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Analysis of Insulin Human According to JP Method (KW-802.5)


According to the Japanese Pharmacopeia (JP; 17th edition*), analysis of high-molecular proteins in insulin human (genetical recombination) should be carried out with a column filled with hydrophilic silica gel and meets following requirement. The PROTEIN KW-802.5 confirmed the requirement was met.

System suitability requirement:
   H1/H2:≥ 2.0
Where H1 is the peak height of the dimer and H2 is the height of the bottom between the peaks of the dimer and the monomer.

*The version at the time of the application acquisition.

Sample : 100 μL
4.0mg/mL of human Insulin containing dimer (in 0.01 N HCl aq.)
1. High molecular weight proteins
2. Insulin trimer
3. Insulin dimer
4. Insulin monomer

Column       : Shodex PROTEIN KW-802.5 (8.0 mm I.D. x 300 mm)
Eluent       : 0.1 wt% L-Arginine aq./CH3CN/CH3COOH=13/4/3
Flow rate    : 0.5 mL/min
Detector     : UV (276 nm)
Column temp. : 25 °C

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