Insulin preparations are classified into six categories by type of action, including rapid-acting type, short-acting type, and long-acting type.
According to the United States Pharmacopeia and the National Formulary (USP40-NF35*), the European Pharmacopoeia (EP 9.0*), and the Japanese Pharmacopoeia (JP; 17 Supplement I*), analysis of insulin aspart, a part of rapid-acting type, should meets following requirements. The PROTEIN KW-802.5 confirmed the requirements were met.
*The version at the time of the application acquisition.
System Suitability Requirements
JP | USP-NF | EP | |
Test for required detectability | The area percentage of the dimer peak of the two-fold diluted system suitability test solution is 80 to 120% of the area percentage of the dimer peak of the system suitability test solution. | - | - |
Retention | Insulin aspart polymer (13 to 17 min) Insulin aspart dimer (about 17.5 min) Insulin aspart (18 to 20 min) |
The polymeric complexes (13 to 17 min) The dimer (about 17.5 min) The monomer (18 to 22 min) |
The polymeric complexes (13 to 17 min) The dimer (about 17.5 min) The monomer (about 20 min) |
Peak-to-valley ratio | ≥ 2.0 | ||
Relative standard deviation (RSD) of peak area of the monomer | ≤ 2.0% (repeated six times) |
- | - |
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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