![图片[1]-202512-加拿大卫生部HC-Guidance on nitrosamineimpurities in medications药物中亚硝胺杂质的风险管控与合规要求-附下载-药研库](https://img.suyu.uk/i/2025/12/29/fd71dh.png)
2025 年 8 月 1 日,加拿大健康部(Health Canada)正式实施了更新后的《药物中亚硝胺杂质指南》,对人用药品、生物制品和放射性药品中的亚硝胺杂质风险评估、检测验证及市场授权变更等提出了全面要求。这一指南不仅明确了各类亚硝胺杂质的可接受摄入量(AI),更建立了从风险识别到风险 mitigation 的全流程管控框架,对制药企业、进口商及相关从业者具有重要指导意义。
一、核心管控范围:哪些产品需遵守新规?
此次指南的适用范围覆盖绝大多数人用药物,包括:
- 含化学合成或半合成活性药物成分(API)的处方药与非处方药,无论是否已上市或处于 “休眠” 状态;
- 所有生物制品和放射性药品,包括血浆蛋白、疫苗及细胞发酵产品;
- 含化学合成 API 的非处方外用产品(如消毒剂、防晒霜),不受给药途径或化妆品属性限制。
需注意的是,化妆品、兽药、天然保健品及硬质表面消毒剂暂不纳入管控范围。
二、时间节点
指南为不同类型产品设定了明确的合规 deadlines,企业需按以下步骤推进:
- 风险评估(第一步):化学合成 API 类药物需在 2021 年 3 月 31 日前完成,生物制品及放射性药品需在 2021 年 11 月 30 日前完成;
- 确认性检测(第二步):化学合成 API 类药物需在 2022 年 10 月 1 日前完成,生物制品及放射性药品需在 2023 年 11 月 30 日前完成;
- 市场授权变更(第三步):所有产品需在 2025 年 8 月 1 日前完成相关变更提交,针对已公布 AI 限值的杂质,企业可申请最长 3 年(至 2028 年 8 月 1 日)的纠正预防措施(CAPA)实施期。
三、核心技术要求:AI 限值与风险评估要点
1. 可接受摄入量(AI)限值分类
指南附录 1 明确了上百种亚硝胺杂质的 AI 限值,核心分类如下:
- 高致癌潜能类别(CPCA 1 类):AI 限值为 18 ng / 天,适用于具有强致癌性的亚硝胺(如 N - 亚硝基去甲基佐米曲坦);
- 中等致癌潜能类别(CPCA 2-3 类):AI 限值分别为 100 ng / 天和 400 ng / 天,涵盖常见杂质如 N - 亚硝基二甲胺(NDMA);
- 低致癌潜能类别(CPCA 4-5 类):AI 限值为 1500 ng / 天,适用于代谢活化风险较低的杂质;
- 特殊情形:非致突变性杂质需按 ICH Q3A/Q3B 指南管控,部分杂质(如双氯芬酸相关亚硝胺)AI 限值高达 78000 ng / 天。
2. 风险评估的核心要素
企业需采用整体风险评估方法,重点关注:
- 内在风险因素:API 结构中的仲胺 / 叔胺基团、亚硝化剂前体(如亚硝酸盐)的存在;
- 外在风险因素:生产过程中的酸性条件、容器密封系统中的亚硝化剂来源(如硝化纤维素);
- 全生命周期覆盖:从原料采购、生产工艺到储存条件的全链条风险识别。
四、企业合规操作指南
1. 检测与验证要求
- 检测方法需经过充分验证,定量限(LOQ)需≤AI 限值的 10%(常规检测)或 30%(周期性检测);
- 确认性检测需覆盖代表性批次,高风险产品(如含亚硝胺前体的 API)需检测 10% 年度批次或每年至少 3 批;
- 检测实验室需符合 GMP 要求,加拿大境外实验室需提供合规性证明。
2. 杂质控制策略
- 高风险 API 需在质量标准中加入亚硝胺单项限值及累积限值;
- 可采用多种控制方式:API 常规检测、上游中间体管控、工艺参数优化(如 pH 调节、添加抗氧化剂);
- 若检测到超标杂质(超过 AI 限值),需立即通知加拿大健康部,并启动召回、根因调查及 CAPA 计划。
3. 市场授权变更提交
- 风险 mitigation 相关变更需以补充申请、告知性变更或 DIN 后变更形式提交;
- 提交文件需包含根因调查总结、控制策略说明及验证数据;
- 非风险相关变更(如新增规格)需提供无新增风险的科学论证。
附件中涉及的药物以及相关亚硝胺杂质限度(详细见下载链接的原表格)
| 最近发布日期 (YYYY-MM-DD) | 相关药物物质 | N-亚硝胺(及缩写,如果可用) | CAS RN(如果可用) | CPCA 类别 | AI 限值 (ng/日)* |
|---|---|---|---|---|---|
| 2025-12-17 | Doravirine | N-nitroso-doravirine dimer | ― | _ | 1500*** |
| 2025-12-17 | Berotralstat | N-nitroso-berotralstat | ― | ― | 1500*** |
| 2025-12-17 | Relebactam | N-nitroso-relebactam | ― | 3 | 400 |
| 2025-12-17 | Olanzapine | N-nitroso-olanzapine | ― | 5 | 1500 |
| 2025-12-17 | Elagolix | N-nitroso-elagolix | ― | 4 | 1500 |
| 2025-12-17 | Zolmitriptan | N-nitroso-desmethyl-zolmitriptan | ― | 1 | 18 |
| 2025-12-17 | Diphenhydramine | N-nitroso-N-desmethyl-diphenhydramine | 55855-43-1 | ― | 100 |
| 2025-12-17 | Valacyclovir | N-nitroso-N-methyl-valacyclovir | ― | ― | 1500*** |
| 2025-12-17 | Perindopril | N-nitroso-perindopril | ― | ― | ** |
| 2025-12-17 | Ramipril | N-nitroso-ramipril | ― | ― | ** |
| 2025-12-17 | Quetiapine | 2-(2-(4-nitrosopiperazin-1-yl)ethoxy)ethan-1-ol | 73486-81-4 | 3 | 400 |
| 2025-12-17 | Pseudoephedrine | N-nitroso-pseudoephedrine | 1850-88-0 | ― | 1500*** |
| 2025-08-01 | Almotriptan | N-nitroso-desmethyl-almotriptan | _ | 1 | 18 |
| 2025-08-01 | Amiodarone | N-nitroso-N-desethyl-amiodarone | 678982-38-2 | 1 | 18 |
| 2025-08-01 | Cabergoline | N-nitroso-N-desmethyl-cabergoline | _ | 1 | 18 |
| 2025-08-01 | Diltiazem | N-nitroso-N-desmethyl-diltiazem | 3036581-85-5 | 1 | 18 |
| 2025-08-01 | Ropinirole | N-nitroso-N-despropyl-ropinirole | ― | 1 | 18 |
| 2025-08-01 | Cobicistat | N-((2- isopropylthiazol-4-yl) methyl)-N-methylnitrous amide (NNTA) | ― | 1 | 18 |
| 2025-08-01 | Brinzolamide | N-nitroso-brinzolamide | _ | 2 | 100 |
| 2025-08-01 | Carvedilol | N-nitroso-carvedilol | 2248746-67-8 | 3 | 400 |
| 2025-08-01 | Safinamide | N-nitroso-safinamide | 2657645-00-4 | 3 | 400 |
| 2025-08-01 | Methadone | N-nitroso-N-desmethyl-methadone | ― | 3 | 400 |
| 2025-08-01 | Dalbavancin | N-nitroso-dalbavancin | _ | 4 | 1500 |
| 2025-08-01 | Norfloxacin | N-nitroso-norfloxacin | 74011-53-3 | 4 | 1500 |
| 2025-08-01 | Vancomycin | N-nitroso-vancomycin | ― | 4 | 1500 |
| 2025-08-01 | Danicopan | (2S,4R)-N-(6-bromopyridin-2-yl)-4-fluoro-1-nitrosopyrrolidine-2-carboxamide | ― | 4 | 1500 |
| 2025-08-01 | Vanzacaftor | N-nitroso-vanzacaftor (^) | ― | 4 | 1500 |
| 2025-08-01 | Acarbose | N-nitroso-acarbose | _ | 5 | 1500 |
| 2025-08-01 | Nadolol | N-nitroso-nadolol | 134720-06-2 | 5 | 1500 |
| 2025-08-01 | Doxylamine | N-nitroso-N-desmethyl-doxylamine | ― | ― | 100 |
| 2024-12-11 | Ritonavir | N-((2-isopropylthiazol-4-yl) methyl)-N-methylnitrous amide(NNTA) | _ | 1 | 18 |
| 2024-12-11 | Galantamine | N-nitroso-N-desmethyl-galantamine | ― | 1 | 18 |
| 2024-12-11 | Amitriptyline | N-nitroso-nortriptyline (NNORT) | 55855-42-0 | 1 | 18 |
| 2024-12-11 | Nortriptyline | N-nitroso-nortriptyline (NNORT) | 55855-42-0 | 1 | 18 |
| 2024-12-11 | Valsartan | (S)-Methyl 2-(((2'-cyano-[1,1'-biphenyl]-4-yl)methyl)(nitroso) amino)-3-methylbutanoate | _ | 2 | 100 |
| 2024-12-11 | Colesevelam | N-nitroso-didecylamine | _ | 2 | 100 |
| 2024-12-11 | Epinephrine | N-nitroso-epinephrine | ― | 2 | 100 |
| 2024-12-11 | Propafenone | N-nitroso-propafenone | _ | 2 | 100 |
| 2024-12-11 | Buspirone | 2-(4-nitrosopiperazine-1-yl)-pyrimidine | 872826-80-7 | 3 | 400 |
| 2024-12-11 | Dasatinib | N-nitroso-N-deshydroxyethyl-dasatinib | _ | 3 | 400 |
| 2024-12-11 | Acebutolol | N-nitroso-acebutolol | _ | 4 | 1500 |
| 2024-12-11 | Ivacaftor | N-nitroso-ivacaftor | ― | 5 | 1500 |
| 2024-12-11 | Bupropion | N-nitroso-bupropion | 2763780-10-3 | ― | ** |
| 2024-12-11 | Diclofenac | N-nitroso-diclofenac | 66505-80-4 | ― | 78000 |
| 2024-07-26 | Rizatriptan | N-nitroso-N-desmethyl-rizatriptan | _ | 1 | 18 |
| 2024-07-26 | Tramadol | N-nitroso-N-desmethyl-tramadol | ― | 1 | 18 |
| 2024-07-26 | Riociguat | N-(4,6-diamino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)pyrimidin-5-yl)-N-methylnitrous amide | ― | 2 | 100 |
| 2024-07-26 | Sertraline | N-nitroso-sertraline | ― | 2 | 100 |
| 2024-07-26 | Benzydamine | 3-(dimethylamino)propyl 2-(benzyl(nitroso)amino)benzoate | ― | 3 | 400 |
| 2024-07-26 | Nintedanib | N-nitroso-N-desmethyl-nintedanib | _ | 3 | 400 |
| 2024-07-26 | Tetracaine | N-nitroso-tetracaine | _ | 3 | 400 |
| 2024-07-26 | Caspofungin | N-nitroso-caspofungin | ― | 4 | 1500 |
| 2024-07-26 | Esmolol | N-nitroso-esmolol | _ | 4 | 1500 |
| 2024-07-26 | Trandolapril | N-nitroso-trandolapril | ― | 5 | 1500 |
| 2024-07-26 | Ciprofloxacin | N-nitroso-ciprofloxacin | 864443-44-7 | ― | ** |
| 2024-07-26 | Entacapone | N-nitroso-diethylamine (NDEA) | 55-18-5 | ― | 26.5 |
| 2024-07-26 | Citalopram | N-nitroso-N-desmethyl-citalopram | ― | ― | 100 |
| 2024-05-31 | ― | 3-((ethyl(nitroso)amino)methyl)benzenesulfonate | ― | 1 | 18 |
| 2024-05-31 | Trientine | N-(2-aminoethyl)-N-(2-((2-aminoethyl)amino)ethyl)nitrous amide | ― | 1 | 18 |
| 2024-05-31 | ― | N-nitroso-N-ethyl-benzylamine (NBEA) | 20689-96-7 | 1 | 18 |
| 2024-05-31 | Sitagliptin | 7-nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro[1,2,4]triazolo-[4,3-a]pyrazine (NTTP) | 2892260-32-9 | 2 | 100 |
| 2024-05-31 | Edoxaban | N-nitroso-N-desmethyl-edoxaban | ― | 2 | 100 |
| 2024-05-31 | Mirabegron | (R)-N-(4-aminophenethyl)-N-(2-hydroxy-2-phenylethyl)nitrous amide | ― | 3 | 400 |
| 2024-05-31 | Posaconazole | 1-(4-(((3R,5R)-5-((1H-1,2,4-triazol-1-yl)methyl)-5-(2,4-difluorophenyl)tetrahydrofuran-3-yl)methoxy)phenyl)-4-nitrosopiperazine | ― | 3 | 400 |
| 2024-05-31 | Mirabegron | (R)-N-(2-hydroxy-2-phenylethyl)-N-(4-nitrophenethyl)nitrous amide | ― | 3 | 400 |
| 2024-05-31 | ― | N-nitroso-ethylisopropylamine (NEIPA) | 16339-04-1 | 3 | 400 |
| 2024-05-31 | Rivaroxaban | (R)-N-(3-chloro-2-hydroxypropyl)-N-(4-(3-oxomorpholino)phenyl)nitrous amide | ― | 4 | 1500 |
| 2024-05-31 | Rivaroxaban | (S)-2-(2-((4-(5-((5-chlorothiophene-2-carboxamido)methyl)-2-oxooxazolidin-3-yl)phenyl)(nitroso)amino)ethoxy)acetic acid | ― | 4 | 1500 |
| 2024-05-31 | Rivaroxaban | (S)-N-(3-(1,3-dioxoisoindolin-2-yl)-2-hydroxypropyl)-N-(4-(3-oxomorpholino)phenyl)nitrous amide | ― | 4 | 1500 |
| 2024-05-31 | Rivaroxaban | N-(2-hydroxyethyl)-N-phenylnitrous amide | 25413-76-7 | 4 | 1500 |
| 2024-05-31 | ― | N-nitroso-4-(methylamino)butyric acid (NMBA) | 61445-55-4 | 4 | 1500 |
| 2024-05-31 | Argatroban | N-nitroso-argatroban | ― | 4 | 1500 |
| 2024-05-31 | Articaine | N-nitroso-articaine | ― | 4 | 1500 |
| 2024-05-31 | ― | N-nitroso-diisopropylamine (NDIPA) | 601-77-4 | 5 | 1500 |
| 2024-05-31 | Lisinopril | N-nitroso-lisinopril | 519175-80-5 | ― | ** |
| 2024-05-31 | Clarithromycin | N-nitroso-N-desmethyl-clarithromycin | ― | ― | ** |
| 2024-05-31 | Tigecycline | N-nitroso-tigecycline | ― | ― | ** |
| 2024-03-28 | Clozapine | N-nitroso-clozapine EP Impurity C | ― | 3 | 400 |
| 2024-03-28 | Terazosin | N-nitroso-terazosin EP Impurity C | ― | 3 | 400 |
| 2024-03-28 | Apixaban | N-nitroso-apixaban Impurity B | ― | 4 | 1500 |
| 2024-03-28 | Methylphenidate | N-nitroso-ritalinic acid | ― | 4 | 1500 |
| 2024-03-28 | Silodosin | N-nitroso-silodosin | ― | 4 | 1500 |
| 2024-03-28 | Indapamide | (2RS)-2-methyl-1-nitroso-2,3-dihydro-1H-indole (Indapamide EP Impurity A) | 85440-79-5 | 5 | 1500 |
| 2024-03-28 | Gliclazide | 2-nitrosooctahydrocyclopenta[c]pyrrole (Gliclazide EP Impurity B) | 54786-86-6 | ― | 1700 |
| 2024-03-28 | ― | N-nitroso-meglumine | 62137-31-9 | ― | 1500*** |
| 2024-03-15 | Azelastine | N-nitroso-desmethylazelastine | ― | 2 | 100 |
| 2024-03-15 | Terazosin | (4-nitrosopiperazin-1-yl)(tetrahydrofuran-2-yl)methanone | ― | 3 | 400 |
| 2024-03-15 | Aripiprazole | 1-(2,3-dichlorophenyl)-4-nitrosopiperazine | 2221987-86-4 | 3 | 400 |
| 2024-03-15 | Bilastine | 1-(2-ethoxyethyl)-2-(1-nitrosopiperidin-4-yl)-1H-benzo[d]imidazole | ― | 3 | 400 |
| 2024-03-15 | Ranolazine | 1-(2-methoxyphenoxy)-3-(4-nitrosopiperazin-1-yl)propan-2-ol | ― | 3 | 400 |
| 2024-03-15 | Ranolazine | N-(2,6-dimethylphenyl)-2-(4-nitrosopiperazin-1-yl)acetamide | ― | 3 | 400 |
| 2024-03-15 | Tofacitinib | N-methyl-N-((3R,4R)-4-methyl-1-nitrosopiperidin-3-yl)-7H-pyrrolo[2,3-d]pyrimidin-4-amine | ― | 3 | 400 |
| 2024-03-15 | Landiolol | N-nitroso-landiolol | ― | 3 | 400 |
| 2024-03-15 | Mirtazapine | N-nitroso-N-desmethyl-mirtazepine | ― | 3 | 400 |
| 2024-03-15 | Sildenafil | N-nitroso-N-desmethyl-sildenafil | ― | 3 | 400 |
| 2024-03-15 | Benzydamine | 2-[benzyl(nitroso)amino]benzoic acid | 1028-91-7 | 4 | 1500 |
| 2024-03-15 | Betaxolol | N-nitroso-betaxolol | ― | 4 | 1500 |
| 2024-03-15 | Bumetanide | N-nitroso-bumetanide | 2490432-02-3 | 4 | 1500 |
| 2024-03-15 | Daridorexant | 5-chloro-4-methyl-2-[(2S)-2-methyl-1-nitrosopyrrolidin-2-yl]-1H-benzimidazole | ― | 5 | 1500 |
| 2024-03-15 | Dabigatran etexilate | N-nitroso-dabigatran etexilate | ― | ― | 1500*** |
| 2024-03-15 | Dorzolamide | N-nitroso-dorzolamide | ― | ― | 1500*** |
| 2024-03-15 | Leucovorin | N-nitroso-folinic acid | ― | ― | ** |
| 2023-10-20 | Alogliptin | 3-amino-N-nitrosopiperidine | 2819242-71-0 | 3 | 400 |
| 2023-10-20 | Cinacalcet | N-nitroso-cinacalcet | ― | 3 | 400 |
| 2023-10-20 | Rivaroxaban | (S)-5-chloro-N-(2-hydroxy-3-(nitroso(4-(3-oxomorpholino)phenyl)amino)propyl)thiophene-2-carboxamide | ― | 4 | 1500 |
| 2023-07-24 | Penicillin G benzathine | N,N'-dinitroso-N,N'-dibenzylethanediamine | ― | 1 | 18 |
| 2023-07-24 | Terbinafine | N-[(2E)-6,6-dimethyl-2-hepten-4-yn-1-yl]-N-nitrosomethanamine | ― | 1 | 18 |
| 2023-07-24 | Betahistine | N-nitroso-betahistine | 32635-81-7 | 1 | 18 |
| 2023-07-24 | Penicillin G benzathine | N-nitroso-N,N'-dibenzylethanediamine | ― | 1 | 18 |
| 2023-07-24 | Desvenlafaxine | N-nitroso-N-desmethyl-desvenlafaxine | ― | 1 | 18 |
| 2023-07-24 | Orphenadrine | N-nitroso-N-desmethyl-orphenadrine (NMOA) | ― | 1 | 18 |
| 2023-07-24 | Sumatriptan | N-nitroso-N-desmethyl-sumatriptan | ― | 1 | 18 |
| 2023-07-24 | Terbinafine | N-nitroso-N-desmethyl-terbinafine | ― | 1 | 18 |
| 2023-07-24 | Tripelennamine | N-nitroso-N-desmethyl-tripelennamine | ― | 1 | 18 |
| 2023-07-24 | Terbinafine | N-nitroso-N-methyl-1-naphthylmethylamine | 296760-88-8 | 1 | 18 |
| 2023-07-24 | Doxylamine | N-nitroso-N-methyl-2-[1-phenyl-1-(2-pyridinyl)methoxy]ethanamine | ― | 1 | 18 |
| 2023-07-24 | Doxepin | N-nitroso-nordoxepin | ― | 1 | 18 |
| 2023-07-24 | Lidocaine | N-nitroso-desethyl-lidocaine | ― | 2 | 100 |
| 2023-07-24 | Rivastigmine | N-nitroso-N-desmethyl-rivastigmine | ― | 2 | 100 |
| 2023-07-24 | Phenylephrine | N-nitroso-phenylephrine | 78658-64-7 | 2 | 100 |
| 2023-07-24 | Rasagiline | N-nitroso-rasagiline | 2470278-90-9 | 2 | 100 |
| 2023-07-24 | Rifapentine | 1-cyclopentyl-4-nitrosopiperazine (CPNP) | 61379-66-6 | 3 | 400 |
| 2023-07-24 | ― | 1-methyl-4-nitrosopiperazine (MNP) | 16339-07-4 | 3 | 400 |
| 2023-07-24 | Hydroxyzine | 2-(2-(4-nitrosopiperazin-1-yl)ethoxy)ethan-1-ol | 73486-81-4 | 3 | 400 |
| 2023-07-24 | Ciprofloxacin | N,N'-dinitrosopiperazine | 140-79-4 | 3 | 400 |
| 2023-07-24 | Quetiapine | N-nitroso-desalkyl-quetiapine (NDAQ) | ― | 3 | 400 |
| 2023-07-24 | Desloratadine | N-nitroso-desloratadine | 1246819-22-6 | 3 | 400 |
| 2023-07-24 | Frovatriptan | N-nitroso-frovatriptan | ― | 3 | 400 |
| 2023-07-24 | Mirabegron | N-nitroso-mirabegron | ― | 3 | 400 |
| 2023-07-24 | Doxycycline | N-nitroso-N-desmethyl-doxycycline | ― | 3 | 400 |
| 2023-07-24 | Valacyclovir | N-nitroso-N-ethyl-valacyclovir | ― | 3 | 400 |
| 2023-07-24 | ― | N-nitroso-piperazine | 5632-47-3 | 3 | 400 |
| 2023-07-24 | Pramipexole | N-nitroso-pramipexole | ― | 3 | 400 |
| 2023-07-24 | Varenicline | N-nitroso-varenicline (NNV) | 2755871-02-2 | 3 | 400 |
| 2023-07-24 | Vortioxetine | N-nitroso-vortioxetine | ― | 3 | 400 |
| 2023-07-24 | Levofloxacin | (S)-10-((2-aminoethyl)(nitroso)amino)-9-fluoro-3-methyl-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid | ― | 4 | 1500 |
| 2023-07-24 | Atenolol | N-nitroso-atenolol | 134720-04-0 | 4 | 1500 |
| 2023-07-24 | Bisoprolol | N-nitroso-bisoprolol | 2820170-76-9 | 4 | 1500 |
| 2023-07-24 | Flecainide | N-nitroso-flecainide | ― | 4 | 1500 |
| 2023-07-24 | Folic acid | N-nitroso-folic acid | 26360-21-4 | 4 | 1500 |
| 2023-07-24 | Furosemide | N-nitroso-furosemide | 2708280-93-5 | 4 | 1500 |
| 2023-07-24 | Labetalol | N-nitroso-labetalol | 2820170-74-7 | 4 | 1500 |
| 2023-07-24 | Meropenem | N-nitroso-meropenem | ― | 4 | 1500 |
| 2023-07-24 | Metoprolol | N-nitroso-metoprolol | 134720-05-1 | 4 | 1500 |
| 2023-07-24 | Moxifloxacin | N-nitroso-moxifloxacin | ― | 4 | 1500 |
| 2023-07-24 | Dextromethorphan | N-nitroso-N-desmethyl-dextromethorphan | ― | 4 | 1500 |
| 2023-07-24 | Levofloxacin | N-nitroso-N-desmethyl-levofloxacin | 1152314-62-9 | 4 | 1500 |
| 2023-07-24 | Nebivolol | N-nitroso-nebivolol | 1391051-68-5 | 4 | 1500 |
| 2023-07-24 | Propranolol | N-nitroso-propranolol | 84418-35-9 | 4 | 1500 |
| 2023-07-24 | Sotalol | N-nitroso-sotalol | 134720-07-3 | 4 | 1500 |
| 2023-07-24 | Tamsulosin | N-nitroso-tamsulosin | 2892260-31-8 | 4 | 1500 |
| 2023-07-24 | Benazepril | N-nitroso-benazepril | ― | 5 | 1500 |
| 2023-07-24 | Cilazapril | N-nitroso-cilazapril | 1053740-92-3 | 5 | 1500 |
| 2023-07-24 | Clozapine | N-nitroso-clozapine | 156632-03-0 | 5 | 1500 |
| 2023-07-24 | Enalapril | N-nitroso-enalapril | ― | 5 | 1500 |
| 2023-07-24 | Felodipine | N-nitroso-felodipine | ― | 5 | 1500 |
| 2023-07-24 | Ketamine | N-nitroso-ketamine | 86144-35-6 | 5 | 1500 |
| 2023-07-24 | Trimebutine | N-nitroso-N-desmethyl-trimebutine | ― | 5 | 1500 |
| 2023-07-24 | Salbutamol | N-nitroso-salbutamol | ― | 5 | 1500 |
| 2023-07-24 | Valsartan | (S)-2-(((2'-(1H-tetrazol-5-yl)-[1,1′-biphenyl]-4-yl)methyl)(nitroso)amino)-3-methylbutanoic acid | 2254485-68-0 | ― | ** |
| 2023-07-24 | Atomoxetine | N-nitroso-atomoxetine | ― | ― | 100 |
| 2023-07-24 | Azithromycin | N-nitroso-azaerythromycin | ― | ― | ** |
| 2023-07-24 | Fluoxetine | N-nitroso-fluoxetine | 150494-06-7 | ― | 100 |
| 2023-07-24 | Hydrochlorothiazide | N-nitroso-hydrochlorothiazide | 63779-86-2 | ― | ** |
| 2023-07-24 | Azithromycin | N-nitroso-N-desmethylazithromycin | ― | ― | ** |
| 2023-07-24 | ― | N-nitroso-pyrrolidine (NPYR) | 930-55-2 | ― | 1700 |
| 2023-07-24 | Quinapril | N-nitroso-quinapril | 158522-79-3 | ― | ** |
| 2023-04-17 | ― | N-nitroso-diethanolamine (NDELA) | 1116-54-7 | ― | 1900 |
| 2023-04-17 | ― | N-nitroso-diphenylamine (NDPh) | 86-30-6 | ― | 78000 |
| 2023-04-17 | Mefenamic acid | N-nitroso-mefenamic acid | 2114-63-8 | ― | 78000 |
| 2023-04-17 | Paroxetine | N-nitroso-paroxetine | 2361294-43-9 | ― | 1300 |
| 2022-09-01 | ― | 4-(methylnitrosoamino)-1-(3-pyridyl)-1-(butanone) (NNK) | 64091-91-4 | ― | 100 |
| 2022-05-27 | ― | N-methyl-N-nitroso-phenethylamine (NMPEA) | 13256-11-6 | ― | 8 |
| 2022-05-27 | ― | N-nitroso-1,2,3,6-tetrahydropyridine (NTHP) | 55556-92-8 | ― | 37 |
| 2022-05-27 | Duloxetine | N-nitroso-duloxetine (NDLX) | ― | ― | 100 |
| 2022-05-27 | Methylphenidate | N-nitroso-methylphenidate (NMPH) | 55557-03-4 | ― | 1300 |
| 2022-05-27 | ― | N-nitroso-piperidine (NPIP) | 100-75-4 | ― | 1300 |
| 2021-12-06 | ― | N-nitroso-dipropylamine (NDPA) | 621-64-7 | ― | 26.5 |
| 2021-12-06 | ― | N-nitroso-morpholine (NMOR) | 59-89-2 | ― | 127 |
| 2020-12-15 | ― | N-nitroso-dibutylamine (NDBA) | 924-16-3 | ― | 26.5 |
| 2019-10-02 | ― | N-nitroso-diethylamine (NDEA) | 55-18-5 | ― | 26.5 |
| 2019-10-02 | ― | N-nitroso-dimethylamine (NDMA) | 62-75-9 | ― | 96 |
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kidzhangy53天前0
感谢分享,楼主好人一生平安Terrific1月前0
感谢!特别有用,资源分享的很及时!北岛1年前0
相当于货架期多久?Mark3年前2
Thanks for your blog, nice to read. Do not stop.一位WordPress评论者4年前0
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