“We’ve built on our proven track record by supporting the development and production of pharmaceuticals with a broader portfolio of solutions for the industry’s growing technologies, such as the injectables segment."
"With our new excipients, we address the market’s need for low endotoxin and highly purified solubilisers,” comments Vaios Barlas, Global Head of Health Care at Clariant.
Clariant introduces VitiPure LEX 3350 S, VitiPure LEX 4000 S and Polyglykol 1450 S to solve active pharmaceutical ingredient (API) delivery and bioavailability challenges
The VitiPure LEX product line has been designed for customers who require stringent control of the microbial load in their formulations.
These cosolvents have been optimised for sensitive applications, as well as for the safe use with a variety of APIs, including those with low water solubility.
VitiPure LEX 3350 S and VitiPure LEX 4000 S not only surpass the general pharmacopoeia monograph requirements, but they have also been risk-assessed in their production for their use as excipients in parenteral applications.
In addition to the general monograph requirements, specific microbiological aspects have also been certified.
Polyglykol 1450 S is an alternative polyethylene glycol cosolvent specified according to the current USP-NF monograph, which is additionally meeting the monoethylene and diethylene glycol limits recommended by the corresponding FDA guideline on this topic.
Polyglykol 1450 S is produced under IPEC GMP conditions in the form of flakes, which allows easier handling during production. This product surpasses current international pharmacopeia requirements.