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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. Insulin aspart is part of the rapid-acting type and it is listed in the U.S. Pharmacopoeia (USP 40), European Pharmacopoeia (EP 9.0) and Japanese Pharmacopoeia (JP 17 Supplement I). System suitability for the analysis of high molecular impurities in insulin aspart in each pharmacopoeia is as follows. It was confirmed that the all conditions were satisfied when they were analyzed using PROTEIN KW-802.5.

System suitability

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

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