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This is an update of their 365 35% Dimethicone NF Emulsion. The difference is that 366 does not use a surfactant listed on the European Chemicals Agency REACh (Registration, Evaluation, Authorization and Restriction of Chemicals) Authorization List. In contrast, 365 does– polyethylene glycol tert-octylphenyl ether (TritonTM X-100). These silicone-based products are widely used in the lubrication of glass syringe barrels.
Dow Corning currently does not plan to discontinue 365 for those customers who have already qualified it and will continue to use it. But, for customers who decide to use 366, West is well prepared to provide support in qualification through Analytical Lab Services – from filling syringes, to performance evaluation, to evaluation of targeted leachables, and evaluation of interactions with drug product. West has everything needed to design and execute the experiments needed – state-of-the-art facilities [e.g., Inductively Coupled Plasma Mass Spectroscopy (ICP/MS)] and experienced staff with the right expertise.
Simplify the Journey™ is a trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
Dow Corning® is a registered trademark of Dow Corning Corporation.
Triton™ is a trademark of The Dow Chemical Company.