Limit test for DEG and EG by GC
The FDA recently published an "Immediately in Effect Guidance for Industry" for testing diethylene glycol (DEG) and ethylene glycol (EG). According to 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”.
Examples of high-risk drug components that may contain DEG or EG:
• Propylene Glycol
• Maltitol Solution
• Hydrogenated Starch Hydrolysate
• Sorbitol Solution
• Polyethylenglykol (only MW <1000),
• Polyethylenglykolmonomethylether 350/550 (only MW <600)
• Polysorbate 20/40/60/80
• Polyoxyl 15 Hydroxystearate
• Polyoxyl 20 Cetostearyl Ether
• Polyoxyl 8 Stearate
• Octoxynol 9
• Nonoxynol 9
Does this guidance appeal to you?
We are pleased to inform you that we have experience in testing DEG or EG in various substances, e.g. the limit test for DEG and EG by GC described in the monograph Glycerol has been established successfully in our laboratory. Contact us and we will be happy to work together on a solution for testing your products.