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*), “Impurities with molecular masses greater than that of teriparatide” for “Teriparatide" should be carried out with a column filled with hydrophilic silica gel, suitable for protein separation up to a molecular weight of 150,000. The PROTEIN KW-802.5 confirmed the requirement was met.

System suitability requirementResolution between peaks of teriparatide dimer and teriparatide monomer (Resolution solution): ≥ 2.0

*The version at the time of the application acquisition.

Sample: 20 µL
(Resolution solution) 1.0 mg/mL of Teriparatide** in H2O
**pretreated at 75 ℃ for 24 hours

  1. 1.Trimer
  2. 2.Dimer
  3. 3.Monomer
Column
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 ℃

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