Analysis of Ethylene Glycol and Diethylene Glycol in Glycerin, Propylene Glycol and Sorbitol Solutions (Indian Pharmacopoeia Monographs)

User Benefits

- Brevis GC offers advanced capabilities for the detection of EG and DEG contamination in the raw materials (glycerin, propylene glycol, and sorbitol solutions) used for manufacturing medicinal syrup. - Brevis GC coupled with the AOC-30i autosampler can obtain highly reproducible results using the proposed workflow. - The configuration proposed in the application news exceeds the requirement specified in the IP monographs.

Introduction

Ethylene glycol (EG) and diethylene glycol (DEG) are classified as toxic alcohols. These chemicals are colorless, odorless, and water-soluble. There have been multiple incidents involving the deaths of children due to medicinal cough syrups contaminated with these impurities. These impurities often originated from the raw materials (such as glycerin, propylene glycol, and sorbitol solutions) or excipients used in their formulation (1-2). Substandard and falsified raw materials frequently enter the excipient supply chain, causing significant challenges for drug manufacturers and regulatory bodies. The complexity of the global supply chain, which often involves importing raw materials from various countries, worsened this issue. Therefore, it is crucial to frequently test these raw materials upon receipt to prevent the reoccurrence of such incidents and protect public health. This application news demonstrates the use of GC-FID for analyzing EG and DEG contaminants in glycerin, propylene glycol (PG), and sorbitol solutions (70%) (both crystallizing and non-crystallizing) in accordance with the Indian Pharmacopoeia (IP) monographs. Shimadzu’s Brevis GC, featuring a compact design with a width that is approximately 35% smaller than existing GC models, is used in this experiment. This design allows the Brevis GC to occupy less space in the laboratory and to be eco-friendly with reduced power consumption, while maintaining analytical performance and enhancing productivity.

September 18, 2024 GMT