• Stability Storage
  
  
• Thermal Cycling
  Stability Testing
  
  
• Photostability Testing & Photodegradation Studies
  
  
• Clinical Registration &
  Annual Stability Studies
  
  
• Blind Comparator
  Stability Studies
  
  
• Formulation Development
  & Optimization


• Method Development
  and Validation
  
  
• USP Testing
  
  
• In-process and Lot
  Release Testing
  
  
• Raw Material Testing

Boston Analytical helps qualify your incoming raw materials through a number of USP raw material test methods. Our trained and qualified analysts perform identification tests, limit tests, and a number of physical tests to verify that your APIs meet compendial standards and qualify for use in your manufacturing processes. Below is a partial listing of our API raw material testing services:

Limit Tests and Physical Tests Heavy Metals USP <231> Methods I and II Residue on Ignition USP <281> Residual Solvents USP <467> Loss on Drying USP <731> Loss on Ignition USP <733> Melting Range or Temperature USP <741> Optical Rotation USP <781> Osmolality / Osmolarity USP <785> Particulate Matter in Injections USP <788> Particulate Matter in Ophthalmics USP <789> pH USP <791> Specific Gravity <841> Viscosity Testing USP <911> Karl Fisher Moisture USP <921> Methods 1a and 1c

Identification Testing

• General ID Tests USP <191>
• Spectrophotometric ID Test USP <197>  UV-Vis , FTIR, HPLC
• Thin Layer Chromatography TLC USP <201>