N-Nitroso bilastine impurity 9

N-Nitroso Bilastine Impurity 9 (CAS No.: NA; Molecular Formula: C₂₄H₂₆N₄O₄; Molecular Weight: 434.49 g/mol) is a high-quality nitrosamine impurity reference standard manufactured and supplied by Manasa Life Sciences, a trusted manufacturer and supplier in India, for pharmaceutical research, analytical method development, impurity profiling, stability studies, and quality control applications. Our expert scientists perform comprehensive characterization using advanced analytical techniques, including HPLC, UPLC, LC-MS/MS, HRMS, Mass Spectrometry (MS), ¹H NMR, and ¹³C NMR, to confirm identity, purity, and structural integrity. This reference standard supports pharmaceutical manufacturers, CROs, and analytical laboratories in developing and validating analytical methods and conducting nitrosamine impurity assessments in accordance with internationally recognized regulatory guidelines, including ICH, USP, European Pharmacopoeia (EP/Ph. Eur.), European Medicines Agency (EMA), and U.S. Food and Drug Administration (US FDA) recommendations. Each qualified batch undergoes stringent Quality Control (QC) testing and is supplied with comprehensive documentation, including a Certificate of Analysis (COA), Safety Data Sheet (SDS), Material Safety Data Sheet (MSDS), product specifications, analytical data, and Good Distribution Practice (GDP)-compliant documentation to support pharmaceutical quality systems and regulatory submissions. Intended exclusively for laboratory research and analytical use, N-Nitroso Bilastine Impurity 9 serves as a reliable reference standard for impurity identification, quantification, chromatographic method validation, and pharmaceutical quality assurance, making Manasa Life Sciences a preferred partner for pharmaceutical companies and research organizations worldwide.