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Brain-penetrating neurotrophic factor mimetics: HER-096 as a disease-modifying therapy for Parkinson’s disease

Neural Regeneration Research 2025年第4期20卷 1094-1095页

作者： Natalia Kulesskaya Kira M.Holmström Henri J.Huttunen herantis pharma plc EspooFinland

Neurotrophic factors as a therapeutic approach in neurodegenerative diseases:A major unmet need in the field of central nervous system diseases is disease-modifying *** for decades there have been various symptomatic treatments available to alleviate the symptoms of the disease,disease-modification,*** that stop,significantly delay,or reverse the progression of the disease,has been turned out to a difficult goal to achieve.

关键词： diseases treatment therapeutic

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Development and Validation of Stability Indicating Rapid RP-LC Method for Determination of Process and Degradation Related Impurities of Apremilast, an Anti-Inflammatory Drug

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American Journal of Analytical Chemistry 2017年第6期8卷 380-394页

作者： Shashikant B. Landge Sunil B. Dahale Sanjay A. Jadhav Pavankumar V. Solanki Saroj R. Bembalkar Vijayavitthal T. Mathad Department of Process Research and Development Megafine Pharma (P) Ltd. Maharashtra India Department of Chemistry Deogiri College Aurangabad India

A new, specific, rapid and stability indicating reversed phase liquid chro-matographic (RP-LC) method for the determination of process related and degradation related impurities of Apremilast has been developed and validated. The degradation study performed in acid, base, oxidative, photolytic, and thermal stressed conditions. Eight process related impurities (Imp-1 to Imp-8) in test sample of Apremilast have been detected by developed RP-LC method. The good chromatographic resolution between the peaks of process related impurities, degradation impurities and Apremilast has been achieved on a Synergi Max-RP 80 A (150 × 4.6 mm ID), 4 μ column. The process and degradation related impurities were characterized by mass spectrometry, 1H NMR and FT-IR spectral data. The method was validated as per ICH guideline and found to be specific, rapid, and stability indicating. The proposed RP-plc method was successfully applied to the analysis of drug substance samples of Apremilast.

关键词： Apremilast Stability Indicating RP-LC PDE4 Inhibitor Forced Degradation

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