Forced degradation studies provide valuable insight into the intrinsic stability and efficacy of new drug substances or products, through degradation under conditions more severe than accelerated conditions. These studies not only assess the specificity of stability indicating methods, which measure loss in active pharmaceutical ingredients and resulting increase in degradation products, but also play important roles in formulation and packaging development. In this study, a vaporizing rub and some of its pure components were stressed under acidic, basic, thermal, photolytic, and oxidative conditions. The forced degradation was characterized by gas chromatography-mass spectrometry (GC-MS) to qualify and quantify resulting degradation of cineole, camphor, and menthol, the product’s three active ingredients, as well as the major components of lavender fragrance and eucalyptus oil. Initially, system suitability studies were conducted to assess the resolution and reproducibility of the GC method employed throughout this study. All relevant system suitability requirements for this investigation were met. The vaporizing rub’s active ingredients were relatively stable under basic, thermal, photolytic, and oxidative stressing; however, acidic stressing yielded the greatest degree of degradation at up to 80% of cineole, which is the major component of eucalyptus oil. Additionally, of the three active ingredients, cineole appeared to be the most susceptible to both evaporation and degradation. The results of this analysis provide the information necessary to help better understand degradation pathways and evaluate the nature of primary degradation products.

Forced degradation and GC-MS characterization of natural pharmaceutical ingredients in a vaporizing rub

Macromolecular Chemistry: The Second Century

[Author Benefits](https://scimeetings.acs.org/?utm_source=pubs_content_marketing&utm_medium=website&utm_campaign=0320_MCF_NPI_Launch_Spring_Homepage&ref=pubs_content_marketing)

[How to use SciMeetings](https://storage.googleapis.com/dl.morressier.com/acs/SciMeetings-ACSSpring2020-HowToGuide_M3020-Final.pdf)

[Frequently Asked Questions](https://storage.googleapis.com/dl.morressier.com/acs/SciMtng_ACSNMSp2020_FAQ_M3120_Final.pdf)

ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.