Your Partner to Fast-Track Trace Metals Analysis

Our Capabilities

  • Development and Validation studies designed as per ICH Q3D and USP <232 >/ <233> for Active pharmaceutical ingredients, intermediates and drug products
  • Determination of Class 1, 2A, 2B, 3 and other elements like Aluminium (Al), Boron (B), Calcium (Ca), Iron (Fe), Potassium (K), Magnesium (Mg), Manganese (Mn), Tungsten (W) and Zinc (Zn)
  • Provide solutions for analysing the critical elements like Zirconium (Zr), Silicon (Si) and Sodium (Na) in drug product & Excipients
  • Ability to develop single ICP-MS method for 24 elements
  • Detailed risk assessment report for drug product which suits to regulatory filings like ANDA, NDA etc.

Why Aragen

  • Expertise on wide element coverage (72 elements)
  • Executed 200 method developments and validations on ICP-MS
  • Rapid multi-element quantitative analysis
  • Low detection limits with high sensitivity
  • Quick turnaround time
  • Dedicated team of 30 Analytical scientists for analytical development, analytical method validation and routine analysis
  • Project Management support to ensure seamless execution