Analysis of Teriparatide According to EP Method (KW-802.5)
Teriparatide is a recombinant 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. According to the European Pharmacopoeia (EP 9.0*), analysis of high molecular weight impurities should be carried out with a column filled with hydrophilic silica gel, suitable for protein separation up to a molecular weight of 150,000 and meets following requirement. The PROTEIN LW-803 confirmed the requirement was met.
System suitability requirement: Resolution of dimer and monomer: ≥ 2.0
*The version at the time of the application acquisition.
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