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 |
|---|---|---|---|---|
| 紫杉醇 C | taxol C | 153415-45-3 | C46H57NO14 |
|
| 索非那新EP杂质H | (1S)-3,4-dihydro-1-phenyl-2-(1H)-isoquinolinecarboxylic acid (3S)-1-azabicyclo[2.2.2]oct-3-yl ester succinate | 862207-71-4 | C4H6O4*C23H26N2O2 |
|
| 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34 | GS-606965 | 1015073-43-4 | C10H14FN2O8P |
|
| 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 |
|
| 索拉非尼相关物质8 | 4-(4-(3-(2-chloro-3-(trifluoroMethyl)phenyl)ureido)phenoxy)-N-MethylpicolinaMide | 1431697-81-2 | C21H16ClF3N4O3 |
|
| 索拉非尼相关化合物11 | Unii-Q3WJ23B6JD | 2004659-83-8 | C20H19N5O3 |
|
| 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 |
|
| 索利那新杂质29 | 4R-Hydroxysolifenacin | 861998-77-8 | C23H26N2O3 |
|
| 索利那新杂质20 | N-acetyl-(1R)-phenyl-1,2,3,4-tetrahydroisoquinoline | 1300713-32-9 | C17H17NO |
|
| 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 |
|
| 粗毛甘草素F | glyasperin F | 145382-61-2 | C20H18O6 |
|
| 色氨酸EP杂质A | 1,1'-ethylidenebis(L-tryptophan) | 132685-02-0 | C24H26N4O4 |
|
| 米拉贝隆杂质M5 | (R)-N-(4-(2-((2-hydroxy-2-phenylethyl)amino)ethyl)phenyl)acetamide | 1365244-63-8 | C18H22N2O2 |
|
| 米拉贝隆杂质 | 4-(2-((2-Phenylethyl)amino)ethyl)aniline hydrochloride | 1581285-26-8 | C16H21ClN2 |
|
| 米托蒽醌甲磺酸盐 | [10-(4,5-dimethoxy-2-methyl-3,6-dioxo-1,4-cyclohexadien-1-yl)decyl]triphenylphosphonium methanesulfonate | 845959-50-4 | CH3O3S*C37H44O4P |
|
| 米力农杂质A | 1,6-dihydro-2-methyl-6-oxo-<3,4'-bipyridine>-5-carboxamide | 80047-24-1 | C12H11N3O2 |
|
| 立他斯特杂质 | ((S)-benzyl 2-(2-(benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6-carboxamido)-3-(3-methylsulfonyl)phenyl)propanoate | 1194550-67-8 | C36H30Cl2N2O7S |
|
| 稻瘟净 | thiophosphoric acid S-benzyl ester O,O'-diethyl ester | 13286-32-3 | C11H17O3PS |
|
| 科立内脂二醇 | (3aR,4S,5R,6aS)-5-hydroxy-4-(hydroxymethyl)hexahydro-2H-cyclopenta[b]furan-2-one | 32233-40-2 | C8H12O4 |
|
| 福辛普利拉-D7 | Fosinoprilat | 95399-71-6 | C23H34NO5P |
|
| 福莫特罗杂质B | N-(2-Hydroxy-5-((1RS)-1-hydroxy-2-((2-(4-methoxyphenyl)ethyl)amino)ethyl)phenyl)formamide | 1224588-66-2 | C18H22N2O4 |
|
| 福莫特罗杂质24 | N-(2-Hydroxy-5-{(R)-1-hydroxy-2-[(S)-2-(4-hydroxy-phenyl)-1-methyl-ethylamino]-ethyl}-phenyl)-formamide | 49861-92-9 | C18H22N2O4 |
|
| 福莫特罗EP杂质H | N-(5-((1R)-2-(Benzyl((1R)-2-(4-methoxyphenyl)-1-methylethyl)amino)-1-hydroxyethyl)-2-hydroxyphenyl)formamide | 1337876-26-2 | C26H30N2O4 |
|
| 福多司坦杂质 | 3,3'-disulfanediylbis(propan-1-ol) | 30453-21-5 | C6H14O2S2 |
|
| 福多司坦 | fudosteine | 1023971-10-9 | C6H13NO3S |
|
| 磺达肝葵钠杂质 | Unii-3S9zqk69SK | 348625-84-3 | C13H21NO19S3 |
|
| 磺胺甲噁唑杂质F | 4-amino-N-(3-methyl- 1,2-oxazol-5-yl)benzene-1-sulfonamide | 17103-52-5 | C10H11N3O3S |
|
| 磺胺甲噁唑N4-葡胺 | Sulfamethoxazole N4-glucoside | 119691-75-7 | C16H21N3O8S |
|
| 磷霉素氨丁三醇EP杂质D | (2-(((2-(2-Amino-3-hydroxy-2-(hydroxymethyl)propoxy)-1-hydroxypropyl)hydroxyphosphoryl)oxy)-1-hydroxypropyl)phosphonic acid | 1262243-12-8 | C10H25NO11P2 |
|
| 磷霉素氨丁三醇EP杂质B | [2-[2-amino-3-hydroxy-2-(hydroxymethyl)propoxy]-1-hydroxypropyl]phosphonic acid | 1262243-11-7 | C7H18NO7P |
|
| 磷酸利美尼定 | Rilmenidine phosphate | 85409-38-7 | C10H16N2O*H3O4P |
|
| 碘海醇杂质I | N,N'-bis(2,3-dihydroxypropyl)-3,4-dihydro-2-hydroxymethyl-5,7-diiodo-2H-1,4-benzoxazine-6,8-dicarboxamide | 196309-19-0 | C17H23I2N3O8 |
|
| 碘喷托 | N,N'-bis(2,3-dihydroxypropyl)-5-[N-(2-hydroxy-3-methoxypropyl)acetamido]-2,4,6-triiodoisophthalamide | 89797-00-2 | C20H28I3N3O9 |
|
| 硼替佐米杂质4 | (S)-N-(1-(3-Methylbutanamido)-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxamide | 862894-96-0 | C19H22N4O3 |
|
| 硼替佐米杂质32 | "(alphaS)-(1R,2R,3S,5R)-Pinanediol-1-amino-3-methylbutane-1-boronate Trifluoroacetic Acid Salt" | 1310383-72-2 | C17H29BF3NO4 |
|
| 硼替佐米杂质2 | Pyrazine-2-carboxylic acid [(S)-1-((R)-1-hydroxy-3-methyl-butylcarbamoyl)-2-phenyl-ethyl]-amide | 289472-78-2 | C19H24N4O3 |
|
| 硼替佐米杂质 | bortezomib | 390800-88-1 | C57H69B3N12O9 |
|
| 硫酸大观霉素(四水) | sulfuric acid;(1R,3S,5R,8R,10R,11S,12S,13R,14S)-8,12,14-trihydroxy-5-methyl-11,13-bis(methylamino)-2,4,9-trioxatricyclo[8.4.0.03,8]tetradecan-7-one;hydrate | 64058-48-6 | C14H28N2O12S |
|
| 硫酸壮观霉素 | spectinomycin sulfate tetrahydrate | 23312-56-3 | C14H24N2O7*H2O4S |
|
| 硫辛酸杂质D | 2-oxide-β-lipoic acid | 108015-78-7 | C8H14O3S2 |
|
| 硫胺素乙酸酯盐酸盐 | O-Acetyl-thiamin-hydrochlorid | 74144-47-1 | C14H19N4O2S*ClH*Cl |
|
| 硫胺杂质 | 3-(2-ethyl-4-amino-pyrimidin-5-ylmethyl)-5-(2-hydroxy-ethyl)-4-methyl-thiazolium; bromide hydrobromide | 6309-04-2 | BrH*Br*C13H19N4OS |
|
联系我们
关注我们
公众号
