Characterization of Mannitol Polymorphic Forms in Lyophilized Protein Formulations Using a Multivariate Curve Resolution (MCR)-Based Raman Spectroscopic Method

Yong Xie; Wenjin Cao; Sampathkumar Krishnan; Hong Lin; Nina Cauchon

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Characterization of Mannitol Polymorphic Forms in Lyophilized Protein Formulations Using a Multivariate Curve Resolution (MCR)-Based Raman Spectroscopic Method

机译：使用基于多元曲线分辨率（MCR）的拉曼光谱法表征冻干蛋白质制剂中甘露醇多态形式

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摘要

To develop a novel multivariate curve resolution (MCR)-based Raman spectroscopic method to characterize and quantify five known mannitol solid-state forms in lyophilized protein formulations.

机译：要开发一种新颖的基于多变量曲线分辨率（MCR）的拉曼光谱方法，以表征和量化冻干蛋白制剂中五种已知的甘露醇固态形式。

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来源
《Pharmaceutical Research》 |2008年第10期|2292-2301|共10页
作者
Yong Xie; Wenjin Cao; Sampathkumar Krishnan; Hong Lin; Nina Cauchon;
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作者单位

Pharmaceutics Department Amgen Inc. One Amgen Center Dr. Thousand Oaks California 91320 USA;

Pharmaceutics Department Amgen Inc. One Amgen Center Dr. Thousand Oaks California 91320 USA;

Pharmaceutics Department Amgen Inc. One Amgen Center Dr. Thousand Oaks California 91320 USA;

Pharmaceutics Department Amgen Inc. One Amgen Center Dr. Thousand Oaks California 91320 USA;

Pharmaceutics Department Amgen Inc. One Amgen Center Dr. Thousand Oaks California 91320 USA;

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原文格式 PDF
正文语种 eng
中图分类
关键词
lyophilized protein products; mannitol; polymorphism; quantitation; Raman spectroscopy;

机译：冻干蛋白产物;甘露醇;多态性;定量;拉曼光谱;

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专利

1. Characterization of mannitol polymorphic forms in lyophilized protein formulations using a multivariate curve resolution (MCR)-based Raman spectroscopic method. [J] . Xie Y, Cao W, Krishnan Pharmaceutical research . 2008,第10期

机译：利用多元曲线分辨率（MCR）的拉曼光谱法，表征甘露醇多晶型形态学中的冻干蛋白配方。
2. Characterization of mannitol polymorphic forms in lyophilized protein formulations using a multivariate curve resolution (MCR)-based Raman spectroscopic method. [J] . Xie Y, Cao W, Krishnan Pharmaceutical research . 2008,第10期

机译：利用多元曲线分辨率（MCR）的拉曼光谱法，表征甘露醇多晶型形态学中的冻干蛋白配方。
3. Characterization of mannitol polymorphic forms in lyophilized protein formulations using a multivariate curve resolution (MCR)-based Raman spectroscopic method. [J] . Xie Y, Cao W, Krishnan Pharmaceutical research . 2008,第10期

机译：利用多元曲线分辨率（MCR）的拉曼光谱法，表征甘露醇多晶型形态学中的冻干蛋白配方。
4. Possibilities for decomposing Raman spectra of amino acids mixture by Multivariate Curve Resolution (MCR) analysis [C] . Irina A.Matveeva, Oleg O.Myakinin, Yulia A.Khristoforova, International Conference on Terahertz and Microwave Radiation: Generation, Detection, and Applications . 2020

机译：通过多变量曲线分辨率（MCR）分析分解氨基酸混合物的拉曼光谱的可能性
5. Characterization of protein structure in the solid state by H/D exchange with mass spectrometry and its application in lyophilized protein formulation [D] . Li, Yunsong 2007

机译：通过质谱进行H / D交换表征固态蛋白质结构及其在冻干蛋白质制剂中的应用
6. Simultaneous Determination of Drugs Affecting Central Nervous System (CNS) in Bulk and Pharmaceutical Formulations Using Multivariate Curve Resolution-Alternating Least Squares (MCR-ALS) [O] . Heba Shaaban, Ahmed Mostafa, Bushra Al-Zahrani, 2020

机译：使用多元曲线分辨率交替最小二乘（MCR-ALS）同时测定散装和药物制剂中影响中枢神经系统（CNS）的药物
7. Review for "Extraction of information about structural changes in a semisolid pharmaceutical formulation from near‐infrared and Raman images by multivariate curve resolution–alternating least squares and ComDim" [O] . 2020

机译：通过多变量曲线分辨率 - 交替的最小二乘和Comdim，“从近红外和拉曼图像从近红外和拉曼图像提取关于半固体药物制剂的结构变化的结构变化的信息。
8. Characterization of Lithium Electrode Surface in Lithium Secondary Batteries byIn situ Raman Spectroscopic Methods [R] . Tachikawa, H. 1993

机译：用原位拉曼光谱法表征锂二次电池中锂电极表面

Characterization of Mannitol Polymorphic Forms in Lyophilized Protein Formulations Using a Multivariate Curve Resolution (MCR)-Based Raman Spectroscopic Method

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