T/CPCIF 0227-2022 N-Boc-L-phenylalanine (for industrial use)
T/CPCIF 0227-2022 N-Boc-L-phenylalanine (for industrial use)
Basic Information
Scope
Scope: This document specifies the requirements, test methods, inspection rules, marking, labels and accompanying documents, packaging, transportation, and storage of N-tert-butoxycarbonyl-L-phenylalanine for industrial use. This document applies to N-tert-butoxycarbonyl-L-phenylalanine prepared by amination reaction using tert-butyl dicarbonate and L-phenylalanine as the main raw materials. This product is mainly used in the synthesis of pharmaceutical intermediates. Main technical content: - Item Requirements: High-purity qualified products should have a white to off-white crystalline appearance. The mass fraction of N-tert-butoxycarbonyl-L-phenylalanine shall be determined by liquid chromatography (%). - Test Methods: - Titration method: The mass fraction of N-tert-butoxycarbonyl-L-phenylalanine shall be 99.0% to 101.5%. - Single impurity limit: The maximum single impurity shall not exceed 0.1%. - N-tert-butoxycarbonyl-D-phenylalanine mass fraction: The mass fraction of N-tert-butoxycarbonyl-D-phenylalanine shall not exceed 0.1%. - Melting point range/℃: 85–88°C. - Specific rotation: +24.0° to +27.0°. - Water content: Not more than 0.5%.