ICH Q3D Drug Product Elemental Risk Assessment: The Use of An Elemental Impurities Excipients Database

Torres, Susana; Boetzel, Ruth; Gatimu, Enid; Gomes, Diego Zulkiewicz; King, Fiona; Kocks, Grace; Jones, Richard C.; Day, C. Andrew; Lewen, Nancy; Harris, Laurence J.; Teasdale, Andrew

doi:10.1016/j.xphs.2021.10.012

Cited by 4 publications

(2 citation statements)

References 2 publications

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“…Since the International Conference on Harmonization (ICH) Q3D guideline came into effect in December 2017, the risk assessment of elemental impurities in drug products has caught the attention of both drug regulatory agencies and pharmaceutical manufacturers in various countries. 1 The reason for the new guideline is that the stability of the drug could be affected by the elemental impurities based on the high catalytic activities of the elemental impurities. 2,3 More importantly, drug products containing the elemental impurities could lead to serious health consequences if used for a long duration.…”

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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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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“…A review of the current literature shows that it is a very rare topic [4,5]. Studies including EI in herbal medicinal products available in pharmacies are dynamically developed by the group conducted by Jurowski et al [6][7][8][9].…”

Section: Introductionmentioning

confidence: 99%

The Toxicological Risk Assessment (TRA) of Total Chromium Impurities in Menthae piperitae tinctura (Mentha x piperita L., folium) Available in Polish Pharmacies Including Regulatory Approaches with Special Emphasis of Cr Speciation and Genotoxicity

Jurowski

Krośniak

2022

Biol Trace Elem Res

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Chromium is pharmacologically active and is not an essential element but is still very intriguing and demanding from the point of view of toxicological risk assessment. Especially as an elemental impurity in final pharmaceuticals. The aim of this article is toxicological risk assessment (TRA) of total Cr impurities in Menthae piperitae tinctura (Mentha x piperita L., folium) available in Polish pharmacies including triple approach. Obtained raw/basal results shows that impurities of total Cr impurities were present in all investigated pharmaceutical with Mentha x piperita L., folium. but at a relatively low level (in the range: 0.39–2.14 µg/L). The regulatory strategy based on the ICH Q3D (R1) elemental impurities guidelines confirms that all the requirements of the analyzed products meet the European Medicine Agency (EMA) requirements. Obtained results obtained show that the estimated maximum daily exposure to Cr (ng/day) are variable between the samples (0.521–3.792 ng/day), but at a relatively low level (< 4.0 ng/day).The final step confirms the safety of analyzed pharmaceuticals, because the comparison of the estimated results with the oral PDE value for Cr in final drugs suggested by the ICH Q3D guideline (10,700 µg/day) show that all the products are below this value. The approach based on the margin of exposure (MoE) for children and adults also confirms the safety of all the products with Mentha x piperita L., (in all cases MoE > > 10 000). It can be concluded that all the samples analyzed should not represent any health hazard to patients due to Cr impurities. To our knowledge, this is the first study about application of comprehensive TRA of total Cr impurities in phytopharmaceuticals with Mentha x piperita L., folium available in European pharmacies. Additionally, we confirm the safety of Cr impurities by applying triple regulatory strategy without the application of an expansive and demanding HPLC-ICP-MS technique for Cr speciation.

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Nitrosamines crisis in pharmaceuticals − Insights on toxicological implications, root causes and risk assessment: A systematic review

Vikram,

Kumar,

Kumar

et al. 2024

Journal of Pharmaceutical Analysis

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ICH Q3D Drug Product Elemental Risk Assessment: The Use of An Elemental Impurities Excipients Database

Cited by 4 publications

References 2 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

The Toxicological Risk Assessment (TRA) of Total Chromium Impurities in Menthae piperitae tinctura (Mentha x piperita L., folium) Available in Polish Pharmacies Including Regulatory Approaches with Special Emphasis of Cr Speciation and Genotoxicity

Nitrosamines crisis in pharmaceuticals − Insights on toxicological implications, root causes and risk assessment: A systematic review

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