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 |
|---|---|---|---|---|
| 氯吡格雷EP杂质E(R-异构体) | (+)-(S)-2-chlorophenyl-(6,7-dihydro-4H-thieno[3,2-c]pyridin-5-yl)acetamide | 444728-15-8 | C15H15ClN2OS |
|
| 氯卡色林杂质D | 2-(4-chlorophenyl)-N-(2-hydroxypropyl)acetamide | 1030624-36-2 | C11H14ClNO2 |
|
| 氯化(2R)-3-羧基-N,N,N-三甲基-2-[(硫烷基乙酰基)氧代]丙烷-1-铵 | 5H-Dibenz(b,f)azepin-1-ol, 7-chloro-5-(3-(dimethylamino)propyl)-10,11-dihydro- | 83385-97-1 | C19H23ClN2O |
|
| 氯丙嗪杂质B | 2-chloro-10-(3-(N-(3-dimethylamino)propyl-N-methyl)amino)propyl-10H-phenothiazine | 19077-20-4 | C21H28ClN3S |
|
| 氮卓斯汀氮氧化物 | Azelastine N-oxide | 640279-88-5 | C22H24ClN3O2 |
|
| 氮卓斯汀杂质17 | ethyl 4-(N-(2-ethoxycarbonylethyl)-N-methyl)aminobutyrate | 109386-70-1 | C12H23NO4 |
|
| 氨苄青霉素杂质15 | the penicilloic acid of ampicillin | 32746-94-4 | C16H21N3O5S |
|
| 氨苄青霉素EP杂质M | Ampicillin Trimer Trisodium Salt | 114977-84-3 | C48H57N9O12S3 |
|
| 氨苄西林钠杂质K | (2R)-[(2,2-dimethylpropanoyl)amino](phenyl)acetic acid | 40610-41-1 | C13H17NO3 |
|
| 氨苄西林杂质J | (2S,5R,6R)-6-((2,2-Dimethylpropanoyl)amino)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic acid | 6489-58-3 | C13H20N2O4S |
|
| 氨苄西林杂质 | α-[[[(2S,5R,6R)-6-[[(2R)-2-amino-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]hept-2-yl]carbonyl]amino] | 1207726-28-0 | C24H26N4O5S |
|
| 氨磺必利杂质4 | 4-amino-5-ethylthio-2-methoxybenzoic acid methyl ester | 1119455-01-4 | C11H15NO3S |
|
| 氨磺必利杂质16 | methyl 5-ethylthio-2-methoxy-4-methylaminobenzoate | 483304-04-7 | C12H17NO3S |
|
| 氨磺必利杂质14 | methyl 5-cyanothio-2-methoxy-4-methylaminobenzoate | 483304-03-6 | C11H12N2O3S |
|
| 氨磺必利杂质 | 4-amino-N-[(1-ethyl-2-pyrrolidinyl)methyl]-N-[methyl]-5-(ethylsulfonyl)-2-methoxybenzamide | 1391054-22-0 | C18H29N3O4S |
|
| 氨磺必利杂质 | 1-Ethyl-2,2-dimethoxypyrrolidine | 84859-26-7 | C8H17NO2 |
|
| 氨磺必利N-氧化物 | Amisulpride N-Oxide | 71676-01-2 | C17H27N3O5S |
|
| 氨磷汀相关杂质2 | 1-[N,N-bis(2-aminopropyl)amino]-1-propanol | 17002-55-0 | C8H21N3O |
|
| 氨磷汀杂质7 | N,N'-bis(2-bromoethyl)-1,3-propanediamine | 174397-83-2 | C7H16Br2N2 |
|
| 氨溴索杂质I | 4-(2-amino-3,5-dibromobenzylamino)cyclohexanone | 1445719-53-8 | C13H16Br2N2O |
|
| 氨氯地平杂质H | 2-Carboxybenzoyl Amlodipine | 318465-73-5 | C28H29ClN2O8 |
|
| 氨氯地平杂质48 | 5-ethyl 3-methyl 4-(2-chlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate | 39562-06-6 | C18H20ClNO4 |
|
| 氨氯地平杂质29 | N-acetylamlodipine | 93848-82-9 | C22H27ClN2O6 |
|
| 氨氯地平杂质28 | 4-(2-chlorophenyl)-3-ethoxycarbonyl-2-hydroxymethyl-6-methyl-1,4-dihydropyridine | 79781-21-8 | C18H20ClNO5 |
|
| 氨氯地平杂质20 | diethyl 2,6-dimethyl-4-(2-chlorophenyl)-1,4-dihydropyridine-3,5-dicarboxylate | 34148-67-9 | C19H22ClNO4 |
|
| 氨氯地平杂质 | diethyl 2,6-bis[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-3,5-pyridinedicarboxylate | 331258-31-2 | C23H32ClN3O6 |
|
| 氨氯地平天冬氨酸杂质 | Amlodipine Maleate Adduct | 400602-35-9 | C24H29ClN2O9 |
|
| 氨氯地平-D4 | Amlodipine-d4 | 1185246-14-3 | C20H25ClN2O5 |
|
| 氨曲南脱磺基杂质 | Desulfated Aztreonam | 102579-59-9 | C13H17N5O5S |
|
| 氨曲南杂质F | aztreonam ethyl ester | 102579-57-7 | C15H21N5O8S2 |
|
| 氨曲南杂质37 | [3S-[3α(Z),4β]]-3-[[(2-amino-4-miazolyl)[1-t-butoxycarbonyl-1-methylethoxyimino]acetyl]amino]-4-methyl-2-oxo-1-azetidinesulfonic acid | 330944-50-8 | C17H25N5O8S2 |
|
| 氨曲南开环脱磺基杂质 | Open-ring desulfated aztreonam | 102586-36-7 | C13H19N5O6S |
|
| 氨基磺酰氧基乙烷 | ethylsulfamate ester | 4403-49-0 | C2H7NO3S |
|
| 氧氯丙嗪 | chlorpromazine sulfoxide | 969-99-3 | C17H19ClN2OS |
|
| 氧氟沙星EP杂质D | 9-Piperazino Ofloxacin | 197291-75-1 | C18H20FN3O4 |
|
| 氧氟沙星EP杂质C | 3-Methyl-9-(4-methyl-piperazin-1-yl)-6-oxo-2,3-dihydro-6H-1-oxa-3a-aza-phenalene-5-carboxylic acid | 95848-94-5 | C18H21N3O4 |
|
| 氢醌杂质14 | [1,1′-biphenyl]-2,2′,4,4′,5,5′-hexaol | 76625-61-1 | C12H10O6 |
|
| 氢化可的松杂质D | 6β,11β,17α,21‐tetrahydroxypregen‐4‐ene‐3,20‐dione | 53-35-0 | C21H30O6 |
|
| 氟骨三醇 | Falecalcitriol | 83805-11-2 | C27H38F6O3 |
|
| 氟马西尼杂质 | ethyl 5,6-dihydro-5-methyl-6-oxo-4H-imidazo[1,5-a][ 1,4]benzodiazepine-3-carboxylate | 78756-03-3 | C15H15N3O3 |
|
| 氟达拉滨杂质 | 9-β-D-Arabinofuranosyl-2-methoxyadenin | 51742-84-8 | C11H15N5O5 |
|
| 氟达拉滨EP杂质H | 9-(2,5-anhydro-β-D-arabinofuranyl)-2-fluoro-9H-purin-6-amine | 548774-57-8 | C10H10FN5O3 |
|
| 氟维司群杂质4 | Fulvestrant Impurity 4 | 1621885-82-2 | C30H44O6S |
|
| 氟米龙杂质 | Methanesulfonic acid 2-((6S,9R,11S,17R)-9-fluoro-11,17-dihydroxy-6,10,13-trimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl)-2-oxo-ethyl ester | 2796-99-8 | C23H31FO7S |
|
| 氟米松新戊酸酯 | flumethasone pivalate | 2002-29-1 | C27H36F2O6 |
|
| 氟班色林杂质8 | 1,3-bis(2-chloroethyl)benzimidazolin-2-one | 55470-74-1 | C11H12Cl2N2O |
|
| 氟班色林杂质 | Bis-(m-trifluormethylphenyl-4-piperazinyl)-1,2-ethan | 51299-16-2 | C24H28F6N4 |
|
| 氟氧头孢杂质5 | (6R,7R)-benzhydryl (7-(2-difluoromethylthio)acetamido)-3-(chloromethyl)-7-methoxy-8-oxo-5-oxa-1-aza-bicyclo[4,2,0]oct-2-ene-2-carboxylate | 134237-56-2 | C25H23ClF2N2O6S |
|
| 氟比洛芬杂质L | flurbiprofen ethyl ester | 64858-90-8 | C17H17FO2 |
|
| 氟比洛芬杂质F | 1-ethyl-3-fluoro-4-phenylbenzene | 55258-76-9 | C14H13F |
|
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