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
