Characterization of a non-stoichiometric hydrate (active) in low dose capsules with ssNMR

Webinar - 2024

利用固体核磁（ssNMR）技术分析低剂量胶囊中的非化学计量水合物（活性）的特征

研讨会简介

固体核磁共振（ssNMR）是一种功能强大、灵敏度高的分析工具，可在不受辅料干扰的情况下直接对药物产品中的活性药物成分进行表征。这项工作的重点是利用 19F ssNMR 和其他表征技术，确定 1% 含药量胶囊制剂中非化学计量水合物的水合状态。

由于晶格水含量随外部相对湿度变化而变化，可能会导致物理化学和含量一致性问题，因此确定制剂中存在的非化学计量水合物（NSH）中的水含量极为重要。利用在 0-100% 相对湿度范围内观察到的化学位移变化，19F ssNMR 可以成功确定药物产品中 NSH 的晶格水含量（0-0.85 摩尔）。

举办时间：

2024 年 3 月 5 日，北京时间晚上24:00

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研讨会亮点

低剂量制剂中非化学计量水合物的表征

1% 含药胶囊中活性物质水合状态的固体核磁共振分析

19F ssNMR 中的化学位移变化与晶格水含量随相对湿度变化的相关性

具体内容

本次网络研讨会重点介绍利用化学位移随相对湿度变化的函数关系，固体核磁可以成功确定 0-100% 相对湿度范围内药物含量极低（1%）的胶囊中非化学计量水合物的水合状态。

主讲人简介

Jonathan Hau，Genentech 高级科学研究员

Jonathan 在 Genentech 公司的合成分子制药组工作了 15 年，目前在固态化学组工作。他在结晶和无定形原料药以及复杂成品药的分析方面拥有丰富的经验。

Martial Piotto博士，布鲁克生物制品解决方案的医药产品经理

Martial Piotto 在美国普渡大学获得核磁共振波谱学博士学位（师从Pr. D. Gorenstein）。随后，他加入布鲁克（法国），担任核磁共振应用主管，负责核磁共振的各个领域，特别是开发新的脉冲序列和HRMAS技术。多年来，他对 NMR 在制药和医疗领域的应用越来越感兴趣。他目前的工作重点是通过结合核磁共振和多变量统计工具对生物制品（mAb和疫苗）进行表征。

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