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Psychol Med 2014

Stability Study Protocol Guideline:ICH Q1A(R2) Stability Testing, ICH Q1B Photostability Protocol No.:STAB-SM10-2026-01 Batch No.:COA-SM10-6343 Packaging:Amber glass vial, PTFE-lined cap, N backfill, secondary PE bag + desiccant Accelerated Conditions:40C 2C / 75% RH 5% RH (ICH Zone IVb) Long-term Conditions:25C 2C / 60% RH 5% RH Photostability:ICH Option 2: 1.2 million luxhours + 200 Wh/m near-UV Parameters Monitored:Appearance, Assay (HPLC), Impurities, Moisture (KF), Sterility Timepoints:0, 1M, 2M, 3M, 6M (accel.)

Weekly injection at your assigned dose is designed to maximize efficacy while minimizing adverse events

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