N-Nitroso Bilastine impurity 6

N-Nitroso Bilastine Impurity 6 (CAS No.: NA), Molecular Formula C₁₅H₁₈N₄O₃, Molecular Weight 302.33 g/mol, is a high-quality pharmaceutical reference standard intended for analytical research, nitrosamine impurity analysis, impurity profiling, and pharmaceutical quality control. It is widely used for HPLC method development, HPLC method validation, UHPLC, LC-MS, LC-MS/MS, HRMS, Mass Spectrometry, ¹H NMR, ¹³C NMR, FTIR, and other advanced analytical testing techniques to support accurate identification and quantification of Bilastine-related nitrosamine impurities. This reference standard is suitable for analytical method development, analytical method validation, stability-indicating methods, forced degradation studies, quality control (QC), quality assurance (QA), pharmaceutical R&D, CROs, CDMOs, and regulatory analytical testing. It supports impurity characterization and regulatory submissions in accordance with internationally recognized pharmaceutical guidelines, including ICH Q2(R2) for analytical procedure validation, ICH Q3A and ICH Q3B for impurity assessment, ICH M7 for the assessment and control of DNA-reactive (mutagenic) impurities including nitrosamines, as well as Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) requirements. N-Nitroso Bilastine Impurity 6 is intended exclusively for laboratory research, pharmaceutical analytical testing, method development, quality control, and regulatory compliance applications and is not intended for human or veterinary use.