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 |
|---|---|---|---|
| 1,3-二氧代-2-异吲哚啉乙酸 | 3-acetylaminophthalic anhydride | 6296-53-3 | C10H7NO4 |
| 1,3-二氢-6-甲基-呋喃并[3,4-c]吡啶-7-醇 | 7-hydroxy-6-methyl-1,3-dihydrofuro<3,4-c>pyridin | 5196-20-3 | C8H9NO2 |
| 1,3-二氢-4-甲基-2H-1,5-苯并二氮杂革-2-酮 | 4-methyl-2,3-dihydro-1H-1,5-benzodiazepin-2-one | 6276-48-8 | C10H10N2O |
| 1,3-二氢-4-(2-羟乙基)-2H-吲哚-2-酮 | 4-(2-hydroxyethyl)indolin-2-one | 139122-19-3 | C10H11NO2 |
| 1,3-二乙基-1,3-二甲基脲 | 1,3-Diethyl-1,3-dimethylurea | 31468-19-6 | C7H16N2O |
| 1,3-二丙基脲 | 1,3-dipropylurea | 623-95-0 | C7H16N2O |
| 1,3-二[4-(2-甲氧基乙基)苯氧基]-2-丙醇 | 1,3-di-(4-(2-methoxy)ethylphenyl)oxy-2-propanol | 230975-30-1 | C21H28O5 |
| 1,3-二-HABA卡那霉素A | 1,3-Di-HABA Kanamycin A | 927821-99-6 | C26H50N6O15 |
| 1,3-二(9H-咔唑-4-基氧基)-2-丙醇 | 1,3-Bis[(9H-carbazol-4-yl)oxy]propan-2-ol | 1276477-91-8 | C27H22N2O3 |
| 1,3,5,7-四羟基金刚烷 | 1,3,5,7-tetrahydroxyadamantane | 16104-28-2 | C10H16O4 |
| 1,3,5,7-四甲基金刚烷 | 1,3,5,7-tetramethyladamantane | 1687-36-1 | C14H24 |
| 1,2-二氢泼尼卡酯 | 1,2-Dihydro Prednicarbate | 671225-26-6 | C27H38O8 |
| 1,2-二氢倍氯米松二丙酸酯 | 9α-Chloro-11β,17α,21-trihydroxy-16β-methylpregn-4-ene-3,20-dione 17,21-dipropionate | 114371-33-4 | C28H39ClO7 |
| 1,2-二氢-6,7-二甲基-2-酮-1-核糖醇-3-喹喔啉羧酸 | 6,7-dimethyl-3-oxo-4-((2S,3S,4R)-2,3,4,5-tetrahydroxypentyl)-3,4-dihydroquinoxaline-2-carboxylic acid | 64480-68-8 | C16H20N2O7 |
| 1,2-二氢-2-氧代-3-氰基吡嗪 | 3-cyano-2(1H)-pyrazinone | 81411-78-1 | C5H3N3O |
| 1,2-二(2-甲氧基苯氧基)乙烷 | 1,2-bis(2’-methoxyphenoxy)ethane | 553-45-7 | C16H18O4 |
| 1,2,4-三甲氧基-5-丙-2-烯基苯 | 1-allyl-2,4,5-trimethoxybenzene | 5353-15-1 | C12H16O3 |
| 1,2,3,9-四氢-3-[(2-甲基-1H-咪唑-1-基)甲基]-4H-咔唑-4-酮 | N-Desmethylondansetron | 99614-14-9 | C17H17N3O |
| 1,2,3,9-四氢-3-(1H-咪唑-1-基甲基)-9-甲基-4H-咔唑-4-酮 | c-Desmethylondansetron | 99614-03-6 | C17H17N3O |
| 1,2,3,4-四氢-4,8-二羟基-2-甲基-异喹啉 | Longimammamin | 23824-25-1 | C10H13NO2 |
| 1,2,3,4,10,14b-六氢-2-甲基-吡嗪并[2,1-a]吡啶并[2,3-c][2]苯并氮杂卓-8-醇 | 8-Hydroxy-Mirtazapine | 102335-57-9 | C17H19N3O |
| 1,1,1-三氯-2,2,2-三甲氧基乙烷 | Trimethyl orthotrichloroacetate | 19932-79-7 | C5H9Cl3O3 |
| 1,1'-联(环己烷)-1'-烯-2-胺 | cyclohexanone N-cyclohexylimine | 10468-40-3 | C12H21N |
| 1,1'-[1,3-丙烷二基二(氧基)]二[2,5-二甲基苯] | 2-[3-(2,5-Dimethylphenoxy)propoxy]-1,4-dimethylbenzene | 415724-02-6 | C19H24O2 |
| 1,1'-(4,4'-二甲氧基[1,1'-联苯]-3,3'-二基)二金刚烷 | 3,3'-diadamantyl-4,4'-dimethoxybiphenyl | 932033-57-3 | C34H42O2 |
| 1,1'-(1,1-乙二基)二(4-异丁基苯) | 1,1-Bis(p-isobutylphenyl)ethane | 102120-87-6 | C22H30 |
| 1'',16-环氧红霉素 | Erythromycin E | 41451-91-6 | C37H65NO14 |
| (外消旋,顺式)-4-去氯-舍曲林 | cis-(1S,4S)-N-methyl-(3-chlorophenyl)-1,2,3,4-tetrahydro-1-naphtalenamine | 871838-58-3 | C17H18ClN |
| (反式)-4-丙基-1-甲基-L-脯氨酸 | 1-Methyl-4t-n-propyl-L-prolin | 13380-36-4 | C9H17NO2 |
| (二甲氨基)乙醛缩二甲醇 | dimethylaminoacetaldehyde dimethyl acetal | 38711-20-5 | C6H15NO2 |
| (±)-普拉克索 | 2-amino-4,5,6,7-tetrahydro-6-propylaminobenzothiazole | 104617-86-9 | C10H17N3S |
| (±)-1,2-二苯基-1-[4-[2-(二甲基氨基)乙氧基]苯基]丁烷-1-醇 | 1-(4-(2-(dimethylamino)ethoxy)phenyl)-1,2-diphenylbutan-1-ol | 748-97-0 | C26H31NO2 |
| (betaR,deltaR)-beta,delta-二羟基-2-异丙基-4,5-二苯基-3-[(苯基氨基)羰基]-1H-吡咯-1-庚酸 | (3R,5R)-3,5-dihydroxy-7-(2-isopropyl-4,5-diphenyl-3-phenylcarbamoyl-pyrrol-1-yl)-heptanoic acid | 433289-84-0 | C33H36N2O5 |
| (alphaZ)-alpha-(甲氧基亚胺)-N-[(5aR,6R)-1,4,5a,6-四氢-1,7-二氧代-3H,7H-氮杂环丁烷并[2,1-b]呋喃并[3,4-d][1,3]噻嗪-6-基]-2-呋喃乙酰胺 | cefuroxime lactone | 947723-87-7 | C15H13N3O6S |
| (alphaS)-alpha-氨基-N-[(1R)-1-[(3aS,4S,6S,7aR)-六氢-3a,5,5-三甲基-4,6-甲桥-1,3,2-苯并二氧硼烷-2-基]-3-甲基丁基]苯丙酰胺盐酸盐 | 2-amino-N-((R)-3-methyl-1-((3aS,4S,6R,7aR)-3a,5,5-trimethylhexahydro-4,6-methanobenzo[d][1,3,2]dioxaborol-2-yl)butyl)-3-phenylpropanamide hydrochloride | 205393-21-1 | C24H37BN2O3*ClH |
| (alphaS)-alpha-乙基-2,5-二氢-2-氧代-4-丙基-1H-吡咯-1-乙酰胺 | (2S)-2-(2-oxo-4-propyl-2,5-dihydro-1H-pyrrol-1-yl)butanamide | 357338-13-7 | C11H18N2O2 |
| (alphaS)-3-甲氧基-N,N,alpha-三甲基苯甲胺 | (S)-1-(3-methoxyphenyl)-N,N-dimethylethanamine | 889443-69-0 | C11H17NO |
| (alphaE)-alpha-[(3,4-二羟基-5-硝基苯基)亚甲基]-beta-氧代-1-哌啶丙腈 | (E)-3-(3,4-dihydroxy-5-nitrophenyl)-2-(piperidine-1-carbonyl)acrylonitrile | 1150310-15-8 | C15H15N3O5 |
| (alpha1S,alpha4S,2S,5S)-2,5-二甲基-3,6-二氧代-alpha1,alpha4-二(2-苯基乙基)-1,4-哌嗪二乙酸1,4-二乙酯 | N,N'-bis<1'-(S)-1-carboethoxy-3'-phenylpropyl>-3,6-(S)-dimethyl-2,5-diketopiperazine | 151387-05-2 | C30H38N2O6 |
| (Z,E,Z)-9,11,13-十八碳三烯酸 | 9-cis,11-trans,13-cis-octadecatrienoic acid | 544-72-9 | C18H30O2 |
| (Z)-桂利嗪 | (Z)-1-(diphenylmethyl)-4-cinnamylpiperazine | 750512-44-8 | C26H28N2 |
| (Z)-2-甲基-2-丁烯酸[(1S,2R,7aR)-六氢-2beta-羟基-1H-吡咯里嗪-1beta-基]甲基酯 | Macrophylline | 27841-97-0 | C13H21NO3 |
| (Z)-2-(2-氨基噻唑-4-基)-2-(羟基亚胺)-N-{[(2RS,5RS)-5-甲基-7-氧代-2,4,5,7-四氢-1H-呋喃并[3,4-d][1,3]噻嗪-2-基]甲基}乙酰胺 | Cefdinir impurity H | 178949-04-7 | C13H15N5O4S2 |
| (V)二(4-氯苯醇酸根)(氢三(3,5-二甲基-1-吡唑基)硼酸根)羰基钼 | Glyasperin C | 142474-53-1 | C21H24O5 |
| (S,Z)-3-(((((1R,3AR,3'R,4R,7AR)-7A-甲基-1-((R)-6-甲基庚基-2-基)八氢螺][茚-4,2'-环氧乙烷]-3'-基)亚甲基)-4-亚甲基环己-1-醇 | (7R)-7,8-epoxy-9,10-seco-5,10(19)-cholestadien-3β-ol | 89231-90-3 | C27H44O2 |
| (S)-羟基去(硼酸)硼替佐米 | Pyrazine-2-carboxylic acid [(S)-1-((S)-1-hydroxy-3-methyl-butylcarbamoyl)-2-phenyl-ethyl]-amide | 289472-81-7 | C19H24N4O3 |
| (S)-托特罗定 | (S)-tolterodine | 124937-53-7 | C22H31NO |
| (S)-奥达特罗 | (S)-6-hydroxy-8-(1-hydroxy-2-(1-(4-methoxyphenyl)-2-methylpropan-2-ylamino)ethyl)-2H-benzo[b][1,4]oxazin-3(4H)-one | 868049-50-7 | C21H26N2O5 |
| (S)-吡咯烷-2-腈 | (S)-pyrrolidine-2-carbonitrile | 204387-53-1 | C5H8N2 |
| (S)-N-二去甲基达泊西汀 | (R)-1-phenyl-3-(naphthyl-1-oxy)propylamine tartrate | 147199-40-4 | C19H19NO |