Impurity Root Cause Analysis for Formulations :
- Target Excipients Causing Impurities at Specific Weight Fractions : Identify which excipients are causing impurity formation at given formulation weight fractions, helping you optimize formulations and reduce impurity risk.
- Enhance Assay Accuracy & Stability : Improve assay accuracy and overall formulation stability by addressing impurity-prone combinations and adjusting the excipient ratios as needed.
- Analyse Impurity Formation Under ICH Conditions : Assess impurity formation at ICH conditions (25°C/60% RH & 40°C/75% RH), ensuring formulations meet regulatory stability requirements across different environmental factors.
- Predictive Impurity Control to Reduce Time-to-Market : Reduce time-to-market by up to 60% by predicting impurity issues early and controlling them proactively, speeding up development timelines.