Elemental impurities testing refers to trace heavy metal elements that are present in drugs such as lead and arsenic which can be a massive toxicological concern, resulting in adverse effects on human health if they exceed certain levels. Elemental impurities can generate through raw materials, packaging materials, and equipment during the manufacturing process.
The testing process involves sample preparation, digestion, and analysis:

  • Sample preparation includes the selection of appropriate samples and homogenizing them to ensure representative sampling.
  • Digestion involves the extraction of metal impurities through acid digestion.
  • The analysis is done using the appropriate analytical technique to recognize the elemental impurities present.

The significance of elemental impurity testing in the pharmaceutical industry cannot be overstated. The USP parameters (USP General Chapters 232 and “Elemental Impurities—Limits” and <233> “Elemental Impurities—Procedures”) provide guidelines, such as reference standards, sample preparation, analysis, and data evaluation for the elemental impurities testing for any drug product.

At PLS Analytical, we bring you products ensuring maximum efficacy in accordance with regulatory compliance

We strictly follow the ICH guidelines for the control of elemental impurities in drug products. This requires quantifying and identifying 24 elemental impurities present in drugs, such as arsenic, cadmium, lead, etc. This ensures that each product manufactured at our laboratories is safe and checks all the supervisory requirements.

Advantages Of Elemental Impurities Testing

Elemental impurity testing has several advantages that contribute to ensuring the safety and efficacy of drug products:

  • Regulatory bodies including FDA, ICH, and USP parameters require the identification and quantification of elemental impurities to assure the safety and efficacy of drug products.
  • This analysis enables manufacturers to optimize their manufacturing methods and minimize the presence of impurities in the final product.
  • Certain elements like lead and arsenic can be harmful to human health. Elemental impurity testing improves patient safety.
  • Elemental impurity testing techniques such as ICP-MS and AAS are highly sensitive, allowing better results and reducing the cost of drug testing.

In conclusion, elemental impurity analysis can optimize the manufacturing process and improve quality control, given the samples are analyzed for elemental impurities using validated analytical procedures.

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