2 results about "Rocuronium Bromide" patented technology

This invention provides a method for preparing rocuronium bromide injection. By optimizing the conventional moist heat sterilization process, specifically by increasing the initial temperature of the heating process and decreasing the initial temperature of the cooling process, the overall exposure time of the injection to high temperatures is significantly shortened while maintaining the sterilization time at 121°C, thus significantly improving the quality stability of rocuronium bromide injection. Multiple batches of samples from this invention have met the related substance limits for rocuronium bromide injection as specified in the Chinese Pharmacopoeia, after accelerated stability and long-term stability studies.

According to an embodiment of the present disclosure, the room-temperature stable, unbuffered rocuronium injection formulation for intravenous administration comprises of 1% w / v of rocuronium bromide, a pH adjusting agent comprising hydrochloric acid at a concentration between 12.5 mMol and 20 mMol for the adjustment of pH between 3.5 to 4.5 and a quantity sufficient of water to make the formulation to 1 mL. The proposed formulation of the present disclosure is stabilized through optimization of pH of the formulation using only hydrochloric acid and / or sodium hydroxide as the pH adjusting agents without use of any buffering agents is suitable for moist heat sterilization. Further, the rocuronium injection formulation of the present disclosure contains lower than 3% of rocuronium related compound C, more preferably less than 2% over the stability period at room temperature conditions.