OPTIM ™ Synthetic Glycerine - A preferred choice for pharmaceutical and biotech applications

Manufacturing processes at Dow, particularly reaction and purification steps, are carefully monitored. This contributes to an exceptionally high purity level of more than 99.7% in OPTIM™ Synthetic Glycerine. The principal consistently used and uniform starting materials are produced by Dow. Thus, all ingredients are reliable and known. The result is an exceptional product of high quality, manufactured according to current Good Manufacturing Practices (cGMP) and thus contributing to people’s health.

In contrast, tallow- and vegetable-based glycerines are usually produced as a by-product of oleochemical processes such as biodiesel, soap, fatty acid and fatty alcohol production. Natural glycerines can therefore contain animal fats such as beef tallow, and vegetable oils such as coconut, palm kernel, cottonseed, and soybean, which can lead to inferior product stability and significant impurities.

OPTIM™ Synthetic Glycerine, however, has a proven track record for absence of microbiological impurities and for long-term stability. OPTIM™ Synthetic Glycerine also has exceptional sensory properties, i.e. virtually no odour and a consistently sweet taste.

Dow is one of the world’s largest producer of synthetic glycerine and manufactures OPTIM™ Synthetic Glycerine in its plant in Stade, Germany, according to current Good Manufacturing Practices (cGMP) based on the IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients 2006.

OPTIM™ Synthetic Glycerine is classified by the Food and Drug Administration (FDA) as Generally Recognized As Safe (GRAS) and complies with the compendial specifications in the:
United States Pharmacopeia (USP)
European Pharmacopoeia (EP) 

OPTIM™ Synthetic Glycerine is an approved food additive as per rule E422 in the European Union and meets Kosher and Halal standards. It is shipped from the Stade production plant in accordance with IPEC’s Distribution Practice Guide (GDP) for Pharmaceutical Excipients, 2006. As an added measure of quality feature, Dow performs state-of-the-art UV (Ultraviolet) spectroscopy analyses on OPTIM™ Synthetic Glycerine. The analysis can help detect the presence of impurities that other standard analytical methods would have difficulties to pick up.

Package Solutions

Click on image to enlarge