Syrups containing Non-ionic Surfactants (Polyethylene glycol, Propylene glycol, Glycerin/Glycerol and Sorbitol prone to contain highly Toxic impurities “Ethylene glycol (EG), Diethylene Glycol (DEG
Ethylene glycol & Diethylene glycol (sweet taste) are widely used in Industries in cooling systems as anti-freezing agent, hydraulic brake fluids, some stamp pad inks, ballpoint pens, solvents, synthesis, paints, plastics, films, and cosmetics etc. These two notorious chemicals are highly toxic. On ingestion, these first affect the central nervous system (CNS), then the heart, and finally the kidneys.
Pharmacopoeia [Standards for Drugs Products) of different countries (Indian Pharmacopoeia, British Pharmacopoeia, United State Pharmacopoeia or European Pharmacopoeia] have defined limits of Ethylene glycol (EG) & Diethylene glycol (DEG) in different Surfactants (Polyethylene glycol, Propylene glycol, Glycerin and Sorbitol).
Indian Pharmacopoeia (IP) states clearly, these impurities should be absent like in Polyethylene glycol. Similarly, USP states EG should not be more than 0.062% and the sum of EG & DEG should be lesser than 0.2% in Polyethylene glycol. USP Grade Propylene glycol, Glycerin or Glycerol and Sorbitol should not contain both impurities, individually more than 0.1%. British Pharmacopoeia doesn’t recommend Impurity A (DEG) more than 0.1% and sum of EG & DEG more than 0.5%.
In a nutshell, both impurities should not be present in any surfactant, purported to be used in any orally taken drug product. These must never be used in any injectables, if prone to contain stated impurities, which will be highly lethal. Strict Quality Control and use of highly sensitive techniques (Capillary Column based Gas Chromatograph with FID or MS detector in case of dispute/doubt).
For more details or support, please contact;
Dr. Roopak Kumar
Email: roopak.kumar@itclabs.com
WhatsApp: +91 70870 36598
Website: www.itclabs.com