Gaylord Chemical Company’s entire corporate structure is certified to the ISO 9001:2015 Quality System. This Quality System encompasses all service and support functions in addition to our manufacturing facility and product offerings. The manufacturing of Procipient® (Dimethyl Sulfoxide USP, Ph.Eur) is excluded from Gaylord’s ISO 9001:2015 Quality system.
Please contact us to request any of the following certificates:
- ISO 9001:2015 Certificate
- Kosher Parve Certification
- Halal Advisory Group
Procipient® (Dimethyl Sulfoxide USP, Ph. Eur) is manufactured and packaged according to Current Good Manufacturing Practices (cGMP) following ICH Q7 Guidelines for API and meets or exceeds the specifications of both the U.S. Pharmacopoeia and the European Pharmacopoeia.
Procipient®(Dimethyl Sulfoxide USP, Ph.Eur) is supported by a Type II Drug Master File (DMF) with the FDA, a CEP granted by EDQM and a Type I DMF with Health Canada. It is the only DMSO product in the world with this level of regulatory support.
Our Procipient®(Dimethyl Sulfoxide USP, Ph.Eur) manufacturing facility is inspected by the US FDA.
This product is available in 1L glass bottles, 4L glass bottles and 500 lb HDPE drums.
Please use the following link to view or download a copy of the Procipient® (Dimethyl Sulfoxide USP, Ph. Eur) specification sheet.
- Specification: Procipient® (Dimethyl Sulfoxide USP, Ph. Eur)
DMSO is fully compliant with REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulations established in the European Union under Regulation (EC) No 1907/2006. DMSO is not on the list of ‘Substances of Very High Concern’ (SVHC), and is not carcinogenic, mutagenic, toxic for reproduction, or bioaccumulative.
The REACH registration number for DMSO is 01-2119431362-50-0001.
Gaylord Chemical Company utilizes the most up-to-date analytical instrumentation to analyze our products and guarantee that your shipment meets not only our shipping specifications but also your applicable internal quality specifications. Contact Us for more information on our analytical methods..
Gaylord Chemical Company produces chemicals that are often safer alternatives to other chemicals. Dimethyl Sulfoxide is recognized by the International Conference on Harmonization(ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use as a solvent with low toxic potential, Class 3. As such, DMSO is widely used in the pharmaceutical industry.
Another Gaylord Chemical Company product, Dimethyl Sulfide (DMS) has much lower toxicity than other sulfiding agents in oil refineries. DMSO is also odorless in the same use.
The Superfund Amendment and Reauthorization Amendment (SARA) of 1986, often called “Community Right to Know”, has several requirements for industrial facilities to report information about toxic chemicals handled at their facility to the public; this is done through various means and some state and local requirements may be more stringent than the Federal requirements. One important Federal requirement is known as the Toxic Release Inventory (TRI) Report where facilities annually report emissions of certain particularly toxic chemicals.
NONE of the chemicals produced by Gaylord Chemical Company require reporting as a “TRI” compound. It is often an advantage to substitute DMS or DMSO in place of TRI chemicals to make a safer workplace and community.
Gaylord Chemical Company provides extensive product information to assist customers in safely handling and using our chemicals. This includes product information bulletins and Safety Data Sheets (SDS). Gaylord Chemical Company participated in the High Production Volume (HPV) Challenge Program. We did cooperate with the EPA to voluntarily gather data needed to understand and characterize the potential hazards of chemicals produced in the largest quantities.
This information includes physical-chemical properties data, information on the environmental fate of our products and eco-toxicological and toxicological data. The data is being provided to the public after review by EPA and other interested parties. Gaylord and other cooperating producers have sponsored expensive testing to provide data needed to fill the gaps in the information.