Shulga Nikolay A, Gegechkori Vladimir I, Gorpinchenko Natalya V, Smirnov Valery V, Dementyev Sergey P, Ramenskaya Galina V
Department of Pharmaceutical and Toxicological Chemistry named after Arzamastsev, Institute of Pharmacy, Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), 8-2 Trubetskaya Str., 119991 Moscow, Russia.
Pharmaceuticals (Basel). 2025 Jan 7;18(1):59. doi: 10.3390/ph18010059.
: Reference materials are essential for ensuring the accuracy and traceability of measurements in the quality control of medicinal products. This study explores new principles for the preparation of impure materials of active pharmaceutical substances, focusing on 1-(3-benzoylphenyl)ethanone ketoprofen impurity A () as the reference material. : The reference material was synthesised from commercially available acetanilide and benzoyl chloride. The obtained product was purified using preparative chromatography and characterised by infrared spectroscopy (IR), 1H and 13C nuclear magnetic resonance (NMR), and mass spectrometry. The structure was verified using primary research methods to confirm its identity as the target product. : The characterisation confirmed the structure and purity of 1-(3-benzoylphenyl)ethanone, achieving a purity of 99.86%, meeting regulatory documentation requirements. The synthesised product was demonstrated to be identical to the target compound and suitable for use as a reference material. : The developed method provides a robust approach for the preparation and characterisation of 1-(3-benzoylphenyl)ethanone, enabling its use as a certified reference material in the quality control of medicinal products. This approach ensures compliance with regulatory standards and enhances the reliability of pharmaceutical quality assurance practices.
参考物质对于确保药品质量控制中测量的准确性和可追溯性至关重要。本研究探索了活性药物成分杂质材料制备的新原理，重点以1-(3-苯甲酰基苯基)乙酮（酮洛芬杂质A）作为参考物质。：该参考物质由市售的乙酰苯胺和苯甲酰氯合成。所得产物采用制备色谱法纯化，并通过红外光谱（IR）、1H和13C核磁共振（NMR）以及质谱进行表征。使用初步研究方法验证结构，以确认其为目标产物。：表征确认了1-(3-苯甲酰基苯基)乙酮的结构和纯度，纯度达到99.86%，符合监管文件要求。合成产物被证明与目标化合物相同，适用于作为参考物质。：所开发的方法为1-(3-苯甲酰基苯基)乙酮的制备和表征提供了一种可靠的方法，使其能够用作药品质量控制中的认证参考物质。这种方法确保符合监管标准，并提高了药品质量保证实践的可靠性。
