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 |
---|---|---|---|---|
丁苯酞杂质 | 3-ethylphthalide | 17475-41-1 | C10H10O2 |
|
丁苯酞杂质 | 2-(1-hydroxypentyl)benzoic acid | 380905-48-6 | C12H16O3 |
|
丁苯酞杂质 | 2-propylindan-1,3-dione | 14570-43-5 | C12H12O2 |
|
丁胺卡那霉素杂质A | (2S)-4-amino-N-[(1S,2R,3R,4S,5R)-5-amino-4-[(2S,3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-2-[(2R,3R,4S,5S,6R)-6-(aminomethyl)-3,4,5-trihydroxyoxan-2-yl]oxy-3-hydroxycyclohexyl]-2-hydroxybutanamide | 50725-24-1 | C22H43N5O13 |
|
丁烷-1-磺酸甲酯 | butane-1-sulfonic acid methyl ester | 2374-69-8 | C5H12O3S |
|
丁溴东莨菪碱杂质05 | 3-hydroxy-2-phenyl-propionic acid 9-butyl-3-oxa-9-aza-tricyclo[3.3.1.0<sup>2,4</sup>]non-7-yl ester | 14861-14-4 | C20H27NO4 |
|
丁溴东莨菪碱杂质04 | (1r,2r,4s,5s,7s,9s)-7-(((s)-3-hydroxy-2-phenylpropanoyl)oxy)-9-methyl-9-propyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-9-ium | 30269-50-2 | Br*C20H28NO4 |
|
丁溴东莨菪碱EP杂质E | N-Butyl Nor Scopolamine Hydrochloride | 22235-98-9 | C20H28ClNO4 |
|
丁内未利葡萄糖苷 | Tinnevellin glucoside | 80358-06-1 | C20H24O9 |
|
丁乙酸氢化泼尼松 | Prednisolone Tebutate | 7681-14-3 | C27H38O6 |
|
一元羧基哌啶子酸 | Monodecarboxy Piperacilloic Acid | 64817-23-8 | C22H29N5O6S |
|
α,α'-双[[(2-甲氧基苯氧基)甲基]-1,4-哌嗪二乙醇 | 1-{4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-piperazin-1-yl}-3-(2-methoxyphenoxy)propan-2-ol | 333749-57-8 | C24H34N2O6 |
|
α-羟基奥洛帕定盐酸盐 | alpha-Hydroxy olopatadine | 1331668-21-3 | C21H24ClNO4 |
|
α-甲基多巴甲基酯 | L-methyldopa methyl ester | 18181-08-3 | C11H15NO4 |
|
α-[2-(二甲基氨基)-1-甲基乙基]-α-苯基苯乙醇-1-乙酸酯 | α-2-Acetoxy-4-dimethylamino-3-methyl-1,2-diphenyl-butan | 53990-51-5 | C21H27NO2 |
|
α-D-葡庚糖酸钙盐 | D-glycero-D-gulo-Heptonic acid, calcium salt (2:1) | 17140-60-2 | C7H14CaO8 |
|
Γ-山椒素 | (2E,4E,8Z,10E,12E)-N-isobutyl tetradeca-2,4,8,10,12-pentaenamide | 78886-65-4 | C18H27NO |
|
Α-去甲基阿那曲唑 | alpha-Desmethyl Anastrozole | 1215780-15-6 | C16H17N5 |
|
Α-(2,4-二氟苯基)-5-氟-Β-甲基-Α-(1,2,4-三唑-1-甲基)-4-嘧啶乙醇 | voriconazole | 137234-63-0 | C16H14F3N5O |
|
s-2-氨基-6-丙酰氨基-4,5,6,7-四氢苯并噻唑 | (S)-2-amino-6-propionamido-4,5,6,7-tetrahydrobenzothiazole | 106006-84-2 | C10H15N3OS |
|
rel-(6R,9aS)-八氢-3-氧代-2,6-甲桥-2H-喹嗪-8-基1H-吲哚-3-羧酸酯甲烷磺酸盐水合物 | Unii-U3C8E5bwkr | 878143-33-0 | C20H26N2O7S |
|
rel-(1R,3S,5S)-8-甲基-8-氮杂双环[3,2,1]辛-6-烯-基-2-羟基-2,2-二噻吩-2-基乙酸酯 | rel-(1R,3S,5S)-8-Methyl-8-azabicyclo[3,2,1]oct-6-en-yl-2-hydroxy-2,2-dithiophen-2-yl acetate | 136310-66-2 | C18H19NO3S2 |
|
rac3-脱乙酰基-3-丁酰基乙酰苯丁醇盐酸盐 | N-(3-Butyryl-4-(2-hydroxy-3-(isopropylamino)-propoxy)phenyl)butyramide hydrochloride | 57898-71-2 | C20H33ClN2O4 |
|
rac-反式-4-脱氟-4-甲氧基帕罗西汀盐酸盐 | rac-trans-4-Defluoro-4-methoxy Paroxetine Hydrochloride | 127017-74-7 | C20H24ClNO4 |
|
p-尼可地尔 | N-(2-nitroxyethyl)isonicotinamide | 65141-47-1 | C8H9N3O4 |
|
p-(2,3-环氧丙氧基)苄醇 | 2-{[4-(hydroxymethyl)phenoxy]methyl}oxirane | 4204-78-8 | C10H12O3 |
|
o-金刚烷基苯甲醚 | 1-(o-methoxyphenyl)adamantane | 43109-77-9 | C17H22O |
|
n-(4-甲基吡啶-3-基)氨基甲酸甲酯 | methyl (4-methylpyridin-3-yl)carbamate | 694495-63-1 | C8H10N2O2 |
|
ent-阿巴卡韦 | (+)-1592U89 | 136470-79-6 | C14H18N6O |
|
ent-恩曲他滨 | racivir | 137530-41-7 | C8H10FN3O3S |
|
ent-依折麦布 | ezetimibe | 1376614-99-1 | C24H21F2NO3 |
|
delta皮质素烯乙酸酯 | pregna-1,4,9(11)-triene-17α,21-diol-3,20-dione 21-acetate | 4380-55-6 | C23H28O5 |
|
delta2-头孢氨苄 | Δ<sup>2</sup>-cefalexin | 79750-46-2 | C16H17N3O4S |
|
delta2-头孢呋辛醋氧乙酯 | Δ-2-cefuroxime axetil | 123458-61-7 | C20H22N4O10S |
|
delta-3头孢克洛 | Delta-3-Cefaclor | 152575-13-8 | C15H14ClN3O4S |
|
delta-2-头孢地秦 | delta-2-Cefodizime | 120533-30-4 | C20H20N6O7S4 |
|
dUTP钠盐 | 94736-09-1 | C9H15N2NaO14P3 |
|
|
beta-雌二醇半水合物 | (8R,9S,13S,14S,17S)-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthrene-3,17-diol;hydrate | 35380-71-3 | C18H26O3 |
|
beta-羟基甲状腺素 | beta-Hydroxy thyroxine | 107849-54-7 | C15H11I4NO5 |
|
beta,beta-二甲基丙烯酰阿卡宁 | 11-O-(β,β-dimethylacryl)alkannin | 5162-01-6 | C21H22O6 |
|
alpha-西洋苦瓜素2-D-吡喃葡萄糖苷 | Colocynthin | 1398-78-3 | C38H54O13 |
|
alpha-羟基氟比洛芬 | 2-(2-fluorobiphen-4-yl)-2-hydroxypropionic acid | 61466-95-3 | C15H13FO3 |
|
alpha-羟基奥洛他定 | alpha-Hydroxyolopatadine | 1331822-32-2 | C21H23NO4 |
|
alpha-甲基-5-氧代-5H-[1]苯并吡喃并[2,3-b]吡啶-7-乙酸 | 2-(5-oxo-5<i>H</i>-chromeno[2,3-<i>b</i>]pyridin-7-yl)-propionic acid | 52549-19-6 | C15H11NO4 |
|
alpha-甲基-4-联苯乙酸 | 2-(4-biphenylyl)propanoic acid | 6341-72-6 | C15H14O2 |
|
alpha-甲基-4-(2-甲基丙基)-苯甲醇 | 1-(4-isobutylphenyl)ethanol | 40150-92-3 | C12H18O |
|
alpha-甲基-3-(4-甲基苯甲酰基)苯乙酸 | 2-[3-(4-methylbenzoyl)phenyl]propionic acid | 107257-20-5 | C17H16O3 |
|
alpha-地西他滨 | 4-Amino-1-[4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-1,3,5-triazin-2-one | 22432-95-7 | C8H12N4O4 |
|
alpha-乙基-2-氧代-1-吡咯烷乙酸 | α-ethyl-2-oxo-1-pyrrolidineacetic acid, | 67118-31-4 | C8H13NO3 |
|
alpha-[[[2-(4-甲氧基苯基)-1-甲基乙基](苯基甲基)氨基]甲基]-3-硝基-4-(苯基甲氧基)苯甲醇 | 1-(4-benzyloxy-3-nitrobenzene)-2-{benzyl-[2-(4-methoxyphenyl)-1-methylethyl]amino}ethanol | 43229-67-0 | C32H34N2O5 |
|