Evaluation of Risk Factors Associated with Selected Elements in Veterinary Active Pharmaceutical Ingredients Using...

Area of Science:

• Environmental Chemistry
• Analytical Chemistry
• Toxicology

Background:

• Contamination of animal food and medicines with toxic elements is a significant animal and human health concern.
• Essential and non-essential elements can enter the food chain, posing risks through consumption.

Purpose of the Study:

• To quantify essential and non-essential elements in veterinary active pharmaceutical ingredients (V APIs).
• To assess the potential health risks to animals from these elements in V APIs.
• To validate the analytical method used for elemental analysis.

Main Methods:

• Inductively Coupled Plasma Mass Spectrometry (ICP-MS) was employed for elemental analysis.
• Veterinary API samples were categorized into antibiotic, anthelmintic, anticoccidial, and externally used groups.
• Target Hazard Quotient (THQ) and Total Target Hazard Quotient (TTHQ) were calculated to assess risk.

Main Results:

• The antibiotic group exhibited the highest concentrations for most monitored elements.
• All detected elemental concentrations were within the permissible limits set by the United States Pharmacopeia (USP).
• THQ values were below 1 for all samples, indicating no significant animal health risk.

Conclusions:

• The analyzed V APIs do not pose a health risk to animals based on elemental content.
• The ICP-MS method demonstrated good accuracy, linearity (R² > 0.990), and precision (%RSD < 4%).
• Elemental concentrations varied significantly across different veterinary drug groups (p < 0.05), except for Chromium-52 and Iron-54.