Propylene glycol, also known as methyl ethyl ethylene glycol, 1,2-propanediol, or propane-1,2-diol, is a synthetic transparent colorless liquid widely used as an additive or antifreeze in the chemical, food, cosmetic, and pharmaceutical industries. Propylene glycol is an important excipient that increases the solubility and stability of both prescription and over-the-counter drugs. In addition, propylene glycol helps to maintain moisture in certain topical preparations such as drugs and ointments due to its water absorbing ability.

Ethylene glycol and diethylene glycol are toxic to human health and are typically present as impurities in propylene glycol. In response to these toxicity considerations and following the recommendations of the United States Food and Drug Administration (USFDA), the United States Pharmacopeia (USP) revised monograph 4 on propylene glycol in 2010. This monograph specifies the limits of ethylene glycol and diethylene glycol to address toxicity issues, while using propylene glycol as a non active ingredient to meet drug quality standards 4,5. The updated monograph identifies propylene glycol and defines limit tests for ethylene glycol and diethylene glycol. The content of ethylene glycol and diethylene glycol in propylene glycol samples is measured using an internal standard peak response quantitative method using gas chromatography/flame ionization detector (GC-FID).

This application article showcases PerkinElmer GC 2400 ™ The system (with FID) performed quality analysis of propylene glycol based on the updated USP monograph, and demonstrated * * performance, improving separation by 40%.

instrument

The PerkinElmer GC 2400 system, equipped with a capillary split/non split (CAP) injector and a PerkinElmer Elite 624 analytical column, provides a simplified solution for the quality evaluation of propylene glycol. The GC 2400 system is equipped with PerkinElmer AS 2400TM liquid sampler and FID, providing a reliable platform for USP grade propylene glycol analysis to quantify impurities such as ethylene glycol and diethylene glycol.

When connected to the laboratory network, PerkinElmer Simplicity Vision runs on a split touch screen for real-time monitoring and status checks, optimizing time and improving laboratory efficiency.