Somatropin is a genetical recombinant natural type human growth hormone preparation, a peptide consisting of 191 amino acids (molecular weight about 22,000). According to the European Pharmacopoeia (EP 9.5*), “Dimer and related substances of higher molechular mass” for “Somatropin" should be carried out with a column filled with hydrophilic silica gel, suitable for protein separation in the molecular weight range of 5,000 to 150,000. The PROTEIN LW-803 confirmed the requirement was met. In addition, use of LW-803 achieved about 5 times better peak/valley ratio and clearer detection of tetramer when compared with other company’s equivalent column.

System suitability requirementThe peak-to-valley ratio** (Resolution solution): ≥ 2.5

*The version at the time of the application acquisition.
**The ratio of the height of the dimer peak to the height of the valley between the dimer peak and the monomer peak.

Sample: 20 µL
(Resolution solution) 1.0 mg/mL of Somatropin*** in 0.025 M phosphate buffer (pH7.0)
***pretreated at 50 ℃ for 24 hours

1. 1.Tetramer
2. 2.Trimer
3. 3.Dimer
4. 4.Monomer