Analytical & Bioanalytical Service

Analytical & Bioanalytical Service

Analytical​ Bioanalytical Chemistry 

Tou Pharma Bio’s experienced team of analytical chemists in the field of development and validation of stability developed methods to be used to quantitate drug substance purity and percentage drug content in a dosage form, including impurities and degradation products.  The method is further used to measure conformity to dosage form specifications including dissolution, presence of related substances and product stability.  

Tou Pharma Bio provides the following analytical chemistry services.

• 1. Reference standard characterization 
• 2. Drug substance characterization
• 3. Analytical methods development 
• 4. Analytical methods qualification 
• 5. Analytical methods validation 
• 6.  Analytical methods transfer 
• 7.  Release testing of bulk materials 
• 8. Release testing of API 
• 9. Release testing of drug product 
• 10. In-process testing 
• 11. Stability study protocol preparation 
• 12. Photostability study testing 
• 13. Dissolution study testing
• 14. cGMP formal stability study program protocols and testing according to ICH Guidelines 
• 15. Dose verification analysis of animal study materials 
• 16. Dose verification analysis of clinical trial materials