TRENDING TESTING NEEDS

In light of the recent FDA crackdown on DEG (diethylene glycol) and EG (ethylene glycol) in pharmaceuticals, our role in ensuring the safety and integrity of drug components has never been more vital. Element Midland specializes in detecting impurities and contaminants, including DEG and EG, which have been linked to various health risks globally.

Why Our Testing is Essential

Recent events have highlighted the dangers of DEG and EG contamination across various products. These harmful substances can infiltrate drug products, cough syrups, toothpaste, and more through the use of adulterated glycerin and propylene glycol, and other contaminated materials.

DEG and EG are toxic substances, if undetected, can lead to catastrophic health outcomes, even taken in small amounts as evidenced by recent incidents overseas leading to tragic fatalities. Our testing services are not just a regulatory requirement; they are a crucial safeguard against these life-threatening impurities.

In May 2023, the FDA published a “Guidance for Immediate Implementation” for the Industry titled “Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol.” As per the FDA, “this guidance is intended to alert pharmaceutical manufacturers, compounders, repackers, and suppliers to the potential public health hazard of glycerin and other high-risk drug components contaminated with DEG or EG.”

Element Laboratories offers comprehensive testing, detection, and analysis for the presence of DEG and EG in over-the-counter (OTC) drugs, consumer products, ingredients, raw materials, and other chemical compounds using well-established methods. Trust us to ensure the safety and integrity of your products.

Ready to Ensure Your Products Meet the Highest Safety Standards? 

Speak directly with one of our seasoned scientists to understand how we can protect your products from the unseen risks of contamination.

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Our Expertise and Approach

With over 30 years of experience in characterizing unknowns and impurities, Impact Analytical is at the forefront of detecting and dealing with complex contamination challenges. Our proven methodologies are tailored for specific material types, allowing us to efficiently identify, and trace the source of contaminants like benzene. This is not just about compliance; it’s about ensuring the highest standards of product safety.

Other potential sources of impurities we test for include:

– Process and product related impurities

– Degradation of active pharmaceutical ingredients (APIs) and non-active components

– Oxidized polymer additives

– Unreacted monomers/oligomers

– Extractables/Leachables

Your Assurance of Quality and Safety

In a landscape where regulatory vigilance is intensifying, and the risks of contamination are ever-present, partnering with a laboratory that has a deep understanding of these challenges is critical. Our analytical capabilities extend beyond routine testing, providing a comprehensive safety net against the hidden dangers of benzene contamination.