- Raw materials are USP grade according to cGMP and ICH guideline Q7A (a precondition for using a substance as API);
- Aseptic filling according to GMP and DIN EN ISO 13408;
- The primary packaging materials are designed to resist the strong polar solvent DMSO;
- Final tests of confectionery products that exceed USP and EP requirements in, for example, pyrogens, mycoplasma;
- Containers equipped with flip-off-tear-off closures.
closure-DMSO according to Regulation (EC) no: 1907/2006 (REACH) and 1272/2008 (CLP) Date of issue / last revision: 10/2018 SECTION 1: Identification of the substance/mixture and of the company/company 1.1. Product identifier: Name: CryoSure-DMSO, Dimethyl Sulfoxide Cat. No ..: WAK-DMSO-10, WAK-DMSO-50, WAK-DMSO-70 CAS No: MF: C2H6OS EU No: Molecular Weight: AMU 1.2. Relevant identified uses of the substance or mixture and uses advised against: Cryoprotectant for cryopreservation of human cells and tissues for transplantation 1.3. Details of the supplier of the safety data sheet: WAK-Chemie Medical GmbH Siemensstr Steinbach / Ts Tel: Fax: Australian Distributor: Scientific Pty Ltd F1 / 2A Westall Road Clayton, VIC 3168 Phone: / Fax: Web: Emergency phone:
Monday to Friday during office hours, from 9 a.m. to No. 1272 / Label elements according to CE No. 1272/2008: Not a dangerous substance or mixture according to Regulation (EC) No. 1272 / Other hazards: None known Section 3: Composition/information on ingredients 3.1 Substance: Name CAS No. / EC No. concentration value Classification according to Regulation (EC) No. 1272/2008 (CLP) REACH registration No. Dimethylsulfoxide (DMSO) /, 9% Not classified * * A registration number is not available for this substance, as the substance or its use is exempt from registration according to articles 2 and 6. REACH Regulation (EC) n. 1907/2006, the annual tonnage does not require a registration or the registration is planned for a date Has post-registration limit Mixture: This product is a substance.