Procipient®(Dimethyl Sulfoxide USP, Ph. Eur.) is the only grade of DMSO suitable for Healthcare and Drug Delivery applications. Gaylord Chemical’s USP grade is the only DMSO that is manufactured under cGMP conditions, in compliance with API guidelines (ICH Q7).
Procipient is supported by a Type II Drug Master File (DMF) on file with the FDA, and DMF at Health Canada, and a CEP granted by EDQM. The product is multi-compendial and conforms to both the USP and Ph. Eur. Monographs.
Procipient is the grade of DMSO required in finished pharmaceutical dosage forms. The FDA CDER Inactive Ingredient Database lists applications for this grade. When the highest purity is required, Gaylord is your best resource.
Procipient, an odorless DMSO, is a clear water-white liquid, of low viscosity (2.0 cP @ 25°C) having a density similar to water (1.0955 g / mL @ 25C). It is completely water miscible. DMSO has the ability to significantly depress the freezing point of water, and the high polarity of DMSO is responsible for its almost universal solvent properties.
DMSO is essentially non-toxic by all routes of administration. It is oxidized in the body and resulting metabolic products are excreted in the urine. Its absorption, distribution, metabolism, and elimination (ADME) properties have been studied extensively in both man and animals1.
Pharmaceutical Technology publishes a detailed review of FDA regulated applications which incorporate Dimethyl Sulfoxide USP. This paper provides a precedence of use overview for DMSO excipient and active ingredient applications. PharmTech Procipient
For more information on Procipient Applications, see our Procipient Product Sheet