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USP Vardenafil Hydrochloride Assay and Organic Impurities on Gemini 5 µm C18 and Gemini 5 µm NX-C18 (AN-1014)
This application note for the LC-UV assay and organic impurities for Vardenafil hydrochloride drug substance is based on the official USP monograph which calls for an L1 (C18) 5 µm, 250 x 3.0 mm column under gradient conditions for both assay and organic impurities. The mobile phase, standard solution, and system suitability solution for the assay and organic impurities were prepared in accordance with the USP monograph, using the USP Vardenafil hydrochloride reference standard and Vardenafil hydrochloride system suitability reference standard (containing 99% Vardenafil hydrochloride and 1% 7-Methylvardenafil). Vardenafil hydrochloride is a PDE-5 inhibitor and is the generic version of the brand name drug Levitra.
USP Vardenafil Hydrochloride Assay and Organic Impurities on Gemini 5 µm C18 and Gemini 5 µm NX-C18 (AN-1014)
This application note for the LC-UV assay and organic impurities for Vardenafil hydrochloride drug substance is based on the official USP monograph which calls for an L1 (C18) 5 µm, 250 x 3.0 mm column under gradient conditions for both assay and organic impurities. The mobile phase, standard solution, and system suitability solution for the assay and organic impurities were prepared in accordance with the USP monograph, using the USP Vardenafil hydrochloride reference standard and Vardenafil hydrochloride system suitability reference standard (containing 99% Vardenafil hydrochloride and 1% 7-Methylvardenafil). Vardenafil hydrochloride is a PDE-5 inhibitor and is the generic version of the brand name drug Levitra.
Document Type:
Technical Notes
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Separation Modes:
Reversed Phase
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