Screening of Ethylene Glycol (EG) and Diethylene Glycol (DEG) in Medicinal Syrup

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In the pharmaceutical landscape, ensuring the safety and quality of medicinal syrups is paramount. One of the key concerns in this regard is the potential presence of harmful substances such as Ethylene Glycol (EG) and Diethylene Glycol (DEG). This article delves into the critical role of advanced analytical instruments, such as Shimadzu’s GC and GCMS solutions in the screening process to detect and mitigate the risks associated with EG and DEG contamination.

The pharmaceutical industry is dedicated to ensuring the patients’ safety, which requires the use of cutting-edge technology in quality control processes. Advanced analytical instruments are essential for achieving precision and reliability in quality control testing. In the following sections, we will highlight the importance of accurate screening and the pivotal role played by the Shimadzu’s GCMS in pharmaceutical quality assurance.

Importance of Accurate Screening of EG and DEG

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, diarrhoea, inability to pass urine, headache, altered mental state, and kidney injury which leads to death.

Download Part 1 and Part 2 of Screening of Ethylene Glycol and Diethylene Glycol in Medicinal Syrup by GCMS with FASST mode.

Download Part 1 Here 

Download Part 2 Here 

Analytical Instruments in Screening

In pharmaceutical quality control, the Shimadzu single quadrupole gas chromatograph-mass spectrometer, GCMS-QP2020 NX, emerges as a leading-edge instrument that offers fast and robust screening process for Ethylene Glycol (EG) and Diethylene Glycol (DEG). 

The GCMS-QP2020 NX is an advanced screening analysis tool with high scan-speed capabilities. It features a Fast Automated Scan/SIM Type (FASST) mode that allows for consecutive collection of scan and single ion monitoring (SIM) data. With this powerful tool, it is possible to accurately identify and quantify both EG and DEG in medicinal syrup with just a single injection.

Tune in to our webinar Screening of Ethylene Glycol and Diethylene Glycol in Medicinal Syrup for deeper insights on the topic with Dr Chia Chee Geng, Senior Product Specialist (GC-MS) of Shimadzu Asia Pacific.

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Shimadzu’s End-to-End Workflow Solution For EG/DEG Analysis

Our End-to-End Workflow Solution provides the procedure for accurate determination of EG and DEG in pharmaceutical raw materials (glycerin, propylene glycol, and sorbitol) that describes the recommended Chemical/Reagents and Solutions, Instrument & Consumables, Standard/Sample preparation procedure, Analytical Conditions as per the USP Compendial Monograph and Software operational and Automated Reporting procedure.

The End-to-End Workflow solution can be used with Shimadzu Brevis™ GC coupled with the AOC-30i autosampler and Flame Ionization Detector (FID).

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Introducing Brevis GC

This new space-saving GC delivers uncompromising analytical performance in a modern yet rugged design, easily meeting the analysis needs of laboratories in a range of industries.

Compact without Compromise

The compact Brevis GC-2050, with a 350 mm system width, including an auto-injector (AOC™-30i), makes even more use of lab space. Compared to the flagship Nexis™ GC-2030, the system's width has been reduced by approximately 35 %. At the same time, it is possible to connect additional headspace samplers, a mass spectrometer, and other accessories (available soon), providing the scalability to cover the analytical needs of today's GC/GCMS users.

Built-in Analytical Intelligence

Its intelligent features include:

  • Automatic remote operation
  • Automating the Procedures of Experienced Analysts, Clean Pilot
  • Analysis Starts Immediately under the Optimal Conditions, Automatic Start and Stop Function
  • Protecting Columns
  • Supply Gas Check
 

Best-in-Class Performance

The Brevis GC-2050 provides best-in-class analytical precision. The latest auto-injector, AOC-30i, enables continuous analysis with a high level of precision that cannot be achieved with manual operation. In addition, the flow controller (AFC) with a built-in CPU supports constant linear velocity, constant flow rate, and constant pressure control of carrier gas to achieve outstanding analytical reproducibility with ultra-high speed and ultra-precise control.

Learn More about Brevis GC 

Conclusion

It is extremely crucial to screen for Ethylene Glycol (EG) and Diethylene Glycol (DEG) in medicinal syrups, as their accidental presence can pose serious health risks. With Shimadzu's end-to-end solutions, you can quickly and effectively implement analytical testing to ensure good quality control.

Download our application solutions Part 1 and Part 2 here, and don’t forget to sign up for our on-demand webinar to gain firsthand knowledge about the emerging concern.

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