Analysis of Ethylene Glycol and Diethylene Glycol in Glycerin, Propylene Glycol and Sorbitol via GC-FID in Accordance with USP Monographs

User Benefits

- GC-2010 Pro offers advanced capabilities for the detection of EG and DEG contamination in the raw materials (glycerin, propylene glycol and sorbitol) used for manufacturing medicinal syrup. - The configuration proposed in the application news exceeds the requirement specified in the USP monographs. - GC-2010 Pro coupled with the AOC-20i+s Plus autosampler can obtain highly reproducible results using the proposed workflow.

Introduction

Glycerin, propylene glycol (PG) and sorbitol are commonly used as excipients in medicinal syrup during formulation. Their global supply chains are vital to both the pharmaceutical and consumer healthcare industries, as these 3 raw materials are widely used by these industries. Ensuring the safety and quality of these raw materials in the supply chains is a significant challenge to the authorities, as evidenced by some incidents, such as reports of deaths in Indonesia, Gambia and Uzbekistan due to the contamination of ethylene glycol (EG) and diethylene glycol (DEG) in medicinal syrup. Several companies in Indonesia have been implicated for their involvement in the distribution of contaminated raw materials to pharmaceutical companies. To prevent the recurrence of contaminated medicinal syrup from reaching the general public, more stringent multi-level Quality Control (QC) and checks must be in place during the manufacturing of the medicinal syrup. The scope of the QC check must start from the manufacturing of raw materials till the end of the finished products. Following the release of two applications news for the detection of EG and DEG in finished medicinal syrup, this application news is published to show determination of ethylene glycol (EG) and diethylene glyco (DEG) in pharmaceutical raw materials: glycerin, propylene glycol (PG) and sorbitol. This was performed in accordance with the United States Pharmacopoeia (USP) monographs, using a gas chromatograph with flame ionization detector.

January 14, 2024 GMT