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 |
|---|---|---|---|---|
| 美托洛尔杂质18(单体) | (-)-Metoprolol hydrochloride | 114218-35-8 | C15H25NO3*ClH |
|
| 美托咪定标准品003 | 5-(chloroethyl)-2-methyltoluene | 104245-83-2 | C10H13Cl |
|
| 罗氟司特-imK | roflumilast N-oxide | 292135-78-5 | C17H14Cl2F2N2O4 |
|
| 罗格列酮相关物质A | (Z)-5-[4-[2-[N-methyl-N-(pyridin-2-yl)amino]ethoxy]benzylidene]thiazolidine-2,4-dione | 160596-25-8 | C18H17N3O3S |
|
| 罗库溴铵起始原料A杂质Ⅵ-B | 10,13-Dimethyl-2,16-dipyrrolidin-1-yl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthrene-3,17-diol | 144209-33-6 | C27H46N2O2 |
|
| 罗库溴铵杂质30 | 2,4-Androstadien-17-on | 56240-11-0 | C19H26O |
|
| 罗库溴铵杂质3 | androst-2-ene-17-one | 14639-79-3 | C19H28O |
|
| 罗库溴铵杂质3 | Androst-2-en-17-on | 963-75-7 | C19H28O |
|
| 罗库溴铵杂质 | 3-hydroxy-2,16-di-morpholin-4-yl-androstan-17-one | 13492-57-4 | C27H44N2O4 |
|
| 罗库溴胺杂质H | 1,2-Dehydro-3-oxo Rocuronium Bromide | 1190105-67-9 | C32H49BrN2O4 |
|
| 罗哌卡因标准品004 | N-(2,4-dimethylphenyl)picolinamide | 352637-51-5 | C14H14N2O |
|
| 罗哌卡因标准品0-R | (+)-Ropivacaine | 98717-16-9 | C17H26N2O |
|
| 罗哌卡因杂质D | (S)-1-ethyl-2',6'-pipecoloxylidide | 98626-59-6 | C16H24N2O |
|
| 罗哌卡因杂质 | roivacaine | 1050482-18-2 | C17H26N2O |
|
| 罗哌卡因杂质 | cyclo-(D-Pip-L-Pip) | 36585-31-6 | C12H18N2O2 |
|
| 罗哌卡因杂质 | roivacaine | 265120-58-9 | C17H26N2O |
|
| 罗哌卡因杂质 | Nicotinsaeure-(2,6-dimethyl-anilid) | 84951-65-5 | C14H14N2O |
|
| 罗哌卡因杂质 | 1-ethyl-piperidine-2-carboxylic acid-(2,6-dimethyl-anilide) | 2180-94-1 | C16H24N2O |
|
| 缬沙坦杂质12 | methyl pentanoyl-L-valinate | 1189547-11-2 | C11H21NO3 |
|
| 缬沙坦-d9（主要） | Valsartan D9 | 1089736-73-1 | C24H29N5O3 |
|
| 缩宫素杂质10 | N-Acetyloxytocin | 10551-48-1 | C45H68N12O13S2 |
|
| 维达洛芬 | 2-(4-cyclohexyl-1-naphthyl)propionic acid | 71109-09-6 | C19H22O2 |
|
| 维甲素EP杂质F | 4-(4-amino-hex-5-enoylamino)-hex-5-enoic acid | 794466-81-2 | C12H20N2O3 |
|
| 维生素K1杂质1 | vitamin K<sub>1</sub> chromenol | 19274-66-9 | C31H46O2 |
|
| 维生素B6杂质57 | N-(4-Desoxy-pyridoxolyl)-pyridoxolbetain | 18436-47-0 | C16H19N2O5*H |
|
| 维生素B1杂质7 | O-Acetyl-thiamin | 3419-28-1 | C14H19N4O2S*Cl |
|
| 维生素B1杂质5 | Thiothiamine hydrochloride | 2443-50-7 | C12H17ClN4OS2 |
|
| 维生素B1杂质3 | beclotiamine | 13471-78-8 | C12H16ClN4S*Cl |
|
| 维格列汀杂质A | (S)-1-glycylpyrrolidine-2-carbonitrile | 914070-99-8 | C7H11N3O |
|
| 维格列汀杂质57 | (S)-1-(2-aminoacetyl)pyrrolidine-2-carbonitrile hydrochloride | 913980-23-1 | C7H11N3O*ClH |
|
| 维格列汀杂质30 | 6-aminoadamantane-1,3-diol | 918830-94-1 | C10H17NO2 |
|
| 维格列汀杂质 | (5aS,10aS)-octahydrodipyrrolo[1,2-a:1',2'-d]pyrazine-5,10-dione | 19943-27-2 | C10H14N2O2 |
|
| 维格列汀-12 | (3-hydroxyadamantan-1-ylamino)acetic acid | 1032564-18-3 | C12H19NO3 |
|
| 维格列汀-06 | 1-chloroacetyl-2-cyano-(R)-pyrrolidine | 565452-98-4 | C7H9ClN2O |
|
| 维拉帕米杂质O | Desisopropyl N-propyl verapamil | 959011-16-6 | C27H38N2O4 |
|
| 维拉帕米杂质N(EP) | 5,5'-(Methylimino)bis(2-(3,4-dimethoxyphenyl)-2-(1-methylethyl)pentanenitrile) | 2086274-75-9 | C33H47N3O4 |
|
| 维库溴铵杂质 | DES(1-methylpiperidinium)-17-oxo vecuronium | 18668-29-6 | C26H41NO3 |
|
| 维加巴特林杂质E | 2-(2-aminobut-3-enyl)malonic acid | 1378466-25-1 | C7H11NO4 |
|
| 纽莫康定C(0) | Pneumocandin C(0) | 144074-96-4 | C50H80N8O17 |
|
| 纽莫康定(肺囊康定)A0 | Pubchem_53486263 | 539823-80-8 | C56H71N9O19 |
|
| 纳美芬杂质 | 2,2'-Bisnalmefene | 176220-84-1 | C42H48N2O6 |
|
| 纳拉曲坦杂质E | 1-(2-(N-Methylsulfamoyl)ethyl) naratriptan | 1346746-73-3 | C20H32N4O4S2 |
|
| 红霉素杂质E(EP) | EM 201 | 857839-61-3 | C37H65NO12 |
|
| 红霉素C | erythromycin C | 1675-02-1 | C36H65NO13 |
|
| 红霉素B | erythromycin B | 527-75-3 | C37H67NO12 |
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| 红霉素A氧化物 | erythromycin A N-oxide | 992-65-4 | C37H67NO14 |
|
| 红霉糖胺 | erythralosamine | 546-57-6 | C29H49NO8 |
|
| 红镰霉素-6-O-β-龙胆二糖苷 | rubrofusarin 6‐O‐β‐gentiobioside | 24577-90-0 | C27H32O15 |
|
| 紫杉醇侧链杂质 | methyl (2R,3R)-phenylisoserine | 157722-44-6 | C10H13NO3 |
|
| 紫杉醇EP杂质O | N-debenzoyl-N-cinnamoylpaclitaxel | 219783-77-4 | C49H53NO14 |
|
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