CN Patent

CN115850266A — 瑞美吉泮新晶型及其制备方法

Assigned to Yangzhou Aoruite Pharmaceutical Co ltd · Expires 2023-03-28 · 3y expired

What this patent protects

本发明公开了瑞美吉泮新晶型及其制备方法。本发明的瑞美吉泮晶型APTI‑II,使用Cu‑Kα辐射,以2θ角度表示的X射线粉末衍射图谱在以下位置具有特征峰:5.2±0.2°、12.5±0.2°、14.8±0.2°、15.5±0.2°、15.6±0.2°、17.9±0.2°、20.5±0.2°、21.3±0.2°和25.9±0.2°。本发明的晶型APTI‑II和APTI‑III,经过简单操作即可高收率的转化为药用晶型。本发明通过晶型转化和晶型纯化,可以很好的提纯瑞美吉泮,也可对反应体系(HPLC纯度68.4%)通过一次析晶,使其纯度达到93.8%,二次纯化使瑞…

USPTO Abstract

本发明公开了瑞美吉泮新晶型及其制备方法。本发明的瑞美吉泮晶型APTI‑II,使用Cu‑Kα辐射,以2θ角度表示的X射线粉末衍射图谱在以下位置具有特征峰:5.2±0.2°、12.5±0.2°、14.8±0.2°、15.5±0.2°、15.6±0.2°、17.9±0.2°、20.5±0.2°、21.3±0.2°和25.9±0.2°。本发明的晶型APTI‑II和APTI‑III,经过简单操作即可高收率的转化为药用晶型。本发明通过晶型转化和晶型纯化,可以很好的提纯瑞美吉泮,也可对反应体系(HPLC纯度68.4%)通过一次析晶,使其纯度达到93.8%,二次纯化使瑞美吉泮HPLC纯度达到99.70以上,未知单杂小于0.10%,符合ICH对原料药的杂质要求。

Drugs covered by this patent

Patent Metadata

Patent number
CN115850266A
Jurisdiction
CN
Classification
Expires
2023-03-28
Drug substance claim
No
Drug product claim
No
Assignee
Yangzhou Aoruite Pharmaceutical Co ltd
Source
FDA Orange Book + USPTO grounding via Google Patents

Bibliographic data sourced from FDA Orange Book + USPTO public records. Plain-English summary generated by AI grounded in source text. Patent term extensions (PTR, SPC, pediatric) may shift the effective expiry. Not legal advice.

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