Analytical Development

• 3.3 Analytical Development

3.3.1 Method Development

• Techniques: HPLC/UPLC (assay, impurities), GC (residual solvents), and dissolution testing (USP Apparatus I–IV).

• Validation: ICH Q2(R1)-aligned specificity, accuracy, precision, and robustness studies.

• Compliance: Ensure methods meet FDA/EMA requirements for ANDA/NDA submissions.

3.3.2 Analytical Testing

• Routine Testing: Assay, content uniformity, disintegration, and microbial limits (USP <61>/<62>).

• Specialized Testing: Extractables/leachables (GC-MS), particle size distribution (Malvern), and NMR for structure elucidation.

• Data Integrity: ALCOA+ principles with 21 CFR Part 11-compliant LIMS (Lab Information Management System).