Products Tested

Active Pharmaceutical Ingredients

NDA Analytics has extensive experience of testing active pharmaceutical ingredients (APIs), including freeze-dried materials. A broad range of tests for APIs can be provided including:

• Assay of active ingredient
• Assay of related impurities and degradation products
• Impurity limit tests
• Identification by FTIR spectroscopy
• Identification by UV/visible spectroscopy
• Identification by mass spectroscopy
• Identification by NMR
• Optical rotation measurement
• Refractive index measurement
• Water content by Karl-Fischer titration
• Loss on drying
• Melting point determination
• C/H/N Analysis
• Residual solvents assay
• Microbial limit tests
• Pharmacopoeia tests