VitiPure L 20 Superior
VitiPure™ L 20 Superior is a non-ionic solubilizer and emulsifying agent for human and veterinary pharmaceutical markets. It is manufactured by ethoxylating sorbitan mono-Laurate in a molar ratio of 1:20. VitiPure™ L 20 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.
Informations sur le produit
- Lower residual impurities compared with standard grade VitiPure™ L 20
- Nearly colorless solubilizer, and gives no color shade to final formulation
- Improves stability of finished formulation with sensitive API compared to standard grade of VitiPure™ L 20
- 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 20
- Emulsifier
- Stabilizer
- Solublizers
VitiPure™ L 20 Superior is a nonionic solubilizer, emulsifying agent, and stabilizer used in parenteral applications where the highest purity of Polysorbate 20 is required to improve the stability and color of end formulations. It is commonly used into human vaccines, veterinary medicines, biologics such as blood plasma fractionation and small volume parenteral.
Typically used in sensitive formulations with APIs such as: Bevacizumab, Pegfilgrastim, Trastuzumab, Paliperidone palmitate, Doxercalciferol, Denosumab, Epoetin Alfa, Follitropin Alfa, Ranibizumab, Risankizumab, Somatropin, Dexamethasone, neomycin sulphate etc.
Transparent almost colorless liquid
Polysorbate 20 (USP), Polysorbate 20 (Ph. Eur.)
- IPEC GMP Pharma Grade
- EP / USP
India
15kg / 1kg steel drum with in-liner; Sample size 0.25kg
- Transparent colorless liquid
- Stringent Specifications for Microbial Load
- Endotoxin: max. 1 IU/ml
- TAMC: max. 50 cfu/g
- TYMC: max. 10 cfu/g
- Salmonella: absent
- Staphylococcus aureus: absent
- Escherichia coli: absent
- Pseudomonas aeruginosa: absent
- Tighter specification for residual catalyst impurities, peroxides, elemental impurities, fatty acids and water content
