Compliance and Quality Assurance
gChem (Gaylord Chemical) is committed to meeting and exceeding both international and domestic standards for quality, reliability, and compliance. gChem is dedicated to a process of continuous improvement and is always in pursuit of increased efficiency and efficacy of our quality management systems.
gChem manufactures DMSO and supports the production of DMS under the ISO 9001:2015 Quality Management system.
PROCIPIENT® (Dimethyl Sulfoxide USP, PhEur) is manufactured according to Current Good Manufacturing Practices (cGMP) following ICH Q7 guidelines.
gChem is committed to the highest level of Quality and Compliance for its
Products and Services in alignment with international standards
ISO 9001:2015
Certified
cGMP for PROCIPIENT®
per ICH Q7 guidelines
Stringent Quality
Control
Kosher Parve
Certified
Halal Certified
Facility
ISO 9001:2015
gChem’s (Gaylord Chemical’s) entire corporate structure is certified to the ISO 9001:2015 Quality System.
This Quality System encompasses all service and support functions as well as the manufacturing of DMSO at our Tuscaloosa, Alabama, USA production facility.
Please contact us to request gChem’s ISO 9001:2015 for all grades of DMSO.
The manufacturing of PROCIPIENT® (Dimethyl Sulfoxide USP, Ph.Eur) is excluded from gChem’s ISO 9001:2015 Quality system.
Current Good Manufacturing Practice (cGMP)
PROCIPIENT® (Dimethyl Sulfoxide USP, Ph. Eur) is manufactured and packaged according to Current Good Manufacturing Practices (cGMP) following ICH Q7 Guidelines for API production. PROCIPIENT® meets and exceeds 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.
Our PROCIPIENT® (Dimethyl Sulfoxide USP, Ph.Eur) manufacturing facility is inspected by the US FDA with a remarkable inspection histor
Quality Control
gChem (Gaylord Chemical) utilizes the most up-to-date analytical instrumentation to analyze our products and guarantee they meet their required specification.
If you need assistance with DMSO analytical methods, contact us for more information.
Reach Compliance
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.
Additional Certifications
- Kosher Parve Certified
- Halal Certified Facility
Please contact us for more information and to request any of these certificates.