KLK OLEO has launched an extra pure and stable vegetable glycerine for sensitive applications
Glycerine is a very important excipient especially for sensitive applications in the pharmaceutical industry. Using a novel technology, KLK OLEO has just launched a breakthrough eXtra Pure and Stable Glycerine: ENHEX G 86 XPS which is a solution to maintain drug potency and prevent API degradation.
High-end glycerine for sensitive applications
The ENHEX G 86 XPS glycerine not only complies with the common monographs in terms of critical aldehyde and ketones and extended stability, but offers even more advantages:
- Methanol content of max. 500 ppm of our ENHEX G 86 XPS versus max. 3000 ppm specified in the EP.
- Low levels of Formaldehyde, Glycerinaldehyde, Di- and Hydroxyaceton to avoid contra-productive interactions with the active pharmaceutical ingredient (API). Reactive impurities in pharmaceutical excipients could cause drug product instability, leading to decreased product performance, loss in potency, and/or formation of potentially toxic degradants.
- ENHEX G 86 XPS glycerine is vegetable derived and non-GMO.
Extension of ENHEX G 86 XPS specification according to EP by
- Formaldehyd max. 2 ppm
- Dihydroxyaceton max. 5 ppm
- Glycerinaldehyd max. 5 ppm
- Hydroxyaceton max. 5 ppm