VitiPure O 80 Superior
VitiPure O 80 Superior is a non-ionic solubilizer and emulsifying agent for human and veterinary pharmaceutical markets. It is manufactured by ethoxylating sorbitan mono-oleate in a molar ratio of 1:20. VitiPure O 80 Superior is then purified with a patented process to reduce residual impurities yielding a transparent almost colorless oily liquid. Typically used in sensitive formulations 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.
Product Information
- Lower residual impurities compared with standard grade VitiPure O 80
- Nearlycolorless solubilizer, and gives no color shade to final formulation
- Improves stability of finished formulation with sensitive API compared to standard grade of VitiPure O 80
- Steel packaging with nitrogen purging assures lower levels of peroxides during storage of product
- Vegetable sourced (no animal sources)
- Low endotoxin grade suitable for sensitive applications
- Control of TAMC, TYMC, objectionable bacteria
- Control of elemental impurities as per ICH Q3D according, and to the sensitive applications limits
- Polysorbate 80
- Solublizers
- Stabilizer
- Emulsifier
- Nonionic surfactant
- Wetting Agent
- Plasticizers
VitiPure O 80 Superior is a nonionic solubilizer, emulsifying agent, and stabilizer used in sensitive applications where the highest purity of Polysorbate 80 is required to improve the stability and color of end formulations.
Typically used in sensitive formulations with APIs such as: Docetaxel, Filgrastim, Leuprolide acetate, Fosaprepitant dimeglumine, Medroxyprogesterone acetate, Adalimumab, Cabazitaxel, Triamcinolone acetonide, Amiodarone hydrochloride, Rituximab, Erythropoietin alpha human recombinant, Darbepoetin alfa recombinant, Etoposide, immunoglobulin g human plasma-derived, Anidulafungin, Immunoglobulin human, mycophenolate mofetil hydrochloride, peginterferon alfa-2b etc.
Polysorbate 80 (USP), Polysorbate 80 (Ph. Eur.)
IPEC GMP Pharma Grade
India
Clariant India Limited; Telangana 502313, India
15kg / 1kg steel drum with in-liner; Sample size 0.25kg
24 months