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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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