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Analysis of High Molecular Impurities in Insulin Aspart According to Pharmacopeia Method (KW-802.5)

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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)
- -

Sample : 100 μL
System suitability solution (prepared according to JP method)
1. Dimer
2. Insulin aspart

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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