VitiPure™ CO 35 LEX G
VitiPure™ CO 35 LEX G is a non-ionic solubilizing and emulsifying agent for the human and veterinary pharmaceutical industries. It is made by reacting castor oil with ethylene oxide in a molar ratio of 1:35. It is typically used into formulations such as Topicals (Cream, Hot processing), Solid orals (Hot melt extrusion, Spray drying, Hard shell capsules, Soft shell capsules, Tablets, Instant release), Liquid preparations (Solution). VitiPure™ CO 35 LEX G is a low endotoxin grade non-ionic Solubilizing Agent for parenteral pharmaceutical applications. It combines the functionality of Polyoxyl 35 Castor Oil with stringent microbial control.
Informations sur le produit
- 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.
- Suited for hydrophobic APIs, fat-soluble vitamins and formulations requiring low endotoxin quality.
- Polyoxyl 35 castor oil
Emulsifying Agent, Lubricant, Solubilizing Agent
Germany
Pale yellow to clear liquid depending on the temperature
USP-NF: Polyoxyl 35 Castor Oil
Ph. Eur.: Macrogolglycerol Ricinoleate
· Complies with all specification requirements of the current version of Ph. Eur. “Macrogolglycerol Ricinoleate with 35 molecules of ethylene oxide (nominal value)” and USP-NF “Polyoxyl 35 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