维格列汀杂质57 | (S)-1-(2-aminoacetyl)pyrrolidine-2-carbonitrile hydrochloride | 913980-23-1 | C7H11N3O*ClH |
|
| 维格列汀杂质 | (5aS,10aS)-octahydrodipyrrolo[1,2-a:1',2'-d]pyrazine-5,10-dione | 19943-27-2 | C10H14N2O2 |
|
| 维格列汀-12 | (3-hydroxyadamantan-1-ylamino)acetic acid | 1032564-18-3 | C12H19NO3 |
|
| 维格列汀-06 | 1-chloroacetyl-2-cyano-(R)-pyrrolidine | 565452-98-4 | C7H9ClN2O |
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| 红霉素杂质E(EP) | EM 201 | 857839-61-3 | C37H65NO12 |
|
| 红霉素C | erythromycin C | 1675-02-1 | C36H65NO13 |
|
| 红霉素B | erythromycin B | 527-75-3 | C37H67NO12 |
|
| 红霉素A氧化物 | erythromycin A N-oxide | 992-65-4 | C37H67NO14 |
|
| 红霉糖胺 | erythralosamine | 546-57-6 | C29H49NO8 |
|
| 红镰霉素-6-O-β-龙胆二糖苷 | rubrofusarin 6‐O‐β‐gentiobioside | 24577-90-0 | C27H32O15 |
|
| 紫杉醇侧链杂质 | methyl (2R,3R)-phenylisoserine | 157722-44-6 | C10H13NO3 |
|
| 紫杉醇EP杂质O | N-debenzoyl-N-cinnamoylpaclitaxel | 219783-77-4 | C49H53NO14 |
|
| 紫杉醇 C | taxol C | 153415-45-3 | C46H57NO14 |
|
| 索非布韦杂质53 | (S)-2-{[(2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydro-2H-pyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-ylmethoxy](phenoxy)phosphorylamino}propionic acid methyl ester | 1015255-46-5 | C20H25FN3O9P |
|
| 索非布韦杂质14 | 2'-deoxy-2'-chloro-2'-C-methyl-3',5'-di-O-benzoyl-N<sup>4</sup>-benzoylcytidine | 1496551-70-2 | C31H26ClN3O7 |
|
| 索非布韦杂质12 | 1-((2R,3R,4R,5R)-3-chloro-4-hydroxy-5-(hydroxymethyl)-3-methyltetrahydrofuran-2-yl)pyrimidine-2,4(1H,3H)-dione | 1496551-72-4 | C10H13ClN2O5 |
|
| 索非布韦代谢物GS-566500 | (2S)-2-((((2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)(hydroxy)phosphorylamino)propanoic acid | 1233335-78-8 | C13H19FN3O9P |
|
| 索非布韦中间体 | N-[(S)-(2,3,4,5,6-pentafluorophenoxy)phenoxyphosphoryl]-L-alanine isopropyl ester | 1256490-52-4 | C18H17F5NO5P |
|
| 索氟布韦 中间体 SF-C2 | 3',5'-di-O-benzoyl-2'-deoxy-2'-fluoro-2'-C-methyluridine | 863329-65-1 | C24H21FN2O7 |
|
| 索拉非尼杂质 | 4-{4-[({[4-chloro-3-(trifluoromethyl)phenyl]amino}carbonyl)amino]phenoxy}-2-pyridine carboxamide | 284461-74-1 | C20H14ClF3N4O3 |
|
| 索拉非尼 N-氧化物 | BAY 67-3472 | 583840-03-3 | C21H16ClF3N4O4 |
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| 索利那新杂质18 | (1S)-3,4-dihydro-1-phenyl-2(1H)-isoquinolinecarboxylic acid-1-azabicyclo[2.2.2]oct-3-yl ester | 1225338-27-1 | C23H26N2O2 |
|
| 索利那新杂质17 | 2-(1H-imidazole-2-ylcarbonyl)-(1S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline | 1029430-94-1 | C19H17N3O |
|
| 索利那新-索非那新杂质 | (1S)-3,4-dihydro-1-phenyl-2(1H)-isoquinolinecarboxylic acid (3S)-1-azabicyclo[2.2.2]oct-3-yl ester | 732228-02-3 | C23H26N2O2 |
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