METHOD FOR COMPARING AND EVALUATING OF THE STRUCTURE OF BIOSIMILARS USING NUCLEAR MAGNETIC RESONANCE SPECTROMETER

摘要

PURPOSE: A comparison evaluation method of equivalent creature drug structure, using a NMR spectroscopy is provided to use one-dimension first 1H-NMR or two-dimension 1H-13C HSQC spectrum about an equivalent creature drug structure without a pre-processing step. CONSTITUTION: A comparison evaluation method of equivalent creature drug structure is as follows. The creature drug sample is analyzed by using NMR spectroscopy. The one-dimension 1H-NMR spectrum is obtained from a sample which analyzes by using the NMR spectroscopy. The one-dimension 1H-NMR spectrum obtains data for 30 seconds ~3 minutes. Two dimension 1H-13C HSQC spectrum is obtained from the sample which analyzes by using the NMR spectroscopy. Two dimension 1H-13C HSQC spectrum obtains data for a ~30 minute and 3 hours.