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Analysis of Insulin According to USP-NF Method (KW-802.5)

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According to the United States Pharmacopeia and the National Formulary (USP 39-NF 34*), analysis of high molecular weight proteins in insulin should be carried out with a column filled with L20 packing material and meets following requirements. The PROTEIN KW-802.5 confirmed the requirements were met.

System suitability requirements:
  Retention times:
         Polymeric insulin complexes: 13 to 17 min
         Covalent insulin dimer: about 17.5 min
         Insulin monomer: 18 to 22 min
    Peak-to-valley ratio**: ≥ 2

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


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