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 |
|---|---|---|---|---|
| 1-[4-(4-氨基-6,7-二甲氧基-2-喹唑啉基)-1-哌嗪基]-5-羟基-1-戊酮 | Destetrahydrofuranyl-4-hydroxybutanyl terazosin | 109678-71-9 | C19H27N5O4 |
|
| 1-[4-(4-氨基-6,7-二甲氧基-2-喹唑啉基)-1-哌嗪基]-2-羟基-1-戊酮 | 1-(4-Amino-6,7-dimethoxyquinazolin-2-yl)-4-((2RS)-2-hydroxypentanoyl)piperazine | 152551-75-2 | C19H27N5O4 |
|
| 1-[3-(二甲基硝基r基)丙基]-1-(4-氟苯基)-1,3-二氢-2-苯并呋喃-5-甲腈 | (+)-Citalopram N-oxide | 917482-45-2 | C20H21FN2O2 |
|
| 1-[3-(二甲基氨基)丙基]-1-(4-氟苯基)-1,3-二氢-5-异苯并呋喃甲酰胺 | 1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carboxamide | 64372-56-1 | C20H23FN2O2 |
|
| 1-[3-(二甲基氨基)丙基]-1-(4-氟苯基)-1,3-二氢-3-氧代-5-异苯并呋喃甲腈 | 3-oxocitalopram | 372941-54-3 | C20H19FN2O2 |
|
| 1-[3-(4-叔丁基苯甲酰)丙基]-4-羟基哌啶 | 1-[4-(1,1-dimethylethyl)phenyl]-4-[4-hydroxy-1-piperidinyl]-1-butanone | 97928-18-2 | C19H29NO2 |
|
| 1-[3,5-二(苯基甲氧基)苯基]-2-溴乙烷-1-酮 | 3',5'-dibenzyloxy-α-bromoacetophenone | 28924-18-7 | C22H19BrO3 |
|
| 1-[3,5-二(苄氧基)苯基]-2-(叔丁基氨基)乙醇 | 1-[3,5-bis(benzyloxy)phenyl]-2-(tert-butylamino)ethanol | 28924-25-6 | C26H31NO3 |
|
| 1-[2-羟基-3-硝基-5-(苯基甲氧基)苯基]乙酮 | 1-[2-hydroxy-3-nitro-5-(benzyloxy)phenyl]ethanone | 861841-94-3 | C15H13NO5 |
|
| 1-[2-甲基氨基-1-(4-甲氧基苯基)乙基]环己醇 | N-Desmethylvenlafaxine | 149289-30-5 | C16H25NO2 |
|
| 1-[2-氰基-1-(氰基亚氨基)乙基]哌啶 | 3-Cyanimin-3-piperidin-propionitril | 56488-00-7 | C9H12N4 |
|
| 1-[2-氨基-1-(4-羟基苯基)乙基]环己醇 | (±)-O-desmethyl-N,N-didesmethylvenlafaxine | 149289-29-2 | C14H21NO2 |
|
| 1-[2-(二甲基氨基)-1-苯基乙基]环己醇 | 1-[2-(dimethylamino)-1-phenylethyl]cyclohexanol | 93413-86-6 | C16H25NO |
|
| 1-[2-(乙酰氧基)-6,7-二氢噻吩并[3,2-c]吡啶-5(4H)-基]-1-(3-氟苯基)-5-氯-2-戊酮 | 2-acetoxy-5-[5-chloro-1-(2-fluorophenyl)-2-oxopentyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridine | 1056459-37-0 | C20H21ClFNO3S |
|
| 1-[2-(2,4-二氟苯基)-2,3-环氧基丙基]-1H-1,2,4-噻唑 | 1-[2-(2,4-difluorophenyl)-2,3-epoxypropyl]-1H-1,2,4-triazole | 86386-76-7 | C11H9F2N3O |
|
| 1-[2,4-二氯代-β-[(3-噻吩甲基)-氧]苯乙基]咪唑盐酸盐 | 2-Deschlorothien-3-yl Tioconazole Hydrochloride | 61709-33-9 | C16H15Cl3N2OS |
|
| 1-[1-(4-苄氧基苯基)-2-(二甲基氨基)乙基]环己醇 | 1-[2-(dimethylamino)-1-(4-benzyloxyphenyl)ethyl]cyclohexanol | 93413-61-7 | C23H31NO2 |
|
| 1-[1-(4-氯苯基)环丁基]-3-甲基丁烷-1-酮 | 1-[1-(4-chloro-phenyl)cyclobutyl]-3-methyl-butan-1-one | 186521-85-7 | C15H19ClO |
|
| 1-[(2S)-3-溴-2-甲基-1-氧代丙基]-L-脯氨酸 | 1-(3-bromo-2S-methylpropionyl)-pyrrolidine-2S-carboxylic acid | 80629-35-2 | C9H14BrNO3 |
|
| 1-[(2-氟苯基)甲基]-1H-吡唑并[3,4-b]吡啶-3-羧酰胺 | 1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-carboxamide | 256376-62-2 | C14H11FN4O |
|
| 1-Boc-4-(5-硝基-2-吡啶基)哌嗪 | tert-butyl 4-(5-nitropyridin-2-yl)piperazine-1-carboxylate | 193902-78-2 | C14H20N4O4 |
|
| 1-BOC-4-(2-氨基-4-吡啶基)哌嗪 | tert-butyl 4-(2-aminopyridin-4-yl)piperazine-1-carboxylate | 571189-23-6 | C14H22N4O2 |
|
| 1-(苯基氨基甲酰基)环丙烷-1-羧酸 | 1-(phenylcarbamoyl)cyclopropane-1-carboxylic acid | 145591-80-6 | C11H11NO3 |
|
| 1-(溴苯甲基)-4-氯苯 | 4-chlorobenzhydryl bromide | 948-54-9 | C13H10BrCl |
|
| 1-(氯甲基)-4-(二氯甲基)苯 | 1-chloromethyl-4-dichloromethyl-benzene | 7398-44-9 | C8H7Cl3 |
|
| 1-(异丙基氨基)-3-(2-(2-甲氧基乙基)苯氧基)丙烷-2-醇 | 1-isopropylamino-3-[2-(2-methoxyethyl)phenoxy]-2-propanol | 163685-38-9 | C15H25NO3 |
|
| 1-(二甲氧基甲基)-3-甲氧基苯 | m-anisaldehyde dimethyl acetal | 59276-28-7 | C10H14O3 |
|
| 1-(乙基氨基)-3-[4-(2-甲氧基乙基)苯氧基]-2-丙醇 | 1-(Ethylamino)-3-(4-(2-methoxyethyl)phenoxy)propan-2-ol | 109632-08-8 | C14H23NO3 |
|
| 1-(o-烯丙基苯氧基)-3-(异丙基氨基)-2-丙醇 盐酸盐 | alprenolol hydrochloride | 13707-88-5 | C15H23NO2*ClH |
|
| 1-(P-甲苯磺酰基)高哌嗪 | 1-(4-Methylphenyl)sulfonyl-1,4-diazepane | 872103-28-1 | C12H18N2O2S |
|
| 1-(7-苯并[B]噻吩基)哌嗪 | 1-(benzo[b]thiophen-7-yl)piperazine | 105685-06-1 | C12H14N2S |
|
| 1-(6-甲基吡啶-3-基)-2-(4-(甲硫基)苯基)乙酮 | 1-(6-methyl-3-pyridinyl)-2-[4-(methyl sulfide)phenyl]ethanone | 221615-72-1 | C15H15NOS |
|
| 1-(5-异喹啉基磺酰)哌嗪二盐酸盐 | (5-isoquinolinylsulfonyl)piperazine | 84468-24-6 | C13H15N3O2S |
|
| 1-(4-羟基苯基)丙-2-烯-1-酮 | 1-(4-hydroxyphenyl)prop-2-en-1-one | 95605-38-2 | C9H8O2 |
|
| 1-(4-羟基苯基)-7-氧代-6-(4-(2-氧代-1-哌啶基)苯基)-4,5,6,7-四氢-1H-吡唑并[3,4-c]吡啶-3-羧酰胺 | O-Demethylapixaban | 503612-76-8 | C24H23N5O4 |
|
| 1-(4-硝基苯)-1H-吡啶-2-酮 | 1-(4-nitrophenyl)pyridin-2(1H)-one | 53427-97-7 | C11H8N2O3 |
|
| 1-(4-甲氧基苯基)-7-氧代-6-[4-(2-氧代哌啶-1-基)苯基]-4,5,6,7-四氢-1H-吡唑并[3,4-c]吡啶-3-羧酸 | 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylic acid | 503614-92-4 | C25H24N4O5 |
|
| 1-(4-甲氧基苯基)-2-甲基丙烷-2-醇 | 1-(4-methoxyphenyl)-2-methylpropan-2-ol | 35144-39-9 | C11H16O2 |
|
| 1-(4-甲氧基苯基)-2-甲基丙烷-2-胺 | 1-(2-amino-2-methylpropyl)-4-methoxybenzene | 56490-94-9 | C11H17NO |
|
| 1-(4-氯苯甲酰基)-5-甲氧基-2-甲基-1H-吲哚-3-乙酸2,3-二羟基丙基酯 | indomethacin-α-monoglyceride | 71848-87-8 | C22H22ClNO6 |
|
| 1-(4-氯二苯甲基)哌嗪 | N-(4-chlorobenzhydryl)piperazine | 303-26-4 | C17H19ClN2 |
|
| 1-(4-氯-3-(三氟甲基)苯基)-3-(4-羟基苯基)脲 | 1-(4-chloro-3-(trifluoromethyl)phenyl)-3-(4-hydroxyphenyl)urea | 1129683-83-5 | C14H10ClF3N2O2 |
|
| 1-(4-氨基-6-羟基-7-甲氧基-2-喹唑啉基)-4-[(四氢-2-呋喃基)羰基]哌嗪 | 6-O-Desmethyl terazosin | 105356-89-6 | C18H23N5O4 |
|
| 1-(4-氟苯基)-1-(3-二甲基氨基丙基)-5-氯二氢异苯并呋喃 | Lu 10-134-C | 64169-45-5 | C19H21ClFNO |
|
| 1-(4-氟苯基)-1,3-二氢-1-[3-(甲基氨基)丙基]异苯并呋喃-5-甲腈 | rac-desmethylcitalopram | 62498-67-3 | C19H19FN2O |
|
| 1-(4-乙基苯基)-2-甲基丙-2-烯-1-酮 | 4'-ethyl-2-methylacrylophenone | 70639-76-8 | C12H14O |
|
| 1-(3-羟基苯基)-2-[甲基(苯甲基)氨基]乙酮盐酸盐 | 3-Hydroxyphenyl-ω-methylbenzylaminoacetophenone | 71786-67-9 | C16H17NO2*ClH |
|
| 1-(3-氰基吡啶-2)-2-苯基-4-甲基哌嗪 | 1-(3-cyanopyridyl-2)-2-phenyl-4-methylpiperazine | 61337-88-0 | C17H18N4 |
|
| 1-(3-氯苯基)-2-羟基-1-丙酮 | 1-(3-chlorophenyl)-2-hydroxypropan-1-one | 152943-33-4 | C9H9ClO2 |
|
| 1-(3-氯苯基)-1-羟基-2-丙酮 | 1-(3-chlorophenyl)-1-hydroxy-2 propanone | 857233-13-7 | C9H9ClO2 |
|
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