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Analytical Support 

Formosa Labs has a dedicated and experienced analytical team providing comprehensive analytical support spanning early stage development through commercial API manufacturing. We understand the importance of timely and quality analytical support to the success of your project. Therefore, we maintain a high ratio of analytical support to chemists and engineers on a project.

     

 

Formosa Labs’ analytical capabilities for the support of cGMP/API manufacturing processes include:
· Methods development
Methods validation
Specification development/material testing
Structural analysis
Impurity isolation and identification
Product characterization and purity assessment (HPLC/UPLC, GC, GCMS, LCMS, Heavy Metals, Karl Fischer)
ICH stability studies (storage and testing)
Reference standard qualification
API solids characterization
Cleaning method development and validation
Test and release of starting materials, intermediates and final products
Impurity profiling

 

 

 

 

 
 
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