Volume 99, Issue 2
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645



Substandard antibiotics are thought to be a major threat to public health in developing countries and a cause of antimicrobial resistance. However, assessing quality outside of a laboratory setting, using simple equipment, is challenging. The aim of this study was to validate the use of a portable Fourier transform infrared (FT-IR) spectrometer for the identification of substandard antibiotics. Results are presented for amoxicillin packages from Haiti, Ghana, Sierra Leone, Democratic Republic of Congo, India, Papua New Guinea, and Ethiopia collected over the course of 6 months in 2017, including two field trips with the FT-IR to Ghana and Sierra Leone. Canadian samples were used as a control. Regarding drug quality, of 290 individual capsules of amoxicillin analyzed, 13 were found to be substandard with total active pharmaceutical ingredients (API) lying outside the acceptable range of 90–110%. Of these 13, four were below 80% API. The FT-IR reliably identified these outliers and was found to yield results in good agreement with the established pharmacopeia liquid chromatography protocol. We conclude that the portable FT-IR may be suitable to intercept substandard antibiotics in developing countries where more sophisticated techniques are not readily available.

[open-access] This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


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  1. Hollein L, Kaale E, Mwalwisi YH, Schulze MH, Holzgrabe U, 2016. Routine quality control of medicines in developing countries: analytical challenges, regulatory infrastructures and the prevalence of counterfeit medicines in Tanzania. TrAC-Trends Anal Chem 76: 6070.
    [Google Scholar]
  2. WHO, 2012. Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products. Report A/MSM/1/INF/1. Geneva, Switzerland: World Health Organization.
  3. Interpol, 2014. 2004–2014—Ten years of Combating Pharmaceutical Crime: Review and Prospects, Dublin, Ireland 19–20 November 2014. INTERPOL Background Note. Lyon, France: INTERPOL.
  4. Pezzola A, Sweet CM, 2016. Global pharmaceutical regulation: the challenge of integration for developing states. Glob Health 12: 85.
    [Google Scholar]
  5. Nickerson JW, Attaran A, Westerberg BD, Curtis S, Overton S, Mayer PM, 2016. Fatal bacterial meningitis possibly associated with substandard ceftriaxone—Uganda, 2013. MMWR Morb Mortal Wkly Rep 64: 13751377.
    [Google Scholar]
  6. Mumphansha H, Nickerson JW, Attaran A, Overton S, Curtis S, Mayer PM, Bould MD, 2017. An analysis of substandard propofol detected in use in Zambian anesthesia. Anesth Analg 125: 616619.
    [Google Scholar]
  7. Nayyar GML, Breman JG, Newton PN, Herrington J, 2012. Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa. Lancet Infect Dis 12: 488496.
    [Google Scholar]
  8. Nayyar GML, Breman JG, Herrington JE, 2015. The global pandemic of falsified medicines: laboratory and field innovations and policy perspectives. Am J Trop Med Hyg 92: 27.
    [Google Scholar]
  9. Martino R, Malet-Martino M, Gilard V, Balayssac S, 2010. Counterfeit drugs: analytical techniques for their identification. Anal Bioanal Chem 398: 7792.
    [Google Scholar]
  10. Jamrógiewicz M, 2012. Application of the near-infrared spectroscopy in the pharmaceutical technology. J Pharm Biomed Anal 66: 110.
    [Google Scholar]
  11. Been F, Roggo Y, Degardin K, Esseiva P, Margot P, 2011. Profiling of counterfeit medicines by vibrational spectroscopy. Forensic Sci Int 211: 83100.
    [Google Scholar]
  12. Sacré P-Y, Deconinck E, De Beer T, Courselle P, Vancauwenberghe R, Chiap P, Crommen J, De Beer JO, 2010. Comparison and combination of spectroscopic techniques for the detection of counterfeit medicines. J Pharm Biomed Anal 53: 445453.
    [Google Scholar]
  13. Bate R, Tren R, Hess K, Mooney L, Porter K, 2009. Pilot study comparing technologies to test for substandard drugs in field settings. Afr J Pharm Pharmacol 3: 165170.
    [Google Scholar]
  14. Mbinze JK, Sacré PY, Yemoa A, Mavar Tayey Mbay J, Habyalimana V, Kalenda N, Hubert P, Marini RD, Ziemons E, 2015. Development, validation and comparison of NIR and Raman methods for the identification and assay of poor-quality oral quinine drops. J Pharm Biomed Anal 111: 2127.
    [Google Scholar]
  15. Said MM, Gibbons S, Moffat AC, Zloh M, 2011. Near-infrared spectroscopy (NIRS) and chemometric analysis of Malaysian and UK paracetamol tablets: a spectral database study. Int J Pharm 415: 102109.
    [Google Scholar]
  16. British Pharmacopoeia Commision, 2009. British Pharmacopoeia 2009, Vol. 1. London, United Kingdom: TSO. Available at: http://www.uspbpep.com/ep60/amoxicillin%20trihydrate%200260e.pdf. Accessed October 1, 2017.
  17. Niazi SK, 2009. Handbook of Pharmaceutical Manufacturing Formulations: Uncompressed Solid Products. New York, NY: CRC Press.

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  • Received : 06 Oct 2017
  • Accepted : 20 Mar 2018
  • Published online : 11 Jun 2018
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