Diethylene Glycol & Ethylene Glycol Statement on Colorcon Products

Diethylene Glycol & Ethylene Glycol Statement on Colorcon Products
Updated on Sep 4, 2025 Published on Feb 27, 2024 2 minute(s) read

Diethylene Glycol & Ethylene Glycol Statement for Colorcon Products
Colorcon dispersion products are non-compendial excipient mixtures. These products are
designed with ingredients that meet appropriate regulatory/compendial requirements for intended
uses. The compendial compliances certified by Colorcon for each ingredient used in a Colorcon
product are specified in the product specification.

High-Risk Components
Some Colorcon dispersions may contain "High-Risk Components" as identified in the FDA
Guidance titled: "Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch
Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and
Ethylene Glycol." Listed below are materials used in the manufacture of Colorcon dispersions that
are identified in the Guidance as High-Risk Components.

Colorcon Raw Materials Identified as "High-Risk Components"

Glycerin

Propylene Glycol

Sorbitol Solution

Maltitol Solution

Polyethyiene Glycol 300

Polyethlene Glycol 400

As per FDA recommendations, Colorcon performs the USP Identification B Limit of Diethylene
Glycol and Ethylene Glycol test on every container of incoming Glycerin (Glycerol), Propylene
Glycol & Polyethylene Glycol with a Molecular Weight < 1000 and USP Identification C limit of
Diethylene Glycol and Ethylene Glycol test on every container of incoming Sorbitol Solution &
Maltitol Solution to ensure compliance with the limits of NMT 0.10% each for diethylene glycol
and ethylene glycol. Colorcon complies with both compendial and regulatory Guidance related to
DEG & EG for materials where such a limit is applicable. Colorcon includes the specification for the
ingredients used in our dispersion products in the product specifications. Although Colorcon does
not provide a statement related to the absence of DEG & EG in Colorcon products, the product
specification can be used as evidence of compliance to compendial specifications as indicated
including DEG & EG specifications where applicable.

Polyethylene Glycol (PEG)
Colorcon is not considering Polyethylene Glycol (PEG) with a molecular weight >1000 a high-risk
component which would require each container of material tested for DEG & EG. We have made
this determination based on where the DEG & EG test falls within the monograph. The testing for
DEG & EG of Glycerin, Propylene Glycol, Polyethylene Glycol <1000 molecular weight, Sorbitol
Solution & Maltitol Solution are within the identification sections for their respective USP/NF
monographs. The testing for DEG & EG within the PEG and PEG 3350 monographs is within the
impurities section of their respective USP/NF monographs. DEG & EG are impurities from the PEG
and does not lend itself to economic adulteration like other materials such as Glycerin. Colorcon's
PEG suppliers perform testing on DEG & EG on every lot of material and supply a lot specific
Certificate of Analysis (COA) to Colorcon. The limit for DEG & EG for PEG 400 (with a molecular
weight <1000) is NMT 0.1%. While Colorcon does not perform DEG & EG testing on each lot of PEG >1000 molecular weight, testing is performed on an audit basis. Colorcon uses a multi-
layered raw material risk assessment and supplier approval process to qualify and maintain the status of all raw materials and suppliers used globally. Additional details of Colorcon's Supplier
and Raw Material Qualification can be provided upon request.
 

To determine if a Colorcon dispersion product contains an "High-Risk Component", please consult
the Product Regulatory Datasheet (PRD) for the product. The PRD contains a list of all the
ingredients used in the manufacture of the product. PRDs for Colorcon products can be requested
via our Compliance Request Page.

The information contained in this document is proprietary to Colorcon and may not be used or disseminated inappropriately. The
information contained in this document is not intended as legal advice, and should not be relied upon for that purpose.

Global Headquarters
Colorcon
275 Ruth Road, Harleysville, PA 19438
Tel: [phone]
Fax: [phone]
Copyright© 1996-2025 Colorcon
All trademarks, except where noted, are property of BPSI Holdings LLC

This document is valid at time of distribution. Distributed 06-Nov-2025(UTC).