N-Nitroso bilastine impurity 8

N-Nitroso Bilastine Impurity 8 (CAS No.: NA; Molecular Formula: C₂₈H₃₅N₅O₂; Molecular Weight: 473.61 g/mol) is a premium-quality Bilastine nitrosamine impurity reference standard manufactured and supplied by Manasa Life Sciences, a trusted manufacturer and supplier in India, for pharmaceutical research, impurity profiling, analytical method development, nitrosamine risk assessment, 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 verify identity, purity, and structural integrity. This pharmaceutical reference standard supports API manufacturers, formulation companies, CROs, and quality control laboratories in developing and validating analytical methods while meeting global regulatory expectations, including ICH, USP, European Pharmacopoeia (EP/Ph. Eur.), European Medicines Agency (EMA), and U.S. Food and Drug Administration (US FDA) guidelines for nitrosamine impurity analysis and pharmaceutical compliance. Each qualified batch undergoes stringent Quality Control (QC) testing and is supplied with complete documentation, including a Certificate of Analysis (COA), Safety Data Sheet (SDS), Material Safety Data Sheet (MSDS), analytical reports, product specifications, and Good Distribution Practice (GDP)-compliant documentation to support regulatory submissions and laboratory quality systems. Intended exclusively for laboratory research and analytical use, N-Nitroso Bilastine Impurity 8 is an ideal Bilastine impurity standard, pharmaceutical reference material, nitrosamine analytical standard, HPLC reference standard, LC-MS reference standard, and quality control reference standard for impurity identification, quantification, method validation, and pharmaceutical quality assurance.