Application of X-ray fluorescence spectrometry for screening pharmaceutical products for Elemental Impurities according to ICH guideline Q3D

Sauer, Benjamin; Xiao, Youhong; Zoontjes, Michel G. C.; Kroll, Christian

doi:10.1016/j.jpba.2019.113005

Cited by 10 publications

(6 citation statements)

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“…Since the line overlap between Ti and V could affect the assessment of V, we studied 21 elemental impurities except V in contezolid with high concentration of Ti. 13 The RSD of all the six independent results for the screening of 21 elemental impurities in contezolid and 22 elemental impurities in aztreonam was less than 20%. In addition, as shown in Fig.…”

Section: Resultsmentioning

confidence: 87%

“…However, in comparison with EDXRF devices, WDXRF devices are more complex, larger-volume, and more expensive. 13 Recently, the development of EDXRF has benefited from the application of several core techniques, such as the high-performance silicon drift detector, total reflection X-ray fluorescence technique, focusing monochromatic beam technique using X-ray monochromator, and wavelet transforming filter. [14][15][16][17][18][19] Besides, total reflection XRF analysis (TXRF) is a special energy-dispersive X-ray analytical technique extending XRF down to the trace element range.…”

Section: Introductionmentioning

confidence: 99%

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Rapid screening of pharmaceutical products for elemental impurities by a high-resolution portable energy dispersive X-ray fluorescence spectrometer using an efficient fundamental parameter method

Zhu

Teng

Han³

et al. 2023

Analyst

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Section: Resultsmentioning

confidence: 87%

Section: Introductionmentioning

confidence: 99%

Rapid screening of pharmaceutical products for elemental impurities by a high-resolution portable energy dispersive X-ray fluorescence spectrometer using an efficient fundamental parameter method

Zhu

Teng

Han³

et al. 2023

Analyst

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“…Las principales ventajas de esta metodología son: tiempos de análisis muy cortos, bajo costo, corta capacitación para el personal y las calibraciones son estables por largos periodos. En este estudio se llevó a cabo el desarrollo y la validación del método [54]. Este trabajo estableció bases para la utilización de esta técnica en el análisis de impurezas elementales en sustancias activas.…”

Section: (Continúa)unclassified

Impurezas elementales en las sustancias activas: una perspectiva general

Ortiz Lara,

Salvitano Domínguez,

Méndez Campos

et al. 2023

Rev. Colomb. Cienc. Quím. Farm.

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Las sustancias activas deben cumplir con altos requerimientos de calidad, para lograreste objetivo se debe cumplir con varios parámetros tales como un limitado contenidode impurezas. En esta tesitura se pueden mencionar diferentes tipos de impurezastales como orgánicas, inorgánicas, mutagénicas, disolventes residuales e impurezaselementales. La importancia de las impurezas es alta, principalmente porqueson tóxicas y pueden provocar efectos adversos en los pacientes por lo tanto se debenlimitar. Específicamente las impurezas elementales son residuos de elementos metálicosque pueden provenir de varias operaciones en el proceso de fabricación de unasustancia activa. Estos contaminantes se clasifican en la guía ICHQ3D en 4 gruposen función de su toxicidad y su presencia en una sustancia activa se explica por losprocesos de síntesis (materias primas, disolventes, agua) o por desgaste de los equiposproductivos (reactores, centrifugas, secadores, molinos). Para poder determinar lascantidades de estos compuestos los métodos analíticos son parte fundamental yaque deben ser lo suficientemente sensibles y específicos. Aunado a la parte analítica,la evaluación mediante un análisis de riesgo proporciona la información teórica delas potenciales impurezas metálicas presentes en una sustancia activa. Un caso deestudio ejemplifica este apartado. Otro aspecto de suma importancia es el controlde la presencia de las impurezas metálicas en los procesos sintéticos, por lo que teneruna visión general de los métodos de control es de capital importancia con objetoestablecer la estrategia adecuada, este apartado se ejemplifica con un caso reportadoen la literatura. Las tendencias generales de purificación de una sustancia activaproporcionan una perspectiva de los avances en este tema. En esta revisión se incluyeuna breve revisión de los tópicos previamente mencionados.

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“…X-ray fluorescence can be used to quantify practically all elements of interest to pharmaceutical industry, such as heavy metals, within the Maximum Permitted Limits (MPL) as established by the Pharmacopeias assessing the safety of ingestion of each of these elements. More recently, Sauer et al [8] published a new approach focused on the development of a methodology for screening elemental impurities in solid oral pharmaceutical products using EDXRF methodology with very promising results. This work is focused on the study of elemental impurities in pharmaceutical products using EDXRF methodology.…”

Section: Introductionmentioning

confidence: 99%

Validation of the analytical method using the energy dispersive X-ray fluorescence technique (EDXRF) for application in pharmaceutical sciences

et al. 2022

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The determination of impurities in raw materials intended for the production of pharmaceutical products is important to guarantee the quality of the final product, as well as to avoid damage to health. Metallic impurities can exhibit toxic effects even at low concentrations and so permissible levels are defined by the regulatory agencies and pharmacopeias. However, few methods are presented in official compendia in Brazil. In this sense, fast, sensitive, and precise techniques such as the energy dispersive X-ray fluorescence technique (EDXRF) must be evaluated for the analysis of metals in materials for pharmaceutical use. This way, therefore, there is the need to investigate the presence of contaminants and their concentration levels. The major goal of this research work was to validate a method for using the Energy Dispersive X-Ray Fluorescence (EDXRF) technique to identify and quantify the chemical composition of raw materials and pharmaceutical products. The methodology used was based on the selection of a microcrystalline cellulose matrix, which was spiked with two classes of contaminant elements, Class 1 (Cd, Pb, As, Hg) and Class 2A (Co, V, Ni) as defined by ICH guideline Q3D. The qualitative and quantitative analyses were carried out using the EDXRF technique, which proved to be quite effective and met all the validation parameters required in the mandatory official compendia (Resolution of the Collegiate Board (RDC) of Brazilian Health Regulatory Agency (Anvisa) nº 166, July 24, 2017), such as selectivity, linearity, precision, detection limit, quantification limit and robustness. This study showed that EDXRF can be used as a technique for detection and quantification of elemental impurities belonging to Class 1 and Class 2A.

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Application of X-ray fluorescence spectrometry for screening pharmaceutical products for Elemental Impurities according to ICH guideline Q3D

Cited by 10 publications

References 11 publications

Rapid screening of pharmaceutical products for elemental impurities by a high-resolution portable energy dispersive X-ray fluorescence spectrometer using an efficient fundamental parameter method

Rapid screening of pharmaceutical products for elemental impurities by a high-resolution portable energy dispersive X-ray fluorescence spectrometer using an efficient fundamental parameter method

Impurezas elementales en las sustancias activas: una perspectiva general

Validation of the analytical method using the energy dispersive X-ray fluorescence technique (EDXRF) for application in pharmaceutical sciences

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