The FDA has issued Guidance for Industry, Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol, May2023, Revision 1. The contamination of diethylene glycol (DEG) and ethylene glycol (EG) in high-risk drug components has been linked to fatal poisonings of consumers.
To ensure the safety and quality of medicines, the guidance has issued recommendations for preventing DEG and EG contamination. These recommendations include the following:
- All containers of all lots of a high-risk drug components must be tested for DEG and EG as part of the identification testing as directed in the USP-NF monographs for the component.
- High-risk drug components not included in the USP-NF monograph must use a suitable and equivalent procedure to detect and quantify DEG and EG with a safety limit of NMT 0.10%.
A partnership with Alcami’s analytical team can provide support to remain in compliance and to ensure the continued safety of your drug components and drug product. Alcami has experience testing the following drug components for DEG and EG and perform testing without the need for further establishment work:
- Glycerin
- Polyethylene Glycol
- Propylene Glycol
- Sorbitol Solution
- Polyethylene Glycol 3350
- Non-Crystallizing Sorbitol Solution
- Sorbitol Solution
- Polysorbate 20
- Polysorbate 80
- Polyoxyl 15 Hydroxystearate
- Maltitol Solution
Alcami’s years of compendial and validation experience can provide support in development of new methods for other high-risk drug components that do not have a method within the monograph or covered in USP <469>.
FDA Guidance Document (PDF)
Alcami
Alcami : Jan 21, 2020 11:00:00 AM