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      A new process related impurity identification, characterization, development of analytical method by HPLC and method validation for Voriconazole API

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          Abstract

          During the testing of laboratory Voriconazole API batches, one unidentified impurity (IMP-5.312) was detected employing the Pharmeuropa HPLC technique at a level in excess of 0.10%. This IMP-5.312 was synthesized and then characterized as 6-(3-(2,4-difluorophenyl)-3-hydroxy-4-(1H-1,2,4-triazol-1-yl) butan-2-yl)-5-fluoropyrimidin-4-ol by the corresponding spectral information (MS, 1H-NMR, 13C-NMR, and IR). The IMP-5.312 impurity was effectively quantified using an enhanced HPLC based-technique that was developed as well as validated. The approach made use of a Novapak C18 column with an inner diameter of 3.9 mm and a length of 150 mm (4.0 µm) for chromatographic separation. The analysis of IMP-5.312 was made at 45 °C, with a flow rate (isocratic) of 1.0 mL min −1 and a 256 nm detection wavelength. Acetonitrile, methanol, and 0.1% aqueous trifluoro acetate buffer (pH 4.0) were mixed at a ratio of 15:30:55 ( v/v/v) to create the mobile phase for a 20 μL sample injection. The linearity range of 0.25281–1.51690 μg mL −1 had a correlation coefficient more than 0.99942, and the accuracy ranged from 89.3 to 100.3%. It was noted that the established HPLC based-technique was sensitive, specific, and precise. The technique was executed on the current batches of VRC API for IMP-5.312 analysis, and the outcomes were good. For quality control purposes during the manufacturing procedure of VRC, the identification as well as analysis of IMP-5.312 should be helpful. The in silico approach was applied to predict the IMP-5.312 toxicity. The reports indicated that IMP-5.312 in non-mutagenic and categorized as ICH M7 class-5 impurity.

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          Impurity: pharma market and importance

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            Author and article information

            Contributors
            Journal
            1326
            Acta Chromatographica
            AChrom
            Akadémiai Kiadó (Budapest )
            1233-2356
            2083-5736
            26 June 2024
            Affiliations
            [1 ] Department of Chemistry, School of Applied Sciences and Humanities, VFSTR , Vadlamudi, Guntur, Andhra Pradesh, 522213, India
            [2 ] Analytical Research and Development, Innovare Labs Private Limited, Hyderabad, Telangana, 500090, India
            [3 ] Centre for Chemical Sciences and Technology, Institute of Science & Technology, Jawaharlal Nehru Technological University Hyderabad , Kukatpally, Hyderabad, Telangana–500085, India
            Author notes
            [* ]Corresponding author. E-mail: kishore1pvvn@ 123456gmail.com
            Author information
            https://orcid.org/0000-0003-0410-8628
            Article
            10.1556/1326.2024.01233
            c1693fa7-7965-4404-a30e-0552943fa200
            © 2024 The Author(s)

            Open Access statement. This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License ( https://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted use, distribution, and reproduction in any medium for non-commercial purposes, provided the original author and source are credited, a link to the CC License is provided, and changes – if any – are indicated.

            History
            : 19 April 2024
            : 28 May 2024
            Page count
            Figures: 12, Tables: 7, Equations: 1, References: 21, Pages: 13

            Materials properties,Nanomaterials,Chemistry,Nanotechnology,Analytical chemistry,Thin films & surfaces
            HPLC,spectral data,Voriconazole,IMP-5.312 impurity,characterization,method validation,batch samples

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