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Q&A
DMSO Grades, Purity, and Regulatory Assurance: Understanding Quality Differentiation and Manufacturing Traceability
Addressing quality and regulatory requirements for pharmaceutical applications.
gChem

Widely used in the pharmaceutical industry for drug discovery, the synthesis of Active Pharmaceutical Ingredients (APIs), and analytical applications, Dimethyl Sulfoxide (DMSO) is a powerful solvent known for its ability to quickly penetrate skin and biological membranes. It’s also an excipient solvent in pharmaceutical drug delivery systems.

The exact purity of DMSO dictates whether it’s suitable and safe across different applications. DMSO is manufactured and classified into specific grades based on its intended use. As such, high-purity DMSO must meet strict regulatory requirements.

gChem is a premier manufacturer and leading innovator of DMSO. The company’s flagship product PROCIPIENT® (Dimethyl Sulfoxide USP, Ph. Eur.) addresses the quality and regulatory requirements, as required by the FDA, for these specific pharmaceutical applications.

Sandra Reid, Senior Director of Sales at gChem shares insight on high-purity DMSO grades, purity, and regulatory assurance, and understanding quality differentiation and manufacturing traceability.

Contract Pharma: How does gChem ensure products consistently meet the necessary specifications for their intended use?

Sandra Reid: At gChem we manufacture multiple grades of Dimethyl Sulfoxide in different manufacturing units, intended for different applications. What does not vary is…

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