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Case Study: Meeting System Suitability using <621> Allowable Adjustments for USP Abacavir and Lamivudine Tablets Assay
Abacavir and Lamivudine in combination are used with other medications to treat Human Immunodeficiency Virus (HIV) infection. The USP monograph for the tablets assay describes a separation utilizing an L1 column. In this case study we will demonstrate that using allowable adjustments it is possible to successfully replace the original column, an XTERRA® 3.5 µm MS C18 column, with either another fully porous column, Luna™ Omega 3 µm C18, or alternatively with a core-shell, Kinetex™ 2.6 µm EVO C18 column. Both columns are considered as alternative L1 columns.
Case Study: Meeting System Suitability using <621> Allowable Adjustments for USP Abacavir and Lamivudine Tablets Assay
Abacavir and Lamivudine in combination are used with other medications to treat Human Immunodeficiency Virus (HIV) infection. The USP monograph for the tablets assay describes a separation utilizing an L1 column. In this case study we will demonstrate that using allowable adjustments it is possible to successfully replace the original column, an XTERRA® 3.5 µm MS C18 column, with either another fully porous column, Luna™ Omega 3 µm C18, or alternatively with a core-shell, Kinetex™ 2.6 µm EVO C18 column. Both columns are considered as alternative L1 columns.
Document Type:
Technical Notes
Target Industries:
Techniques:
Brands:
Separation Modes:
Reversed Phase
Phases:
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Case Study: Meeting System Suitability using <621> Allowable Adjustments for USP Abacavir and Lamivudine Tablets Assay
Abacavir and Lamivudine in combination are used with other medications to treat Human Immunodeficiency Virus (HIV) infection. The USP monograph for the tablets assay describes a separation utilizing an L1 column. In this case study we will demonstrate that using allowable adjustments it is possible to successfully replace the original column, an XTERRA® 3.5 µm MS C18 column, with either another fully porous column, Luna™ Omega 3 µm C18, or alternatively with a core-shell, Kinetex™ 2.6 µm EVO C18 column. Both columns are considered as alternative L1 columns.
| Target Industries: | Pharmaceutical |
| Techniques: | HPLC, HPLC Reversed Phase |
| Brands: | Kinetex, Luna Omega |
| Separation Modes: | Reversed Phase |
| Phases: | Kinetex EVO C18, Luna Omega C18 |
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