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 |
|---|---|---|---|---|
| 甲泼尼龙杂质24 | 17-Hydroxy-6-methyl-3,20-dioxopregna-1,4,9(11)-trien-21-yl acetate | 93239-37-3 | C24H30O5 |
|
| 甲氨蝶呤二甲基酯 | dimethyl N-(4-(((2,4-diaminopteridin-6-yl)methyl)(methyl)amino)benzoyl)-L-glutamate | 34378-65-9 | C22H26N8O5 |
|
| 甲氨蝶呤alpha-甲酯 | Methotrexate 1-methyl ester | 66147-29-3 | C21H24N8O5 |
|
| 甲氧基苄胺基吡啶 | 2-(4-methoxybenzylamino)pyridine | 52818-63-0 | C13H14N2O |
|
| 4-羟基-2-甲基-2H-1,2-苯并噻嗪-3-羧酸甲酯-1,1-二氧化物 | methyl 2-methyl-4-hydroxy-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide | 35511-15-0 | C11H11NO5S |
|
| 甲基多巴EP杂质B | l-α-Methyl-β-p-methoxyphenylalanin | 65555-88-6 | C11H15NO3 |
|
| 甲基三苯基甲基醚 | methoxytriphenylmethane | 596-31-6 | C20H18O |
|
| 甲基3,5-二羟基-2-萘酯 | methyl 3,5-dihydroxy-2-naphthoate | 185989-39-3 | C12H10O4 |
|
| 甲基2-脱氧-D-赤式-吡喃戊糖苷 | methyl-2-deoxyribopyranoside | 863396-35-4 | C6H12O4 |
|
| 甲基(2-氯苯基)(2-氧代-2,6,7,7alpha-四氢噻吩并[3,2-c]吡啶-5(4H)-基)乙酸酯 | 2-Oxo clopidogrel hydrochloride | 109904-27-0 | C16H17Cl2NO3S |
|
| 甲基(1S,4R)-4-氨基-2-环戊烯-1-羧酸酯 | (cis)-methyl 4-aminocyclopent-2-enecarboxylate | 138923-03-2 | C7H11NO2 |
|
| 甲基(1S,17S)-17-(beta-L-吡喃葡萄糖基氧基)-18,23-二氧杂-3,13-二氮杂六环[13.7.1.01,13.02,10.04,9.016,21]二十三碳-2(10),4,6,8,19-五烯-20-羧酸酯 | Methyl (1S,17S)-17-[(2R,3S,4R,5R,6S)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-18,23-dioxa-3,13-diazahexacyclo[13.7.1.01,13.02,10.04,9.016,21]tricosa-2(10),4,6,8,19-pentaene-20-carboxylate | 54422-49-0 | C27H32N2O10 |
|
| 甲基 1-C-[4-氯-3-[(4-乙氧基苯基)甲基]苯基]-D-吡喃葡萄糖苷 | (3R,4S,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)-2-methoxytetrahydro-2H-pyran-3,4,5-triol | 461432-24-6 | C22H27ClO7 |
|
| 甲基 1-C-[3-(苯并[b]噻吩-2-基甲基)-4-氟苯基]-α-D-吡喃葡萄糖苷 | methyl 1-C-[3-(1-benzothiophen-2-ylmethyl)-4-fluorophenyl]-α-glucopyranoside | 1034305-23-1 | C22H23FO6S |
|
| 生物素杂质27 | vitamin H | 21788-37-4 | C10H16N2O3S |
|
| 甘草皂苷G2 | licoricesaponin G2 | 118441-84-2 | C42H62O17 |
|
| 瑞舒伐他汀钙盐异构体光降解-5 | (3R,5S)-5-((R)-8-Fluoro-4-isopropyl-2-(N-methylmethylsulfonamido)-5,6-dihydrobenzo[h]quinazolin-6-yl)-3,5-dihydroxypentanoic acid | 854898-48-9 | C22H28FN3O6S |
|
| 瑞舒伐他汀钙杂质40 | 2-((4R,6S)-6-(hydroxymethyl)-2,2-dimethyl-1,3-dioxane-4-yl)acetic acid | 154877-92-6 | C9H16O5 |
|
| 瑞舒伐他汀钙中间体RSB-3 | 6-(4'-fluoro)phenyl-2-hydroxy-4-isopropyl-5-methoxycarbonylpyrimidine | 488798-37-4 | C15H15FN2O3 |
|
| 瑞舒伐他汀杂质钠盐(5氧瑞舒伐他汀钠盐) | rosuvastatin impurity C | 1422619-13-3 | C22H26FN3O6S |
|
| 瑞舒伐他汀杂质90 | Qfh4rfg7WF | 2226413-62-1 | C38H44F2N6O8S2 |
|
| 瑞舒伐他汀杂质89 | Rosuvastatin calcium impurity E [EP] | 2226413-61-0 | C38H46F2N6O9S2 |
|
| 瑞舒伐他汀杂质121 | methyl 2-((4R,6S)-6-(hydroxymethyl)-2,2-dimethyl-1,3-dioxane-4-yl)acetate | 140164-51-8 | C10H18O5 |
|
| 瑞舒伐他汀杂质113 | 6-chloromethyl-β-keto-ς-lactone | 135999-58-5 | C6H7ClO3 |
|
| 瑞舒伐他汀杂质 | 2,6-Heptadienoic acid, 7-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-5-hydroxy-, (2Z,5S,6E)- | 1422954-12-8 | C22H26FN3O5S |
|
| 瑞舒伐他汀杂质 | (S)-6-chloro-5-hydroxy-3-oxohexanoic acid, 1,1-dimethylethyl ester | 319924-73-7 | C10H17ClO4 |
|
| 瑞舒伐他汀杂质 | tert-butyl (R)-6-chloro-5-hydroxy-3-oxohexanoate | 404958-08-3 | C10H17ClO4 |
|
| 瑞舒伐他汀取代羟基戊烯酸 | (4E)-5-{4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl}-(3S)-hydroxy-4-pentenoic acid | 910867-11-7 | C20H24FN3O5S |
|
| 瑞格列奈相关物质C | (S)-2-ethoxy-4-[2-({2-phenyl-1-[2-(piperidin-1-yl)phenyl]ethyl}amino)-2-oxoethyl]benzoic acid | 107362-12-9 | C30H34N2O4 |
|
| 瑞戈非尼杂质4 | 4-(4-(3-(4-chloro-3-(trifluoromethyl)phenyl)ureido)-3-fluorophenoxy) picolinic acid | 1187945-05-6 | C20H12ClF4N3O4 |
|
| 瑞德西韦相关化合物5 | (2R,3R,4R,5R)-2-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-3,4-bis(benzyloxy)-5-((benzyloxy)methyl)tetrahydrofuran-2-carbonitrile | 1355357-49-1 | C33H31N5O4 |
|
| 瑞德西韦杂质1 | (3R,4R,5R)-2-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-3,4-bis(benzyloxy)-5-((benzyloxy)methyl)tetrahydrofuran-2-ol | 1355049-94-3 | C32H32N4O5 |
|
| 瑞巴匹特2-氯杂质 | 2-(2-chlorobenzamido)-3-(2-oxo-1,2-dihydroquinolin-4-yl)propanoic acid | 90098-06-9 | C19H15ClN2O4 |
|
| 瑞宁得杂质 | 2-[3-(1-carbamoyl-1-methylethyl)-5-[1,2,4]triazol-1-ylmethylphenyl]-isobutyramide | 120512-04-1 | C17H23N5O2 |
|
| 瑞加德松杂质1 | 1-{9-[(4S,2R,3R,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-6-aminopurin-2-yl}pyrazole-4-carboxylic acid | 313348-29-7 | C14H15N7O6 |
|
| 琥珀酸钠氯霉素 | Chloramphenicol alpha-succinate sodium salt | 982-57-0 | C15H16Cl2N2NaO8 |
|
| 环苯扎林杂质3 | 10-bromo-10,11-dihydro-dibenzo[<i>a,d</i>]cyclohepten-5-one | 24167-44-0 | C15H11BrO |
|
| 环索奈德 | ciclesonide | 126544-47-6 | C32H44O7 |
|
| 环己基雷米普利类似物 | Hexahydroramipril | 99742-35-5 | C23H38N2O5 |
|
| 环吡酮杂质B | 6-Cyclohexyl-4-methyl-2-pyron | 14818-35-0 | C12H16O2 |
|
| 环丙沙星相关物质 | 6-[(2-aminoethyl)amino]-7-chloro-1-cyclopropyl-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid hydrochloride | 528851-30-1 | C15H16ClN3O3*ClH |
|
| 环丙沙星杂质7 | 4-Methoxy-3-indolylmethyl glucosinolate | 83327-21-3 | C17H22N2O10S2 |
|
| 环丙沙星杂质7 | 7-[4-(ethoxycarbonyl)piperazin-1-yl]-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxoquinoline-3-carboxylic acid | 93594-29-7 | C20H22FN3O5 |
|
| 环丙基3-氟苄基甲酮 | 2-(3-fluorophenyl)-1-cyclopropylethan-1-one | 952722-64-4 | C11H11FO |
|
| 特比萘芬二聚体杂质 | Terbinafine dimer | 934365-23-8 | C36H40N2 |
|
| 特拉沃普罗斯特杂质 | (+/-)-Atovaquone Impurity C | 1809464-27-4 | C22H17ClO3 |
|
| 特拉唑嗪杂质D(EP) | Destetrahydrofuranyl terazosin | 102714-74-9 | C15H19N5O3 |
|
| 特拉唑嗪杂质 | 1-(4-Amino-6,7-dimethoxy-2-quinazolinyl)piperazine, dihydrochloride | 60548-08-5 | C14H21Cl2N5O2 |
|
| 特布他林杂质4 | 3',5'-dibenzyloxy-ω-(benzyl-t-butylamino)-acetophenone | 52144-92-0 | C33H35NO3 |
|
| 特布他林杂质13 | 1-(4-bromo-3,5-dimethoxyphenyl)ethan-1-one | 1333472-28-8 | C10H11BrO3 |
|
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