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 |
---|---|---|---|---|
二叶草素 | diphyllin | 22055-22-7 | C21H16O7 |
|
二丁基丙基膦酸酯 | 3,4-dichlorobenzylamine hydrochloride | 49552-34-3 | C7H7Cl2N*ClH |
|
二(氨基乙氧基)氨氯地平 | ethylmethyl-2,6-bis-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydropyridine-3,5-dicarboxylate | 721958-74-3 | C22H30ClN3O6 |
|
二(2,4-二甲苯基)二硫醚 | 1,2-bis(2,4-dimethylphenyl)disulfane | 13616-83-6 | C16H18S2 |
|
乙酰胺,N-[4-(1,4,5,6-四氢-4-甲基-6-羰基-3-哒嗪基)苯基]-,(R)- | OR-1896 | 139052-02-1 | C13H15N3O2 |
|
乙酰水杨酰水杨酸 | acetylsalicylsalicylic acid | 530-75-6 | C16H12O6 |
|
乙酰氨基嘌呤 | N6-Acetyladenine | 6034-68-0 | C7H7N5O |
|
乙酰基纤维素 | Cellulose acetate phthalate | 9004-38-0 | C32H34O19 |
|
乙酰基可乐定 | 1-acetyl-2-(2,6-dichloro-anilino)-4,5-dihydro-1<i>H</i>-imidazole | 54707-71-0 | C11H11Cl2N3O |
|
乙羟茶碱 | 7-(2-hydroxyethyl)theophylline | 519-37-9 | C9H12N4O3 |
|
乙烷磺酸乙酯 | ethyl ethanesulfonate | 1912-30-7 | C4H10O3S |
|
乙基香兰素-D-葡萄糖 | (4-formyl-2-ethoxyphenyl) β-D-glucopyranoside | 122397-96-0 | C15H20O8 |
|
乙基异丙基亚硝胺 | ethyl-isopropyl-nitroso-amine | 16339-04-1 | C5H12N2O |
|
乙基三苯甲基醚 | Triphenylmethylethylether | 968-39-8 | C21H20O |
|
乙基4-[8-氯-4-(羟基甲基)-5,6-二氢-11H-苯并[5,6]环庚并[1,2-b]吡啶-11-亚基]-1-哌啶羧酸酯 | 4-(hydroxymethyl)loratadine | 609806-40-8 | C23H25ClN2O3 |
|
乙基4-(8-氯-3-羟基-5,6-二氢-11H-苯并[5,6]环庚并[1,2-b]吡啶-11-亚基)-1-哌啶羧酸酯 | 3-hydroxyloratadine | 183483-15-0 | C22H23ClN2O3 |
|
乙基3-氧代-2-丙基庚酸酯 | 2-Valeryl-valeriansaeure-ethylester, 2-Propyl-3-oxo-heptansaeure-ethylester | 96610-56-9 | C12H22O3 |
|
乙基3-(4-甲基苯基)-2-丙炔酸酯 | ethyl 3-(4-methylphenyl)prop-2-ynoate | 52188-06-4 | C12H12O2 |
|
乙基2-环己基-2-羟基苯乙酸酯 | ethyl 2-cyclohexyl-2-hydroxy-2-phenylacetate | 31197-69-0 | C16H22O3 |
|
乙基2-(3-氰基-4-异丁氧基苯基)-4-甲基-1,3-噻唑-5-羧酸酯 | ethyl 2-(4-isobutoxyphenyl)-4-methylthiazole-5-carboxylate | 144060-97-9 | C17H21NO3S |
|
乙基(2S,4S)-4-甲基哌可酸酯 | ethyl (2S,4S)-4-methylpipecolate | 78306-52-2 | C9H17NO2 |
|
乙基(2S,4R)-4-甲基哌可酸酯 | (2S,4R)-4-methyl-2-piperidinecarboxylic acid ethyl ester | 79199-62-5 | C9H17NO2 |
|
乙基(2E)-3-[4-(溴甲基)苯基]丙烯酸酯 | ethyl 4-bromomethylcinnamate | 78712-67-1 | C12H13BrO2 |
|
乐卡地平杂质A | Lercanidipine Impurity A | 74936-74-6 | C19H22N2O6 |
|
乐伐替尼杂质IIA-6 | 4-chloro-7-methoxyquinoline-6-carboxylic acid | 771464-30-3 | C11H8ClNO3 |
|
乐伐替尼杂质D | O-desmethyl lenvatinib | 417717-04-5 | C20H17ClN4O4 |
|
乌帕替尼杂质4 | benzyl (3R,4S)-3-(N-(tert-butoxycarbonyl)-N-(5-tosyl-5H-pyrrolo[2,3-b]pyrazin-2-yl)glycyl)-4-ethylpyrrolidine-1-carboxylate | 1428243-27-9 | C34H39N5O7S |
|
丹曲林杂质B | 2-[Carbamoyl-[[5-(4-nitrophenyl)furan-2-yl]methylideneamino]amino]acetic acid | 57268-33-4 | C14H12N4O6 |
|
丙环定盐酸盐 | Procyclidine hydrochloride | 1508-76-5 | C19H29NO*ClH |
|
丙氧苯基硫代西地那非 | Propoxyphenyl thiosildenafil | 479073-87-5 | C23H32N6O3S2 |
|
丙戊酸相关物质A | 2-allyl-4-pentenoic acid | 99-67-2 | C8H12O2 |
|
丙戊酸杂质B 2,2-二-正丙基乙酸 | propylisopropyl acetic acid | 62391-99-5 | C8H16O2 |
|
丙基丙氨酸酯 | L-alanine n-propyl ester | 58989-06-3 | C6H13NO2 |
|
丙卡特罗杂质4 | 5-(2-methylisopropylaminobutyryl)-8-hydroxyquinolone | 63235-39-2 | C16H20N2O3 |
|
丙二醇二月桂酸酯 | propylene glycol monolaurate | 22788-19-8 | C27H52O4 |
|
三苯甲基洛沙坦 | trityl losartan | 133909-99-6 | C41H37ClN6O |
|
三芳基丁二烯 | (Z)-2-(4-(1,2-diphenylbuta-1,3-dien-1-yl)phenoxy)-N,N-dimethylethanamine | 604010-60-8 | C26H27NO |
|
三氯氨络铂(II)酸钾 | Potassium trichloroammineplatinate | 13820-91-2 | Cl3H3NPt*K |
|
三氮唑核苷羧酸 | ICN3297 | 39925-19-4 | C8H11N3O6 |
|
三氮唑杂质1 | 1,2,4-Triazolo(3,4-b)benzothiazole-5-methanol | 69243-49-8 | C9H7N3OS |
|
三乙酰基芦荟大黄素 | triacetyl aloe-emodin | 25395-11-3 | C21H16O8 |
|
三(2-甲基苯基)-氧膦 | tri-o-tolylphosphine oxide | 6163-63-9 | C21H21OP |
|
丁酸氯维地平杂质H324/78 | butyroxymethyl methyl 4-(2',3'-dichlorophenyl)-2,6-dimethyl-3,5-pyridinedicarboxylate | 188649-48-1 | C21H21Cl2NO6 |
|
丁酸倍氯他松 | Clobetasone butyrate | 25122-57-0 | C26H32ClFO5 |
|
丁苯酞杂质43 | (R)-2-(1-hydroxybutyl)benzoic acid | 952412-99-6 | C11H14O3 |
|
丁苯酞杂质27 | Aethyl-(2-carboxybenzoyl)acetat | 33704-16-4 | C12H12O5 |
|
丁苯酞杂质 | 2-hexanoyl-benzoic acid | 857538-11-5 | C13H16O3 |
|
丁苯酞杂质 | 2-(pent-1-en-1-yl)benzoic acid | 16692-58-3 | C12H14O2 |
|
丁苯酞杂质 | 3-pentylbenzo[c]furan-1(3H)-one | 111943-62-5 | C13H16O2 |
|
丁苯酞杂质 | 2-Butyryl-benzoesaeure | 19666-03-6 | C11H12O3 |
|