VitiPure™ L 20 LEX G
VitiPure™ L 20 LEX G is a non-ionic, hydrophilic emulsifying, solubilizing and suspending agent. The LEX grade represents Low Endotoxins & Low bioburden grade product especially suitable for customers using it in parenteral application.
Informations sur le produit
VitiPure™ L 20 LEX G supports parenteral applications requiring low microbial load. It can be used as a solubilizing agent and stabilizer where low endotoxin quality and consistent surfactant performance are required.
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.
- Polysorbate 20
Crystallization Inhibitor, Emulsifying Agent, Gelling Agent, Lubricant, Protein Stabilizer, Solubilizing Agent, Surfactant, and Suspending and/or Viscosity-Increasing Agent.
Germany
Yellow to amber liquid
USP-NF: Polysorbate 20; Ph. Eur.: Polysorbate 20
· Complies with all specification requirements of the current version of Ph. Eur. “Polysorbate 20”
· Complies with all specification requirements of USP-NF “Polysorbate 20”
· 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 first drum every batch