Rapid Identification of Raw Materials Inside Packaging

Rapid Identification of Raw Materials Inside Packaging

 

Rapid Identification of Raw Materials Inside Packaging

Glycerin is a colorless, odorless, viscous liquid with a sweet taste and is widely used in liquid pharmaceutical, cosmetic, and food products. Diethylene glycol (DEG) is also a colorless, viscous liquid with a sweet taste. The analogy stops here. DEG is a glycol with acute toxicity when ingested. In 1995/96, more than 60 children in Haiti died after ingesting a cough syrup containing glycerin tainted with DEG. Following this tragedy, the US FDA published extra guidance on the testing of glycerin for DEG.1 The extra guidance stated that deaths were caused by the ingestion of DEG‑tainted glycerin due to the absence of a full identity test on the glycerin raw material. The FDA also noted that the pharmaceutical manufacturers solely relied on the Certificates of Analysis (CoA) provided by the supplier. The obtained CoA was often a copy on the letterhead of a distributor and not the original glycerin manufacturer CoA. The chain of custody of the document could not be demonstrated because the glycerin raw material changed hands multiple times.

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