亚硝胺杂质对照品（NDMA 类）
热门品类2019 年以来，亚硝胺杂质重塑了全球药品检测。每一个易感原料药的放行批号都需要用认证对照品做 LC-MS/MS 或 GC-MS 检测——mg 级对照品的需求长期大于供给。我们按 FDA/TGA 可接受摄入量（AI）框架生产亚硝胺对照品及其同位素内标。
新增业务线 · 对照品
杂质对照品与亚硝胺对照品
mg 级高纯度药物杂质与亚硝胺对照品——由生产母体原料药的同一支合成团队制备。CoA 附 NMR、HPLC、MS 与卡尔费休水分数据。
mg scaleCoA: NMR · HPLC · MS · KF
与原料药同源：同一实验室，同一 GMP 纪律
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四大品类，全部自制，毫克级供应。可供应清单与报价经邮件提供。
药典杂质与有关物质对照品
热门品类USP/EP 各论为每种收载原料药列出命名有关物质（例如去氧肾上腺素杂质 1–7）。注册方必须分离并定量它们，实验室需要拿到这些化合物本身。我们的合成团队为自产的拟交感、抗组胺、中枢神经类原料药制备药典与非药典杂质对照品——随货 CoA（NMR、HPLC、MS、卡尔费休水分）。把您在做的各论杂质清单发给我们，我们确认可供应范围。
定制合成与工作标准品标定
目录外的杂质——强制降解产物、代谢物、贵方 CoA 上标记的未知工艺杂质——按定制合成项目（mg 级）报价。对厂内工作标准品，我们支持按 USP <11> 原则的赋值/确证资料包。
氘代 / 13C 内标
同位素标记类似物（如 d6-NDMA、13C2-NDMA）是 LC-MS/MS 亚硝胺方法定量的支柱——且长期稀缺。我们供应标记内标，CoA 附完整同位素丰度数据。
亚硝胺对照品目录（节选）
单异构体无偏置 N-亚硝胺，纯度赋值——每一个易感原料药如今都必须用它们来建立检测方法。
表中 AI（可接受摄入量）数值取自 FDA CDER 与 TGA 公开清单（2026 年 10 月核对），仅供参考；监管方会更新——请以现行官方清单为准。
按母体原料药查杂质对照品
原料药中文通用名重名严重（盐型、酯型一药多名），因此我们一律以 CAS 号识别化合物——这是唯一可靠的标准——并且每个杂质都注明所属母体原料药。下方按母体浏览；现货、规格与价格以邮件确认。
CAS 登记号为第一识别符；名称仅作导读。
盐酸去氧肾上腺素 Phenylephrine Hydrochloride
CAS 61-76-7- EP Impurity A(1R)-2-amino-1-(3-hydroxyphenyl)ethanol (norphenylephrine / norfenefrine)636-87-3
- EP Impurity C = USP Related Compound C1-(3-hydroxyphenyl)-2-(methylamino)ethanone (phenylephrone), hydrochloride94240-17-2
- EP Impurity D = USP Related Compound D(1R)-2-(benzylmethylamino)-1-(3-hydroxyphenyl)ethanol (benzylphenylephrine)1367567-95-0
- EP Impurity E = USP Related Compound E2-(benzylmethylamino)-1-(3-hydroxyphenyl)ethanone (benzylphenylephrone), hydrochloride71786-67-9
- EP Impurity A (salt form)3-(2-amino-1-hydroxyethyl)phenol hydrochloride (norphenylephrine hydrochloride)4779-94-6
- USP Related Compound F(R)-2-methyl-1,2,3,4-tetrahydroisoquinoline-4,8-diol (hydrochloride monohydrate)1007885-60-0
- USP Related Compound G(R)-N-(2-hydroxy-2-(3-hydroxyphenyl)ethyl)-N-methylglycine (phenylephrine carboxy analog)1094089-46-9
- USP degradant: 3-hydroxybenzaldehyde (非字母编号)3-hydroxybenzaldehyde100-83-4
- USP degradant: isoquinoline 4,6-diol analog (非字母编号)2-methyl-1,2,3,4-tetrahydroisoquinoline-4,6-diol23824-24-0
- USP degradant: isoquinolinone analog (非字母编号)1-(3-hydroxybenzoyl)-2-methylisoquinolin-6(2H)-oneCAS 待核实——以 CoA 为准
- N-Nitroso phenylephrine (亚硝胺杂质，非药典收载)N-[(2R)-2-hydroxy-2-(3-hydroxyphenyl)ethyl]-N-methyl-nitrous amide (N-nitrosophenylephrine)78658-64-7
重酒石酸去氧肾上腺素 Phenylephrine Bitartrate
CAS 17162-39-9- USP Related Compound C (same as Phenylephrine)1-(3-hydroxyphenyl)-2-(methylamino)ethan-1-one (phenylephrone)52093-42-2
- USP Related Compound D (same as Phenylephrine)(R)-3-{2-[benzyl(methyl)amino]-1-hydroxyethyl}phenol1367567-95-0
- USP Related Compound E (same as Phenylephrine)2-[benzyl(methyl)amino]-1-(3-hydroxyphenyl)ethan-1-one hydrochloride71786-67-9
- USP: Norphenylephrine (same as Phenylephrine EP Impurity A)3-(2-amino-1-hydroxyethyl)phenol hydrochloride4779-94-6
去氧肾上腺素（游离碱） Phenylephrine base
CAS 59-42-7- EP Impurity A (same as Phenylephrine HCl)(1R)-2-amino-1-(3-hydroxyphenyl)ethanol (norphenylephrine)636-87-3
- EP Impurity C (same as Phenylephrine HCl)1-(3-hydroxyphenyl)-2-(methylamino)ethanone (phenylephrone)52093-42-2
- EP Impurity D (same as Phenylephrine HCl)(1R)-2-(benzylmethylamino)-1-(3-hydroxyphenyl)ethanol (benzylphenylephrine)1367567-95-0
- EP Impurity E (same as Phenylephrine HCl)2-(benzylmethylamino)-1-(3-hydroxyphenyl)ethanone (benzylphenylephrone)56917-44-3
琥珀酸多西拉敏 Doxylamine succinate
CAS 562-10-7- EP Impurity CN,N-dimethyl-2-[(1RS)-1-phenyl-1-(pyridin-2-yl)methoxy]ethan-1-amine (N-desmethyldoxylamine)1442-21-3
- USP: 2-Benzoylpyridine = EP Impurity Dphenyl(pyridin-2-yl)methanone (2-benzoylpyridine)91-02-1
- USP: Carbinoxamine Related Compound C (= N-desmethyldoxylamine) = EP Impurity CN,N-dimethyl-2-[phenyl(pyridin-2-yl)methoxy]ethan-1-amine (desmethyl doxylamine)1221-70-1
- USP: Doxylamine alcohol = EP Impurity B1-phenyl-1-(pyridin-2-yl)ethan-1-ol (α-methyl-α-phenyl-2-pyridinemethanol)19490-92-7
- USP: Doxylamine dioxide (N,N'-dioxide)N,N-dimethyl-2-(1-(1-oxidopyridin-2-yl)-1-phenylethoxy)ethan-1-amine oxide105176-70-3
- USP: Doxylamine ethylamine N-oxideN,N-dimethyl-2-[1-phenyl-1-(pyridin-2-yl)ethoxy]ethan-1-amine oxide97143-65-2
- USP: Doxylamine pyridine-4-yl isomer = EP Impurity AN,N-dimethyl-2-[1-phenyl-1-(pyridin-4-yl)ethoxy]ethan-1-amine873407-01-3
- USP: Doxylamine pyridinyl N-oxide2-[1-(2-(dimethylamino)ethoxy)-1-phenylethyl]pyridine 1-oxide99430-77-0
- N-Nitroso N,C-didesmethyl doxylamine（亚硝胺，非药典）N-nitroso-N,C-didesmethyl doxylamineCAS 待核实——以 CoA 为准
- N-Nitroso N-desmethyl doxylamine（亚硝胺，非药典）N-nitroso-N-desmethyl doxylamineCAS 待核实——以 CoA 为准
盐酸依替福林 Etilefrine HCL
CAS 943-17-9- EP/BP Impurity A2-(ethylamino)-1-(3-hydroxyphenyl)ethanone (etilefrone)22510-04-9
- EP/BP Impurity B(1RS)-1-(3-hydroxyphenyl)-2-(methylamino)ethanol (phenylephrine, racemic)1477-63-0
- EP/BP Impurity C(1RS)-2-amino-1-(3-hydroxyphenyl)ethanol (norfenefrine / norphenylephrine)4779-94-6
- EP/BP Impurity D2-(benzylethylamino)-1-(3-hydroxyphenyl)ethanone (benzyletilefrone)42146-10-1
- EP/BP Impurity E1-(3-hydroxyphenyl)ethanone (3-hydroxyacetophenone)121-71-1
- EP/BP Impurity F (other detectable)N-benzylethanamine (benzylethylamine)14321-27-8
- N-Nitroso etilefrine（亚硝胺，非药典）N-nitroso etilefrine78658-62-5
重酒石酸去甲肾上腺素 Norepinephrine Bitartrate
CAS 108341-18-0- EP Impurity A (other detectable)adrenaline (epinephrine)51-43-4
- EP Impurity C (other detectable)dopamineCAS 待核实——以 CoA 为准
- EP Impurity D4-[(1R)-2-amino-1-methoxyethyl]benzene-1,2-diol (noradrenaline methyl ether)CAS 待核实——以 CoA 为准
- EP Impurity E2-chloro-1-(3,4-dihydroxyphenyl)ethanone (α-chloro-3,4-dihydroxyacetophenone)99-40-1
- EP Impurity FN-benzyl-1-phenylmethanamine (dibenzylamine)CAS 待核实——以 CoA 为准
- EP Impurity G (other detectable)2-(dibenzylamino)-1-(3,4-dihydroxyphenyl)ethanoneCAS 待核实——以 CoA 为准
- USP: Arterenone (limit test) ≡ EP Impurity B2-amino-1-(3,4-dihydroxyphenyl)ethanone (noradrenalone / arterenone)499-61-6
肾上腺素 Epinephrine (Adrenaline)
CAS 51-43-4- EP/BP Impurity B4-[(1R)-2-amino-1-hydroxyethyl]benzene-1,2-diol (noradrenaline)51-41-2
- EP/BP Impurity C = USP Adrenalone1-(3,4-dihydroxyphenyl)-2-(methylamino)ethan-1-one (adrenalone)62-13-5
- EP/BP Impurity D = USP N-Benzyl Epinephrine4-[(1R)-2-[benzyl(methyl)amino]-1-hydroxyethyl]benzene-1,2-diol (N-benzyl epinephrine)1095714-91-2
- EP/BP Impurity E = USP N-Benzyl Adrenalone2-[benzyl(methyl)amino]-1-(3,4-dihydroxyphenyl)ethan-1-one (N-benzyl adrenalone)36467-25-1
- EP/BP Impurity F = USP Epinephrine sulfonate(1R)-1-(3,4-dihydroxyphenyl)-2-(methylamino)ethane-1-sulfonic acid26405-77-6
- USP: (S)-Epinephrine (enantiomeric purity)(S)-epinephrine (dexamethasone-side enantiomer)150-05-0
- USP: Epinephrine methoxy analogmethoxy adrenaline (O-methyl epinephrine) hydrochloride74571-90-7
- USP: Epininedeoxyepinephrine (epinine; 4-(2-(methylamino)ethyl)phenol) hydrochloride62-32-8
- USP: Oxedrine (deoxyepinephrine)4-[1-hydroxy-2-(methylamino)ethyl]phenol (oxedrine / deoxyepinephrine)94-07-5
- N-Nitroso epinephrine（亚硝胺，非药典）N-nitroso epinephrine3038740-97-2
- Adrenochrome（氧化降解，非药典指定）adrenochrome (3-hydroxy-1-methyl-2,3-dihydro-1H-indole-5,6-dione)54-06-8
- USP: 4-chlorocatechol4-chlorobenzene-1,2-diol (4-chlorocatechol)2138-22-9
酒石酸肾上腺素 Epinephrine Bitartrate
CAS 51-42-3- EP Adrenaline Tartrate Impurity B–F (same as Adrenaline)noradrenaline / adrenalone / N-benzyl adrenaline / N-benzyl adrenalone / adrenaline sulfonic acidCAS 待核实——以 CoA 为准
- USP: Adrenalone1-(3,4-dihydroxyphenyl)-2-(methylamino)ethan-1-one (adrenalone) hydrochloride62-13-5
- USP: Norepinephrine(R)-4-(2-amino-1-hydroxyethyl)benzene-1,2-diol (norepinephrine)51-41-2
- USP: Unidentified impurity 1unidentified impurity peak 1CAS 待核实——以 CoA 为准
盐酸异丙肾上腺素 Isoproterenol HCL
CAS 51-30-9- USP Related Compound A (= isoproterenone) ≡ EP Impurity A (= isoproterenone HCl)1-(3,4-dihydroxyphenyl)-2-[(1-methylethyl)amino]ethanone (isoproterenone), hydrochloride16899-81-3
硫酸异丙肾上腺素 Isoproterenol Sulfate
CAS 299-95-6- EP Impurity A (same as Isoproterenol HCl)1-(3,4-dihydroxyphenyl)-2-[(1-methylethyl)amino]ethanone (isoproterenone)16899-81-3
- USP: Metaproterenol / orciprenaline（相关物质对照）metaproterenol (orciprenaline; 5-[1-hydroxy-2-(isopropylamino)ethyl]benzene-1,3-diol) sulfateCAS 待核实——以 CoA 为准
酒石酸辛弗林 Synephrine Tartrate
CAS 16589-24-5- 相关胺类杂质 · octopamine（非药典收载）octopamine (norsynephrine)770-05-8
- 相关胺类杂质 · phenylephrine（非药典收载）phenylephrine59-42-7
- 相关胺类杂质 · tyramine（非药典收载）tyramineCAS 待核实——以 CoA 为准
盐酸辛弗林 Synephrine HCL
CAS 5985-28-4- 对映体（消旋化）风险项synephrine enantiomers ((R)/(S))CAS 待核实——以 CoA 为准
- 相关胺类杂质 · octopamine（非药典收载）octopamine (±)-4-(2-amino-1-hydroxyethyl)phenol770-05-8
- 相关胺类杂质 · phenylephrine（非药典收载）phenylephrine / phenylephrine hydrochloride61-76-7
盐酸多佐胺 Dorzolamide HCL
CAS 130693-82-2- EP Impurity B 异构体 (4S,6R)(4S,6R)-4-(ethylamino)-6-methyl-5,6-dihydro-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide139066-77-6
- EP Impurity B, 单一非对映体 (4R,6S)(4R,6S)-4-(ethylamino)-6-methyl-5,6-dihydro-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide149249-72-9
- EP Impurity Cdorzolamide cyclic boronate ester adduct (C10H17BN2O6S3)CAS 待核实——以 CoA 为准
- USP Related Compound A = EP Impurity A (hydrochloride)(4R,6R)-4-(ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2-sulfonamide-7,7-dioxide monohydrochloride (ent-dorzolamide HCl)122028-36-8
- USP Related Compound B = EP Impurity B (hydrochloride)(4RS,6SR)-4-(ethylamino)-6-methyl-5,6-dihydro-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide hydrochloride120279-37-0
- USP Related Compound D = EP Impurity D (hydrochloride)(4S,6S)-4-amino-6-methyl-5,6-dihydro-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide hydrochloride (N-deethyldorzolamide HCl)164455-27-0
- Dorzolamide 其他非药典相关物dorzolamide maleic ester ((n-1) adduct), C14H20N2O8S3 dimer (CAS 3127911-34-3)3127911-34-3
为什么「制造商自制对照品」值得选
正因为母体原料药（去氧肾上腺素、肾上腺素、异丙肾上腺素、多西拉敏等）就是我们自己生产的——我们掌握它们的合成知识、基准批次与降解谱。这种垂直整合，就是我们的杂质对照品与您实际检材同源可比的原因。
把您各论或 CoA 上的杂质清单发给我们。
我们一封信回复：可供品类、纯度、规格与交期。