VitiPure™ HCO 40 LEX G
VitiPure™ HCO 40 LEX G is versatile non-ionic emulsifying and solubilizing agent enhancing the solubility and bioavailability of hydrophobic APIs and fat-soluble vitamins. VitiPure™ HCO 40 G is obtained by reacting 40 moles of ethylene oxide with hydrogenated castor oil. The LEX grade represents Low Endotoxins & Low bioburden grade product especially suitable for customers using it in parenteral application.
Product Information
VitiPure™ HCO 40 LEX G provides low microbial load for parenteral applications and supports risk assessment in pharmaceutical and biopharmaceutical manufacturing. It is useful for hydrophobic APIs, vitamins and formulations requiring low endotoxin quality.
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.
- Polyoxyl 40 hydrogenated castor oil
Emulsifying Agent, Lubricant, and Solubilizing Agent.
Germany
White to yellowish paste at 20 °C
USP-NF: Polyoxyl 40 Hydrogenated Castor Oil
Ph. Eur.: Macrogolglycerol Hydroxystearate
· Complies with all specification requirements of the current version of Ph. Eur. “Macrogolglycerol Hydroxystearate with 40 molecules of ethylene oxide (nominal value)” and USP-NF “Polyoxyl 40 Hydrogenated Castor Oil”
· Manufactured according to IPEC GMP (Excipients)
· Halal certificate
· Product has been risk assessed for use as a non-sterile excipient in parenteral applications; microbiological and endotoxin testing is performed on every batch