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POLYOXYL 35 CASTOR OIL

VitiPure CO 35 Superior

VitiPure CO 35 Superior is a non-ionic solubilizer and emulsifying agent for human and veterinary pharmaceutical markets. It is manufactured by ethoxylating castor oil in a molar ratio of 1:35. VitiPure CO 35 Superior is then purified with a patented process to reduce residual impurities yielding transparent almost colorless oily liquid which forms clear solutions in water. Typically used in sensitive applications where final formulations need to be colorless, or the API is sensitive to residual impurities. And where the end formulation needs to have low microbial load with low endotoxins.

Benefits
  • Low residual impurities such as water, catalyst, and free fatty acids
  • Soluble in most organic solvents used in pharmaceutical formulations
  • Nearly colorless solubilizer, and gives no color shade to final formulation
  • Improves stability of finished formulation with sensitive APIs compared with equivalent standard grade of VitiPure CO 35
  • Steel packaging with nitrogen purging assures low levels of peroxides forming during storage of product
  • Increases bioavailability when used in SEDDS
  • Low Endotoxin grade suitable for sensitive applications
  • Control of TAMC, TYMC, objectionable bacteria
  • Control of elemental impurities as per ICH Q3D according to the sensitive applications limits
Product details
Chemical Name
  • Polyoxyl 35 Castor Oil
Product Function
  • Solublizers
  • Emulsifier
  • Nonionic surfactant
Applications

VitiPure® CO 35 Superior is a nonionic solubilizer and emulsifying agent used in sensitive applications where the highest purity of an excipient is required to improve the stability and color of end formulations. Typically used in sensitive formulations with APIs such as: Paclitaxel, Phytomenadione, Valrubicin, Ciclosporin, Ixabepilone, Plitidespin, Teniposide, and Utidelone.

Generic Name

Polyoxyl 35 Castor Oil (USP), Macrogolglycerol Ricinoleate (Ph. Eur.)

Grade

IPEC GMP Pharma Grade

Country of Origin

India

Manufacturer address

Clariant India Limited; Telangana 502313, India

Packaging size

25kg steel drum with in-liner; Sample size 0.25kg

Retest period

24 months

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VitiPure CO 35 Superior

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