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Separation of Irinotecan Hydrochloride and its Chiral Impurity per USP Monograph under Allowable Adjustments
Irinotecan hydrochloride is a chemotherapeutic agent classified as a DNA topoisomerase I inhibitor. Irinotecan is frequently administered alongside other drugs for the treatment of metastatic colon and rectal cancer, and occasionally for small cell lung cancer. The USP monograph specifies the use of an L40 column (4.6-mm × 25-cm; 10-µm), which is a Cellulose tris (3,5 dimethylphenylcarbamate) polymer column. In this technical note we demonstrate the utilization of Lux™- Cellulose-1, (5 µm 150 x 4.6 mm) as an alternative column for the separation of Irinotecan Hydrochloride and its chiral impurity per the allowable adjustments outlined in USP General Chapter <621>. The system Suitability per USP monograph is resolution NLT 2.5 between Irinotecan related compound D and Irinotecan, a percent relative standard deviation (%RSD) of NMT 5.0%, for standard solution and the Irinotecan related compound D peak should be visible for the sensitivity solution. All the system suitability requirements have been met by this column.
Separation of Irinotecan Hydrochloride and its Chiral Impurity per USP Monograph under Allowable Adjustments
Irinotecan hydrochloride is a chemotherapeutic agent classified as a DNA topoisomerase I inhibitor. Irinotecan is frequently administered alongside other drugs for the treatment of metastatic colon and rectal cancer, and occasionally for small cell lung cancer. The USP monograph specifies the use of an L40 column (4.6-mm × 25-cm; 10-µm), which is a Cellulose tris (3,5 dimethylphenylcarbamate) polymer column. In this technical note we demonstrate the utilization of Lux™- Cellulose-1, (5 µm 150 x 4.6 mm) as an alternative column for the separation of Irinotecan Hydrochloride and its chiral impurity per the allowable adjustments outlined in USP General Chapter <621>. The system Suitability per USP monograph is resolution NLT 2.5 between Irinotecan related compound D and Irinotecan, a percent relative standard deviation (%RSD) of NMT 5.0%, for standard solution and the Irinotecan related compound D peak should be visible for the sensitivity solution. All the system suitability requirements have been met by this column.
Document Type:
Technical Notes
Target Industries:
Techniques:
Brands:
Separation Modes:
Chiral
Phases:
Separation of Irinotecan Hydrochloride and its Chiral Impurity per USP Monograph under Allowable Adjustments
Irinotecan hydrochloride is a chemotherapeutic agent classified as a DNA topoisomerase I inhibitor. Irinotecan is frequently administered alongside other drugs for the treatment of metastatic colon and rectal cancer, and occasionally for small cell lung cancer. The USP monograph specifies the use of an L40 column (4.6-mm × 25-cm; 10-µm), which is a Cellulose tris (3,5 dimethylphenylcarbamate) polymer column. In this technical note we demonstrate the utilization of Lux™- Cellulose-1, (5 µm 150 x 4.6 mm) as an alternative column for the separation of Irinotecan Hydrochloride and its chiral impurity per the allowable adjustments outlined in USP General Chapter <621>. The system Suitability per USP monograph is resolution NLT 2.5 between Irinotecan related compound D and Irinotecan, a percent relative standard deviation (%RSD) of NMT 5.0%, for standard solution and the Irinotecan related compound D peak should be visible for the sensitivity solution. All the system suitability requirements have been met by this column.
| Target Industries: | Pharmaceutical |
| Techniques: | HPLC-Chiral |
| Brands: | Lux |
| Separation Modes: | Chiral |
| Phases: | Lux Cellulose-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.