VitiPure™ O 80 LEX G
VitiPure™ O 80 LEX G is a non-ionic, hydrophilic emulsifying, solubilizing and suspending agent used widely in various biopharmaceutical formulations. VitiPure™ O 80 LEX G has a broad working pH range and offers good skin tolerance. The LEX grade represents Low Endotoxins & Low bioburden grade product especially suitable for customers using it in parenteral application.
Product Information
· Includes microbiology specification for
o Endotoxin: max. 1 IU/g
o TAMC: max. 50 cfu/g
o TYMC: max. 10 cfu/g
o Salmonella: absent
o Staphylococcus aureus: absent
o Escherichia coli: absent
o Pseudomonas aeruginosa: absent
· Surpass the current international pharmacopoeia requirements
· Specified and risk assessed for the use as non-sterile excipients in parenteral applications.
- Polysorbate 80
Crystallization Inhibitor, Emulsifying Agent, Gelling Agent, Lubricant, Protein Stabilizer, Solubilizing Agent, Surfactant, and Suspending and/or Viscosity-Increasing Agent.
Germany
Amber liquid
USP-NF: Polysorbate 80
Ph. Eur.: Polysorbate 80
· Complies with all specification requirements of the current version of Ph. Eur. “Polysorbate 80” and USP-NF “Polysorbate 80”
· 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