Review of the article „Risk Assesment, Screening and Control Elemental Impurities in Pharmaceutical Drug Products: A Review“, verified by Publons, Web of Science
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The scope of this article is to review and describe the steps involved in risk assessment of elemental impurities in drug products based on the permitted daily exposure limits for the twenty-four (24) elements that are considered as potential elemental impurities. Screening and estimation of elemental impurities in drug substances, excipients and drug products by Inductively Coupled Plasma Mass Spectrometry or Inductively Coupled Plasma Optical Emission Spectrometry and their controls involved as referred in the general chapters <232> & <233> of the United States Pharmacopoeia, Q3D guideline for Elemental Impurities as per International Conference on Harmonization and Q3D Elemental Impurities: guidance for Industry as per U. S., Food and Drug Administration US-FDA.
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Current Pharmaceutical Analysis, 2019, 1/BMS-CPA-2018-274-14Collections
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Mašinski fakultetTY - JOUR AU - Jovanović, Tamara PY - 2019 UR - https://machinery.mas.bg.ac.rs/handle/123456789/6038 AB - The scope of this article is to review and describe the steps involved in risk assessment of elemental impurities in drug products based on the permitted daily exposure limits for the twenty-four (24) elements that are considered as potential elemental impurities. Screening and estimation of elemental impurities in drug substances, excipients and drug products by Inductively Coupled Plasma Mass Spectrometry or Inductively Coupled Plasma Optical Emission Spectrometry and their controls involved as referred in the general chapters <232> & <233> of the United States Pharmacopoeia, Q3D guideline for Elemental Impurities as per International Conference on Harmonization and Q3D Elemental Impurities: guidance for Industry as per U. S., Food and Drug Administration US-FDA. T2 - Current Pharmaceutical Analysis T1 - Review of the article „Risk Assesment, Screening and Control Elemental Impurities in Pharmaceutical Drug Products: A Review“, verified by Publons, Web of Science EP - 14 SP - 1/BMS-CPA-2018-274 UR - https://hdl.handle.net/21.15107/rcub_machinery_6038 ER -
@article{ author = "Jovanović, Tamara", year = "2019", abstract = "The scope of this article is to review and describe the steps involved in risk assessment of elemental impurities in drug products based on the permitted daily exposure limits for the twenty-four (24) elements that are considered as potential elemental impurities. Screening and estimation of elemental impurities in drug substances, excipients and drug products by Inductively Coupled Plasma Mass Spectrometry or Inductively Coupled Plasma Optical Emission Spectrometry and their controls involved as referred in the general chapters <232> & <233> of the United States Pharmacopoeia, Q3D guideline for Elemental Impurities as per International Conference on Harmonization and Q3D Elemental Impurities: guidance for Industry as per U. S., Food and Drug Administration US-FDA.", journal = "Current Pharmaceutical Analysis", title = "Review of the article „Risk Assesment, Screening and Control Elemental Impurities in Pharmaceutical Drug Products: A Review“, verified by Publons, Web of Science", pages = "14-1/BMS-CPA-2018-274", url = "https://hdl.handle.net/21.15107/rcub_machinery_6038" }
Jovanović, T.. (2019). Review of the article „Risk Assesment, Screening and Control Elemental Impurities in Pharmaceutical Drug Products: A Review“, verified by Publons, Web of Science. in Current Pharmaceutical Analysis, 1/BMS-CPA-2018-274-14. https://hdl.handle.net/21.15107/rcub_machinery_6038
Jovanović T. Review of the article „Risk Assesment, Screening and Control Elemental Impurities in Pharmaceutical Drug Products: A Review“, verified by Publons, Web of Science. in Current Pharmaceutical Analysis. 2019;:1/BMS-CPA-2018-274-14. https://hdl.handle.net/21.15107/rcub_machinery_6038 .
Jovanović, Tamara, "Review of the article „Risk Assesment, Screening and Control Elemental Impurities in Pharmaceutical Drug Products: A Review“, verified by Publons, Web of Science" in Current Pharmaceutical Analysis (2019):1/BMS-CPA-2018-274-14, https://hdl.handle.net/21.15107/rcub_machinery_6038 .