(R)-2-Hydroxy-N-(4-nitrophenethyl)-N-nitroso-2-phenylacetamide

As an essential reference material for Mirabegron impurity testing and regulatory compliance, (R)-2-Hydroxy-N-(4-nitrophenethyl)-N-nitroso-2-phenylacetamide (Formula C₁₆H₁₅N₃O₅; Molecular Weight 329.3 g/mol) is synthesized and globally distributed by Manasa Life Sciences. Operating under strict GMP and GDP frameworks, we supply top-tier reference standards to pharmaceutical manufacturers, analytical laboratories, and quality control teams across Asia, Europe, Africa, the GCC, and the UAE. Designed to satisfy stringent USP, EP and ICH M7 safety thresholds, this N-nitroso impurity standard enables accurate quantification during ultra-trace LC-MS method validation and routine API quality release. Every shipment is backed by exhaustive multi-technique analytical profiling including HPLC assay, LC-MS mass verification, NMR structural elucidation, and IR testing and comes fully supported with a batch-specific COA and MSDS to accelerate ANDA/NDA filings with the USFDA and EMA.