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Research Articles

ICH Q3D based elemental impurities study in liquid pharmaceutical dosage form with high daily intake – comparative analysis by ICP-OES and ICP-MS

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Pages 456-461 | Received 05 Oct 2019, Accepted 23 Jan 2020, Published online: 10 Feb 2020

References

  • Grindstaff J, Schroeder C. Heavy metals testing (USP <231>) revisions: new limits and procedures for elemental impurities in pharmaceuticals and dietary supplements. Drug Dev Deliv. 2011;11(3):67–70.
  • Blake KB. Harmonization of the USP, EP, and JP heavy-metals testing procedures. Pharm Forum. 1995;21(6):1632–1637.
  • Balaram V. Recent advances in the determination of elemental impurities in pharmaceuticals – status, challenges and moving frontiers. TrAC Trends Anal Chem. 2016;80:83–95.
  • Dhuri VG, Dichwalkar SA, Tiwari PN, et al. ICP-MS and ICP-OES – a review. Int J Adv Res Ideas Innov Technol. 2018;4(3):2275–2280.
  • Koons RD. ICP emission spectrometry: a practical guide by Joachim Nölte; Wiley. J Am Chem Soc. 2003;125:16154.
  • Støving C, Jensen H, Gammelgaard B, et al. Development and validation of an ICP-OES method for quantitation of elemental impurities in tablets according to coming US Pharmacopeia chapters. J Pharm Biomed Anal. 2013;84:209–214.
  • Tu Q, Wang T, Antonucci V. High-efficiency sample preparation with dimethylformamide for multi-element determination in pharmaceutical materials by ICP-AES. J Pharm Biomed Anal. 2010;52(2):311–315.
  • Thomas RJ. Chapter 13: ion detectors. In: Measuring elemental impurities in pharmaceuticals: a practical guide. Boca Raton, NY: CRC Press; 2018. p. 137–147.
  • Lewen N, Mathew S, Schenkenberger M, et al. Rapid ICP-MS screen for heavy metals in pharmaceutical compounds. J Pharm Biomed Anal. 2004;35(4):739–752.
  • Wang T, Wu J, Hartman R, et al. A multi-element ICP-MS survey method as an alternative to the heavy metals limit test for pharmaceutical materials. J Pharm Biomed Anal. 2000;23(5):867–890.
  • Barin JS, Mello PA, Mesko MF, et al. Determination of elemental impurities in pharmaceutical products and related matrices by ICP-based methods: a review. Anal Bioanal Chem. 2016;408(17):4547–4566.
  • Huang J, Hu X, Zhang J, et al. The application of inductively coupled plasma mass spectrometry in pharmaceutical and biomedical analysis. J Pharm Biomed Anal. 2006;40(2):227–234.
  • Klencsár B, Sánchez C, Balcaen L, et al. Comparative evaluation of ICP sample introduction systems to be used in the metabolite profiling of chlorine-containing pharmaceuticals via HPLC-ICP-MS. J Pharm Biomed Anal. 2018;153:135–144.
  • Gosar A, Joglekar AA, Patil KD. A case study for risk assessment study of elemental impurities in pharmaceutical drugs by inductively coupled plasma mass spectrometer (ICP-MS). World J Pharm Res. 2019;8(6):897–908.
  • Pohl P, Bielawska-Pohl A, Dzimitrowicz A, et al. Impact and practicability of recently introduced requirements on elemental impurities. TrAC Trends Anal Chem. 2018;101:43–55.
  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH harmonised guideline: guideline for elemental impurities – Q3D(R1). European Medicines Agency; 2019.
  • Maithani M, Raturi R, Sharma P, et al. Elemental impurities in pharmaceutical products adding fuel to the fire. Regul Toxicol Pharmacol. 2019;108:104435.
  • Bennis S, Yachi L, Ouhaddouch H, et al. 5PSQ-112 risk assessment of elemental impurities for manufacturing the drug substance (ICH Q3D). Eur J Hosp Pharm. 2019;26(1):A1–A311.
  • The United States Pharmacopeial Convention. The United States Pharmacopoeia, USP 40-NF 35, Chapter 232: Elemental Impurities- Limits, Revis Bull, Official. 2017;8065–8069.
  • The United States Pharmacopeial Convention. The United States Pharmacopoeia, USP 38-NF 33, Chapter 233: Elemental Impurities- Procedures, Revis Bull, Official. 2015;232–234.
  • Riley CM, Rosanske TW, Riley S. Specification of drug substances and products: development and validation of analytical methods. Amsterdam; Waltham (MA): Elsevier; 2014.
  • European Pharmacopeia 9.0 edition (supplement 9.6). Vol 1. Strasbourg Cedex: Council of Europe, Chapter 2.4.20. Determination of Elemental Impurities, 2018; 5833–5836.
  • Korn MD, Andrade JB, Jesus DS, et al. Separation and preconcentration procedures for the determination of lead using spectrometric techniques: a review. Talanta. 2006;69(1):16–24.
  • Pinheiro FC, Barros AI, Nóbrega AJ. Evaluation of dilute-and-shoot procedure for determination of inorganic impurities in liquid pharmaceutical samples by ICP OES. Microchem J. 2019;146:948–956.
  • Barin JS, Tischer B, Picoloto RS, et al. Determination of toxic elements in tricyclic active pharmaceutical ingredients by ICP-MS: a critical study of digestion methods. J Anal Atom Spectrom. 2014;29(2):352–358.
  • Pinheiro FC, Babos DV, Barros AI, et al. Microwave-assisted digestion using dilute nitric acid solution and investigation of calibration strategies for determination of As, Cd, Hg and Pb in dietary supplements using ICP-MS. J Pharm Biomed Anal. 2019;174:471–478.
  • Pinheiro FC, Barros AI, Nóbrega AJ. Microwave-assisted sample preparation of medicines for determination of elemental impurities in compliance with United States Pharmacopeia: how simple can it be? Anal Chim. 2019;1065:1–11.
  • Shrivastava A, Gupta V. Methods for the determination of limit of detection and limit of quantitation of the analytical methods. Chron Young Sci. 2011;2(1):21.
  • Boumans P. Detection limits and spectral interferences in atomic emission spectrometry. Anal Chem. 1994;66(8):459A–467A.
  • Rajaković LV, Marković DD, Rajaković-Ognjanović VN, et al. Review: the approaches for estimation of limit of detection for ICP-MS trace analysis of arsenic. Talanta. 2012;102:79–87.

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