Teriparatide is a peptide (molecular weight about 4,100) that corresponds to amino acids 1st to 34th of human parathyroid hormone, and is a drug used to treat osteoporosis. In the analysis of high molecular weight impurities by the European Pharmacopoeia (EP 9.0), a hydrophilic silica gel column suitable for protein separation up to a molecular weight of 150,000 is used. As a system suitability, the degree of separation between dimer and monomer is required to be 2.0 or higher. When analysis was performed using PROTEIN KW-802.5, it was confirmed that the system suitability was fully satisfied.
Sample : 20 μL
Teriparatide (pretreated at 75 °C for 24 hours)
1.0 mg/mL (in H2O)
1. Trimer
2. Dimer
3. Monomer
Columns : Shodex PROTEIN KW-802.5 (8.0 mm I.D. x 300 mm) Eluent : H2O/CH3CN/TFA=750/250/1 Flow rate : 0.5 mL/min Detector : UV (214 nm) Column temp. : 25 °C
