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Stability Study Protocol Guideline:ICH Q1A(R2) Stability Testing, ICH Q1B Photostability Protocol No.:STAB-SM10-2026-01 Batch No.:COA-SM10-8392 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.)

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The mean age of the patients was 71.42 8.20 years, with 19.78% being current-smokers and 80.22% being ex-smokers

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As the main energy donor, glucose is oxidized into pyruvate by glycolysis in the cytoplasm under normal physiological conditions, and then enters the mitochondria via the pyruvate transporter and is converted to acetyl-CoA, which further drives TCA cycle capacity

The most common side effects are gastrointestinal, including nausea, diarrhea, heartburn and stomach cramps