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  1. Elemental Impurities Studies_Analytical Development and Quality Study_CMC Study_Service_Bostal Drug Delivery Co., Ltd. EN
    2. EN 中文
Elemental Impurities Studies_Analytical Development and Quality Study_CMC Study_Service_Bostal Drug Delivery Co., Ltd.

Service

Service

CMC Study Manufacture Preclinical Study Clinical Study Drugs Registration

Elemental Impurities Studies


The laboratory is equipped with Inductively Coupled Plasma Mass Spectrometry (ICP-MS). We can provide elemental impurities study service, including:

◆The strategy of assessment and control of elemental impurities：Assess the elemental impurities in pyroducts according to ICH Q3D and national pharmacopoeia, and provide corresponding control strategies

◆Development and validation of analytical methods for elemental impurities

◆Elemental impurities analysis

◆Elemental classification according to ICH Q3D 


Classification

Elemental Impurities

Class 1

Cd，Pb，As，Hg

Class 2A

Co，V，Ni

Class 2B

Ti，Au，Pd，Ir，Os，Rh，Ru，Se，Ag，Pt

Class 3

Li，Sb，Ba，Mo，Cu，Sn，Cr



         Elemental Impurities Solution：

◆Elemental impurities scanning: Compare with the blank solution by ICP-MS scanning

◆Methods development

◆Methods validation: Comprehensive validation of analytical methods; Validation protocol and report in Bilingual；Support dual submission in China and United States.

◆Assessment report of elemental impurities

 



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