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Aggregate Analysis of Insulin Analogues Using a Biozen dSEC-1 SEC Column
This technical note demonstrates the reliable performance of Biozen dSEC-1 SEC columns for detecting and quantifying aggregates in insulin analogues, a critical quality attribute for therapeutic peptides. Using USP 121.1 conditions, both 150 mm (1.6 um) and 300 mm (3 um) columns achieved baseline resolution (Rs > 1.5) between insulin monomers and dimers, with excellent reproducibility (retention time RSD ≤ 0.2%, peak area RSD ≤ 4.7%) and peak symmetry within USP limits. The study confirms Biozen dSEC-1 as a robust solution for routine aggregate analysis of insulin glargine and lispro.
Aggregate Analysis of Insulin Analogues Using a Biozen dSEC-1 SEC Column
This technical note demonstrates the reliable performance of Biozen dSEC-1 SEC columns for detecting and quantifying aggregates in insulin analogues, a critical quality attribute for therapeutic peptides. Using USP 121.1 conditions, both 150 mm (1.6 um) and 300 mm (3 um) columns achieved baseline resolution (Rs > 1.5) between insulin monomers and dimers, with excellent reproducibility (retention time RSD ≤ 0.2%, peak area RSD ≤ 4.7%) and peak symmetry within USP limits. The study confirms Biozen dSEC-1 as a robust solution for routine aggregate analysis of insulin glargine and lispro.
Document Type:
Technical Notes
Target Industries:
Brands:
Separation Modes:
Size Exclusion
Phases:
Aggregate Analysis of Insulin Analogues Using a Biozen dSEC-1 SEC Column
This technical note demonstrates the reliable performance of Biozen dSEC-1 SEC columns for detecting and quantifying aggregates in insulin analogues, a critical quality attribute for therapeutic peptides. Using USP 121.1 conditions, both 150 mm (1.6 um) and 300 mm (3 um) columns achieved baseline resolution (Rs > 1.5) between insulin monomers and dimers, with excellent reproducibility (retention time RSD ≤ 0.2%, peak area RSD ≤ 4.7%) and peak symmetry within USP limits. The study confirms Biozen dSEC-1 as a robust solution for routine aggregate analysis of insulin glargine and lispro.
| Target Industries: | Biopharmaceutical Analysis |
| Techniques: | HPLC, HPLC-SEC |
| Brands: | Biozen LC |
| Separation Modes: | Size Exclusion |
| Phases: | Biozen dSEC-1 |
Phenomenex is a technology leader committed to developing novel analytical chemistry solutions that solve the separation and purification challenges of researchers worldwide.
Phenomenex is a technology leader committed to developing novel analytical chemistry solutions that solve the separation and purification challenges of researchers worldwide.