VitiPure™ HS 15 LEX
VitiPure™ HS 15 LEX is a low endotoxin grade polyoxyl 15 hydroxystearate designed as a non-ionic solubilizing and emulsifying agent for parenteral pharmaceutical applications. Produced by reacting 12-hydroxystearic acid (lipophilic moiety) with 15 moles of ethylene oxide. The LEX grade represents Low Endotoxins & Low bioburden grade product especially suitable for customers using it in parenteral application.
Product Information
VitiPure™ HS 15 LEX is primarily used to solubilize poorly water-soluble APIs and can function in parenteral, oral and topical formulations.
Includes microbiology specification for
· Endotoxin: max. 1 IU/g
· TAMC: max. 50 cfu/g
· TYMC: max. 10 cfu/g
· Salmonella: absent
· Staphylococcus aureus: absent
· Escherichia coli: absent
· Pseudomonas aeruginosa: absent
Surpass the current international pharmacopoeia requirements.
Specified and risk assessed for the use as non-sterile excipients in parenteral applications.
- Polyoxyethylene (15) hydroxystearate
Emulsifying Agent, Lubricant, Solubilizing Agent, Surfactant, and Vehicle.
White to yellowish waxy to solid mass
· Complies with all specification requirements of the current version of Ph. Eur. “Macrogol 15 Hydroxystearate” and USP-NF “Polyoxyl 15 Hydroxystearate”
· Manufactured according to IPEC GMP (Excipients)
· Halal certificate
· Product has been specified and risk assessed for the use as non-sterile excipients in parenteral applications; microbiological and endotoxin testing is performed on every batch
USP-NF: Polyoxyl 15 Hydroxystearate
Ph. Eur.: Macrogol 15 Hydroxystearate
Germany