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Assessment of Elemental Impurities and Associated Health Risks in Common Active Pharmaceutical Ingredients Using
Adnan M Massadeh1, Waad E Abu Diak2, Yahya R Tahboub2
1Department of Medicinal Chemistry and Pharmacognosy, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, 22110, Jordan. massadeh@just.edu.jo.
Biological Trace Element Research
|July 16, 2026
Summary
This study assessed elemental impurities in Jordanian pharmaceutical ingredients. Most were within safe limits, but lead (Pb) exceeded guidelines in some, and Amoxicillin showed a higher health risk index.
Area of Science:
- Pharmaceutical Analysis
- Environmental Health
- Analytical Chemistry
Background:
- Elemental impurities in pharmaceuticals pose potential health risks.
- Regulatory bodies like ICH and USP set permissible limits for these impurities.
- Assessing these impurities is crucial for drug safety and quality control.
Purpose of the Study:
- To determine the concentration of 15 elemental impurities in active pharmaceutical ingredients (APIs) from Jordanian manufacturers.
- To evaluate the associated health risks of these elemental impurities.
- To validate the analytical method used for impurity quantification.
Main Methods:
- Inductively coupled plasma mass spectrometry (ICP-MS) was employed for elemental analysis.
- 38 API samples from various Jordanian pharmaceutical manufacturers were analyzed.
- Health risks were assessed using the hazard index (HI) established by the US EPA.
Main Results:
- Most elemental impurities were within or below USP and ICH Q3D (R2) permissible limits.
- Lead (208Pb) concentrations exceeded limits in some samples.
- The hazard index was below 1 for most APIs, except for Amoxicillin.
- ICP-MS method validation demonstrated good accuracy, linearity (R2 > 0.996), and recovery (>95%).
- Nickel (60Ni) and Bismuth (209Bi) showed statistically significant differences across medication categories (p < 0.05).
Conclusions:
- While most elemental impurities in Jordanian APIs are within acceptable limits, lead requires attention.
- Amoxicillin samples warrant further investigation due to a higher hazard index.
- The validated ICP-MS method is reliable for elemental impurity analysis in pharmaceuticals.
- This study provides novel data on rarely reported elements and integrates profiling with health risk assessment.
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