Screening of Ethylene Glycol and Diethylene Glycol in Medicinal Syrup by GCMS with FASST mode (Part 1 – as per Indonesian BPOM Method)

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User Benefits

・GCMS-QP2020 NX delivers high scan speed capabilities for screening analysis ・Fast Automated Scan/SIM Type (FASST) mode enables consecutive collection of scan and single ion monitoring (SIM) data ・Accurately identify and quantify both EG and DEG in medicinal syrup with a single injection ・Superior reliability and reproducibility of the results obtained

Introduction

Chemical contamination in pharmaceutical products can lead to fatal consequences. In Indonesia, for example, at least 195 deaths among children have been reported relating to ethylene glycol (EG) and diethylene glycol (DEG) contamination in medicinal syrup. In West Africa, Gambia, 70 child deaths were also suspected to be caused by contaminated medicinal syrup. This has caught the attention of the World Health Organization (WHO), hence leading to the issuance of a global alert on this issue.   Propylene glycol, glycerol, and sorbitol are commonly used in medicinal syrup as excipients. Their presence helps improve the solubility of the active ingredients during formulation. They also function as thickeners and sweeteners impacting the taste of the medication. These raw materials are easily contaminated with toxic ethylene glycol (EG) and diethylene glycol (DEG). Over the past few decades, numerous contamination incidents of medicinal syrup with EG and DEG have been reported. Accidental ingestion of EG and DEG may result in abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and kidney injury which leads to death. In this article, we will examine the usage of the Shimadzu GCMS-QP2020 NX to identify and quantify EG and DEG in medicinal syrup. The analysis will be demonstrated using the Fast Automated Scan/SIM Type (FASST) mode, which enables consecutive operation of scan mode and selected ion monitoring (SIM) mode for accurate qualification and quantitation within a single injection.

February 22, 2023 GMT

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