Raw Materials & APIs Quality Control

Testing raw materials, excipients and active pharmaceutical ingredients (APIs) is essential for quality control in pharmaceutical industry. It is mandatory to ensure that the final product released on the market is safe and effective. Therefore, the necessary tests are conducted and starting materials are released only once their identity, purity and quality is proved. 

Selvita offers services starting from compendial methods verification/qualification via new analytical methods development and validation, through to routine quality control testing under cGMP regulations. Our capabilities cover extensive areas of competencies, using various techniques: 

• Compendial testing (EP, USP, BP) 
• Physicochemical properties (KF, LOD, osmolality and osmolarity, logD, pKa, melting/freezing point, IR, NMR, hardness, pH, viscosity) 
• Identity and purity 

• Impurity profiling and identification 
• Residual solvents determination 
• Metal analysis 
• Cleaning validation 
• Genotoxicity testing (MPF Ames test OECD 471; MNA OECD 487; MLA OECD 4 90)