The Use of Ethylene glycol (EG) and diethylene glycol (DEG) in Pharmaceutical Industry
Ethylene glycol (EG) and diethylene glycol (DEG) are common impurities found in pharmaceutical excipients such as glycerin, propylene glycol, and sorbitol, frequently used by the pharmaceutical industry in medicinal syrup formulation. Gas chromatograph with FID (GC-FID) is the preferred chromatographic system for analyzing these impurities as per USP monographs. The analysis is crucial for ensuring excipient safety by USP for medicinal syrup production, addressing significant public health concerns.
Examples of high-risk drug components that may contain DEG or EG:
- Glycerin
- Propylene Glycol
- Maltitol Solution
- Hydrogenated Starch Hydrolysate
- Sorbitol Solution
- Polyethylenglykol (only MW <1000),
- Diethylenglykolstearate
- 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
Tamilnadu test House offers EG, DEG analysis and we have validated the method in GC-FID in our laboratory. Please contact us