Acebutolol EP Impurity J

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Manasa Life Sciences is a specialized manufacturer and supplier of high-purity Acebutolol EP Impurity J (N-Desisopropyl-N-Methyl Acebutolol), identified by CAS No. 28197-36-6, with the molecular formula C₁₇H₂₆N₂O₄ and molecular weight 306.40 g/mol. This Acebutolol-related analytical impurity is systematically identified as N-[3-acetyl-4-[(2RS)-2-hydroxy-3-(methylamino)propoxy]phenyl]prop-2-enamide and is supplied in pharmaceutical analytical applications. It is characterized using advanced analytical techniques, including HPLC, LC-MS, NMR, and IR spectroscopy, supporting impurity profiling, related-substance analysis, analytical method development, method validation, stability studies, and pharmaceutical quality-control testing. Manasa Life Sciences follows robust quality-management and documentation practices aligned with applicable USP, Ph. Eur. (EP), USFDA, EMA, ICH, GMP, and GDP requirements. Each batch is supplied with comprehensive documentation, including a Certificate of Analysis (CoA) and Safety Data Sheet (SDS/MSDS), ensuring traceability, consistent quality, and reliable performance as an analytical reference standard for pharmaceutical research and quality assurance.

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