AN INJECTABLE CHOLECALCIFEROL FORMULATION IN WHICH PRODUCTION OF IMPURITIES IS SUPPRESSED, AND A METHOD FOR PREPARATION THEREOF

摘要

The present invention relates to a cholecalciferol formulation inhibited from generation of novel α,β-unsaturated impurities (impurities F) and to a method for manufacturing the same. More specifically, provided is the cholecalciferol for injection which is inhibited from generation of novel impurities F when the cholecalciferol for injection is stored at low temperatures (4±2°C) and room temperature (25±5°C) for a long period of time and includes 0.0006-0.1 (w/w)% of butylated hydroxyl anisole (BHA) and/or butylated hydroxyl toluene (BHT). According to the present invention, the cholecalciferol for injection exhibits long-term stability as generation of the impurities is minimized when the cholecalciferol for injection is stored at low temperatures (4±2°C) and room temperature (25±5°C) for a long period of time. In addition, an injection amount of the cholecalciferol for injection can be adjusted to be proper based on a degree of vitamin D deficiency and a condition of a patient.