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The Indian Pharmacopoeia Commission (IPC) has issued an industry update on pharmacopoeial and regulatory resources for identifying ethylene glycol (EG) and diethylene glycol (DEG) in medicines to ensure quality and safety.
DEG is a highly toxic chemical known to cause fatal poisoning in contaminated Coldrif cough syrups linked to child deaths recently in the country.
The Central Drugs Standard Control Organisation (CDSCO) has also directed all drug controllers in the States and Union Territories (UTs) to ensure testing of raw materials and excipients before manufacturing and release of the batch to the market.
IPC is an autonomous Institution of the Union ministry of health and family welfare, Government of India (GoI). It publishes Indian Pharmacopoeia (IP) to safeguard public health by establishing pharmacopoeial standards and providing reference substances that ensure the safety, efficacy, and quality of medicines for use in humans and animals.
The IPC has developed a free toolkit by compiling pharmacopoeial and regulatory resources to address contamination with high levels of DEG and EG associated with liquid oral medicines, particularly in allergy, cold, and cough syrups. This document serves as a comprehensive reference, compiling key general chapters and monographs from the IP, available reference standards, along with relevant international guidance’s. The resources are intended to support excipients and raw material suppliers, drug manufacturers, testing laboratories, and regulatory agencies.
General Chapters and General Monographs in the IP provide foundational principles, standardized test methods, and quality assurance procedures that are applicable across multiple monographs. These chapters serve as essential references for ensuring consistency in analytical testing and manufacturing practices.
In the context of DEG and EG contamination, relevant general chapters have also been introduced to offer validated methods and quality control frameworks that help manufacturers detect impurities, assess excipient integrity, and maintain compliance with pharmacopoeial standards. By implementing these chapters effectively, stakeholders can strengthen control over high-risk excipients and safeguard the quality and safety of liquid oral formulations.
The chapter includes General Chapter {2.4.13} Gas Chromatography - Analytical procedure for performing gas chromatography and General Monograph Oral Liquids - Mandatory quality tests to be performed on finished formulations,
Following Excipient Monographs of the IP provide quality specifications for key excipients like glycerin, liquid maltitol, polyethylene glycol 1500, polyethylene glycol 4000, polyethylene glycol 6000, propylene glycol, sorbitol solution (70 per cent) (crystallising) and sorbitol solution (70 per cent) (non-crystallising).
To ensure analytical accuracy and traceability, the relevant IP Reference Standards (IPRS) materials are available through the IPC are diethylene glycol iprs, ethylene glycol IPRS, glycerin (glycerol) IPRS, propylene glycol IPRS, sorbitol IPRS and maltitol (mannitol impurity B) IPRS.
Users can access and purchase IPRS by visiting at https://onlinestore.ipc.gov.in. For any queries related to purchasing IPRS, please write to sales-ipc@gov.in.
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