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 |
|---|---|---|---|---|
| 奥扎格雷标准品015 | (E)-3-(4-(hydroxymethyl)phenyl)acrylic acid | 1332370-00-9 | C10H10O3 |
|
| 奥布卡因盐酸盐 | oxybuprocaine hydrochloride | 5987-82-6 | C17H28N2O3*ClH |
|
| 奥塞米韦酸甲酯 | GS 4071 | 208720-71-2 | C15H26N2O4 |
|
| 奥司他韦酒石酸盐 | oseltamivir acid | 187227-45-8 | C14H24N2O4 |
|
| 奥司他韦杂质97 | (3R,4S,5R)-ethyl 3,4-epoxy-5-hydroxycyclohex-1-ene-1-carboxylate | 1476028-68-8 | C9H12O4 |
|
| 奥司他韦杂质8 | ethyl (3R,4R,5S)-4,5-diamino-3-(pent-3-yloxy)cyclohex-1-ene-1-carboxylate | 212504-89-7 | C14H26N2O3 |
|
| 奥司他韦杂质63 | ethyl (3R,4S,5R)-5-N-(1,1-dimethylethyl)amino-3-(1-ethylpropoxy)-4-hydroxy-1-cyclohexene-1-carboxylate | 651324-04-8 | C18H33NO4 |
|
| 奥司他韦杂质58 | ethyl (3aR,7R,7aR)-2,2-dimethyl-7-methanesulfonyloxy-3a,6,7,7a-tetrahydrobenzo[1,3]dioxole-5-carboxylate | 204254-90-0 | C15H24O7S |
|
| 奥司他韦杂质55 | ethyl (3aR,7R,7aR)-2,2-dimethyl-7-methanesulfonyloxy-3a,6,7,7a-tetrahydrobenzo[1,3]dioxole-5-carboxylate | 204254-84-2 | C13H20O7S |
|
| 奥司他韦杂质35 | (1S,5R,6R)-5-(1-ethyl-propoxy)-7-oxa-bicyclo[4.1.0]hept-3-ene-3-carboxylic acid ethyl ester | 757965-01-8 | C14H22O4 |
|
| 奥司他韦杂质23 | (3R,4R,5S)-4-acetylamino-5-acetylamino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid ethyl ester | 1191921-01-3 | C18H30N2O5 |
|
| 奥司他韦杂质21 | ethyl (3R,4R,5S)-5-N,N-diallylamino-4-(1,1-dimethylethyl)amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate | 651324-06-0 | C24H42N2O3 |
|
| 奥司他韦杂质2 | ethyl (3R,4S,5R)-5-hydroxy-3,4-isopropylidenedioxycyclohex-1-enecarboxylate | 136994-78-0 | C12H18O5 |
|
| 奥司他韦杂质17 | ethyl (1S,5S,6S)-5-(pentan-3-yloxy)-7-oxabicyclo[4.1.0]hept-3-ene-3-carboxylate | 2413185-88-1 | C14H22O4 |
|
| 奥司他韦杂质104 | ethyl (3R,4R,5S)-4-acetamido-5-nitro-3-(pentan-3-yloxy)cyclohex-1-ene-1-carboxylate | 949164-64-1 | C16H26N2O6 |
|
| 奥司他韦杂质 | ethyl (3R,4R,5S)-4-N-acetyl(1,1-dimethylethyl)amino-5-N,N-diallylamino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate | 651324-07-1 | C26H44N2O4 |
|
| 奥利斯特相关物质D | N-Formyl-L-leucine (3S,4R,6S)-3-Hexyl-3,4,5,6-tetrahydro-2-oxo-6-undecyl-2H-pyran-4-yl Ester | 130793-27-0 | C29H53NO5 |
|
| 奎硫平去羟乙基杂质 | O-Dealkyl Quetiapine | 329216-67-3 | C19H21N3OS |
|
| 奈马克丁 | nemadectin | 102130-84-7 | C36H52O8 |
|
| 头孢羟氨苄有关杂质F | 4-hydroxyphenylglycylcefadroxil | 147103-95-5 | C24H24N4O7S |
|
| 头孢美唑钠-头孢美唑杂质 | Benzhydryl 7α-cyanomethylthioacetamido-7α-methoxy-3-(1-methyl-1H-tetrazol-5-yl)thiomethyl-3-cephem-4-carboxylate | 56796-19-1 | C28H27N7O5S3 |
|
| 头孢硫脒杂质6 | 7-chloroacetamidocephalosporanic acid | 28240-16-6 | C12H13ClN2O6S |
|
| 头孢硫脒杂质5 | 7-cloroacetamido-3-deacetoxy-ceph-3-em-4-carboxylic acid | 40818-86-8 | C10H11ClN2O4S |
|
| 头孢氨苄亚砜 | cefalexin-(R)-sulfoxide | 56193-21-6 | C16H17N3O5S |
|
| 头孢替唑杂质3,头孢替唑中间体 | 7-amino-3-[2-(1,3,4)-thiadiazolyl]thiomethyl-3-cephem-4-carboxylic acid | 24209-43-6 | C10H10N4O3S3 |
|
| 头孢曲松钠杂质1 | 7β-Aminocephalosporanic acid | 1214622-93-1 | C10H12N2O5S |
|
| 头孢塔齐定杂质A | (6R,7R)-7-[2-(2-amino-4-thiazolyl)-2-(Z)-(2,2-dimethylacetoxyimino)acetamido]-3-[(pyridinium)methyl]-2-cephem-4-carboxylate | 1000980-60-8 | C22H22N6O7S2 |
|
| 头孢地尼杂质S | (6R,7R)-7-[[(2Z)-2-acetyloxyimino-2-(2-amino-1,3-thiazol-4-yl)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid | 127770-93-8 | C16H15N5O6S2 |
|
| 头孢地尼噻嗪模拟 | (2R,5Z)-2-[(R)-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-hydroxyiminoacetyl]amino]-carboxymethyl]-5-ethylidene-2H-1,3-thiazine-4-carboxylic acid | 178422-39-4 | C14H15N5O6S2 |
|
| 头孢地尼亚砜 | Cefdinir sulfoxide | 934986-48-8 | C14H13N5O6S2 |
|
| 头孢地尼3-甲基杂质(USP) | 3-methyl cefdinir | 71091-93-5 | C13H13N5O5S2 |
|
| 头孢唑林钠杂质3 | (2R)-2-amino-6-[[(4R,5R)-3,11-dioxo-10-oxa-6-thia-2-azatricyclo[6.3.0.02,5]undec-1(8)-en-4-yl]amino]-6-oxohexanoic acid | 2429-86-9 | C14H17N3O6S |
|
| 头孢唑啉杂质C | 7-<1-(1H)-tetrazolylacetamido>-3-methyl-Δ<sup>3</sup>-cephem-4-carboxylic acid | 56842-77-4 | C11H12N6O4S |
|
| 头孢唑啉EP杂质B | Cefazolin pivaloyl | 2384108-14-7 | C16H20N4O4S3 |
|
| 头孢哌酮二水合物 | Cefoperazone dihydrate | 113826-44-1 | C25H31N9O10S2 |
|
| 头孢哌酮 | cefoperazone | 62893-19-0 | C25H27N9O8S2 |
|
| 头孢呋辛酯 | N-(2,2,2-Trichloroacetyl)cefuroxime | 76598-06-6 | C18H15Cl3N4O9S |
|
| 头孢卡品 | cefcapene | 135889-00-8 | C17H19N5O6S2 |
|
| 头孢他啶叔丁酯 | (Z)-7-(2-(2-aminothiazol-4-yl)-2-(((1-(tertbutoxy)-2-methyl-1-oxopropan-2-yl)oxy)amino)acetamido)-8-oxo-3-(pyridin-1-ium-1-ylmethyl)-5-thia-1-azabicyclo[4.2.0]oct-2-en-2-carboxylate | 102772-66-7 | C26H30N6O7S2 |
|
| 头孢他啶EP杂质H | (6R,7R)-7-[[(Z)-2-(2-aminothiazol-4-yl)-2-[(1-methoxycarbonyl-1-methylethoxy) imino]acetyl]amino]-8-oxo-3-[(1-pyridinio)methyl]-5-thia-1-azabicyclo[4.2.0] oct-2-ene-2-carboxylate | 1354396-23-8 | C23H24N6O7S2 |
|
| 头孢丙烯(E)-异构体 | E-cefprozil | 92676-86-3 | C18H19N3O5S |
|
| 大黄酚-1-O-Β-三葡萄糖苷 | Chrysophanol 1-triglucoside | 120181-07-9 | C33H40O19 |
|
| 大黄素甲醚-1-O-beta-D-葡萄糖苷 | physcion-8-O-β-D-glucoside | 26296-54-8 | C22H22O10 |
|
| 大比泻兰乙二醇酯杂质64 | 2-[(4-carbamoylphenyl)amino]acetic Acid | 355809-32-4 | C9H10N2O3 |
|
| 多西拉敏杂质5 | Doxylamine N'-Oxide | 99430-77-0 | C17H22N2O2 |
|
| 多西拉敏杂质 | 2-(1-hydroxy-1-methylbenzyl)pyridine 1-oxide | 100393-43-9 | C13H13NO2 |
|
| 多西拉敏4-吡啶基异构体 | 4-[1-(2-dimethylamino-ethoxy)-1-phenyl-ethyl]-pyridine | 873407-01-3 | C17H22N2O |
|
| 多虑平杂质C | desmethyldoxepin hydrochloride salt | 4504-96-5 | C18H19NO*ClH |
|
| 多索茶碱杂质29 | ethyl 2-(1,3-dimethyl-2,6-dioxo-2,3-dihydro-1H-purin-7(6H)-yl)acetate | 7029-96-1 | C11H14N4O4 |
|
| 多索茶碱杂质11 | 7,7'-methylenebis<theophylline> | 109403-76-1 | C15H16N8O4 |
|
联系我们
关注我们
公众号
