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Assessment of Extractables and Leachables from Pharmaceutical Packaging: Ink and Adhesive Migration in Selected Maternal Health Drugs in Nigeria

Peter Obinna Okwuego, Omoh Theodore Oshokha

Abstract

Pharmaceutical packaging materials, particularly inks and adhesives used on ampoules and labels, can release hazardous substances that compromise drug safety. This study evaluated extractables and leachables (E&L) in selected maternal health drugs magnesium sulphate, oxytocin, and metronidazole commonly sold in Nigeria. Packaging materials and drug contents were analyzed using Gas Chromatography-Mass Spectrometry (GC-MS), Fourier Transform Infrared Spectroscopy (FTIR), Ultraviolet-Visible Spectrophotometry (UV-Vis), Atomic Absorption Spectrophotometry (AAS), and Energy Dispersive X-ray Fluorescence (ED-XRF). Results revealed significant levels of polycyclic aromatic hydrocarbons (PAHs), including naphthalene (7991.20 mg/L), phenanthrene (1167.80 mg/L), and anthracene (531.80 mg/L), as well as butyl acrylate and acrylic acid in ink and adhesive extracts. Heavy metal analysis detected high concentrations of chromium (3080 mg/L), while lead, cadmium, and nickel were negligible. Although leachables were generally absent or detected only at trace levels in drug contents, compounds such as ethylamine, ethylene glycol, and heptadecane nitrile were identified in metronidazole samples. These findings underscore the potential health risks associated with packaging-derived contaminants, particularly under suboptimal storage conditions. The study highlights the urgent need for regulatory enforcement of standardized packaging materials, mandatory E&L testing, and continuous quality surveillance within the Nigerian pharmaceutical sector to safeguard patient health.

Keywords

Extractables and Leachables (E&L)Pharmaceutical PackagingMaternal Health

References

Mmuo V.E and Okwuego P.O (2024) Spectrophotometric Determination Of Proximate, Vitamin B Complex and Elemental Contents of Pigeon Peas (Cajanus Cajan) Anachem Journal, 15(1), 85-95, DOI:https://doi.org/10.5281/zenodo.14567423 Nkachukwu M. B ,Okwuego P. O ,Ifeakor C. O , Offiah V. O (2025) Spectroscopic Analysis of Leachables and Extractables from Selected Pharmaceutical Packaging: Assessing Ink and Adhesive Migration in Drug Labels and Containers in Nigeria. International Journal of Trend in Scientific Research and Development (IJTSRD) Volume 9 Issue 2. ijtsrd.com e- ISSN: 2456 – 6470 Nwankwo N.V, Chinweuba A.J, Nwadiogbu O.J, Okwuego P.O, Odika I. M. (2025) Pesticide Levels in Two Fish Species from a Section of the Niger River, Anambra State, Nigeria. Asian Journal of Fisheries and Aquatic Research Vol. 27, Issue 4, Page 45-55, no. AJFAR.133708 ISSN: 2582-3760 Ochie O.S., Okonkwo S.I. P. O. Okwuego (2025) Synthesis and Characterization of Nanostructured Sorbents Derived from Rice Husks using FTIR, SEM, TEM and XRD Approaches. International Research Journal of Pure and Applied ChemistryVolume 26, Issue 1, Page 38-48, Article no. IRJPAC.129516ISSN: 2231-3443, NLM ID: 101647669 Okonkwo S.1, Ughanze B.N, Okonkwo C.K, Ezigbo V.O, Okafor, E.C , Okwuego P.O, Okonkwo A.T, Okonkwo V. S.(2025) Determination of the Chemical and Morphological Structure of Liposomes Encapsulating Lycopene Derived from Tomatoes Using FTIR, SEM, TEM, and Ultrasound Imaging Techniques Volume 03 | Issue 04 | Article Id IJPS/250304235 Okorie E.A, Offiah V, O, Oragwu P.I, Okwuego P.O (2025) Assessment of Heavy Metals and Polycyclic Aromatic Hydrocarbons in Soil and Water in Selected Mining Areas of Ebonyi State, Nigeria. Journal of Global Ecology and Enviroment. Doi: 10.56557/jogee/v21i29123 Okwuego P. O (2022) Oil Removal by Structured Natural Sorbents Made from Pumpkin Stem Fibres. COOU Journal of Physical Sciences (6)1 https://cjps.coou.edu.ng/ Okwuego P. O, (2023) Optimization of oil spill cleanup using composites fibres (ES) modified kola nut pod. Adhesive Migration in Selected Drug Products in Nigeria International Journal Of Research And Innovation In Applied Science (IJRIIAS) ISSN NO. 2454-6194 DOI: https://doi.org/10.51584/IJRIASs.10040007 Oragwu I.P, Okolo. A, J, Okwuego P.O, Ntokah. K. .(2024) Characterization of Some Local Clay Minerals and Fabrication into Ceramic Floor-Tiles American Journal of Polymer Science and Technology DOI: 10.11648/j.ajpst Vol. 10. Issue 4 ISSN 2575-5986 Sylvia Ifeyinwa Okonkwo, Benedicta Nonye Ughanze, Emmanuella Chinyere Okafor, Charles Kenechukwu Okonkwo 1, Vera Obiageli Ezigbo, Peter Obinna Okwuego, Adachukwu Theresa Kene-Okonkwo, Valentine Somtochukwu Okonkwo and S.C Okonkwo (2025) Synthesis and characterization of chitosan-stabilized lycopene nanoparticles for prostate cancer therapy: Integrating sonography for enhanced imaging and treatment monitoring, World Journal of Advanced Research and Reviews, 2007-2017 DOI: https://doi.org/10.30574/wjarr.2025.25.3.0822

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