Analytical

Rushi Pharma provides comprehensive analytical research and development support for APIs, intermediates, and New Chemical Entities (NCEs), aligned with pharmaceutical regulatory expectations.

Core Analytical Capabilities:

Analytical Method Development & Validation:

• Reverse phase, normal phase & chiral HPLC method development
• HPLC systems with PDA, RI, CAD & ELSD detectors
• GC & Headspace GC (OVI analysis)
• Analytical method transfer to quality control units
• Preparation of analytical tech packs

Impurity Profiling & Characterization:

• Comprehensive impurity profiling
• Structure elucidation using LC-MS & GC-MS
• Impurity isolation & characterization
• Stability-indicating method development

Solid-State & Advanced Studies:

• Salt screening
• Polymorph identification
• Compatibility studies in coordination with formulation team

Solid-State & Advanced Studies:

• Preparative HPLC (achiral & chiral separation)
• Isolation of reference standards and impurities

Quality & Compliance Focus:

• Instrument calibration as per scheduled protocols
• Documentation alignment for regulatory submissions
• Method robustness and reproducibility emphasis
• Support for development and cGMP environments