N-亚硝基马立巴韦 新品

N - 亚硝基马立巴韦（产品编号：M076013）

1. 产品信息

• 产品编号：M076013

• 英文名：N-Nitroso Maribavir

• 英文别名：N-(5,6-dichloro-1-((2S,3S,4R,5S)-3,4-dihydroxy-5-(hydroxymethyl) tetrahydrofuran-2-yl)-1H-benzo [d] imidazol-2-yl)-N-isopropylnitrous amide

• CAS 号：N/A

• 分子式：C15H18Cl2N4O5

• 分子量：405.23

2. 优势

1. 结构与马立巴韦母核完全匹配，为专属 N - 亚硝基基因毒性杂质对照品；

2. 纯度≥98%，理化性质稳定，适配痕量杂质定量检测；

3. 适配 LC-MS/MS、UPLC-UV 等主流分析手段，适配药品申报全套方法验证。

3. 应用

1. 马立巴韦原料药及制剂中亚硝胺杂质日常质量监控；

2. 建立并验证高灵敏度亚硝胺检测分析方法；

3. 追溯合成、储存环节杂质生成诱因，优化生产纯化工艺。

4. 背景描述

5. 研究现状

1. 该杂质归为药物相关亚硝胺杂质（NDSRI），遵循 ICH M7 基因毒性杂质管控指南；

2. 行业统一采用 LC-MS/MS 实现 ppb 级痕量定性定量；

3. 现有工艺优化方向：规避亚硝酸盐原料、调控体系 pH、增设精制步骤抑制杂质生成。

N-Nitroso Maribavir (Product Code: M076013)

1. Product Information

• Product Code: M076013

• English Name: N-Nitroso Maribavir

• English Aliases: N-(5,6-dichloro-1-((2S,3S,4R,5S)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)-1H-benzo[d]imidazol-2-yl)-N-isopropylnitrous amide

• CAS No.: N/A

• Molecular Formula: C15H18Cl2N4O5

• Molecular Weight: 405.23

2. Advantages

1. Fully consistent core skeleton with Maribavir, serving as exclusive reference standard for genotoxic N-nitroso impurity;

2. Purity ≥ 98% with stable physicochemical properties, suitable for quantitative trace analysis;

3. Compatible with mainstream analytical instruments including LC-MS/MS and UPLC-UV, supporting full method validation for pharmaceutical registration.

3. Applications

1. Routine quality control of nitrosamine impurities in Maribavir API and finished formulations;

2. Establishment and validation of high-sensitivity analytical methods for nitrosamine detection;

3. Trace the root cause of impurity formation during synthesis and storage, optimize manufacturing and purification processes.

4. Background Description

5. Research Status

1. Classified as Drug-Related N-Nitroso Impurity (NDSRI), complying with ICH M7 guideline for genotoxic impurities control;

2. LC-MS/MS is universally adopted to realize ppb-level qualitative and quantitative detection;

3. Current process optimization focuses on eliminating nitrite-containing raw materials, adjusting system pH and adding purification procedures to restrain impurity formation.