SUPER REFINED® POLYSORBATE 80

SUPER REFINED® POLYSORBATE 80 offers the complete solution when formulating parenteral, oral, ophthalmic, biotech and topical pharmaceutical products. Super Refining is Croda’s proprietary chromatographic process that removes polar impurities, such as peroxides, aldehydes and ketones. Removal of these polar impurities eliminates their adverse interaction with Active Pharmaceutical Ingredients (APIs), thereby, enhancing the stability of the drug and/ or vehicle itself. SUPER REFINED® POLYSORBATE 80 is recommended when the highest quality polysorbate 80 is required and especially when formulating with highly sensitive and unstable APIs. Due to its very low color, it provides an analytical clarity advantage compared to other grades of polysorbate 80.
 

Benefits of SUPER REFINED® POLYSORBATE 80 

  • Analytical Clarity – essentially colorless  - APHA  150 max
  • Peroxide value (PV)  - 2.0 meq 02 / Kg max
  • Formaldehyde - 10 ppm max.
  • Residual EO   - 1 ppm max
  • 1,4 dioxane    - 5 ppm max
  • Residual Na and K – 5 ppm max
  • Moisture – 0.2% max
  • LAL  --- 2.0 EU / ml
  • Multi-compendial – NF,EP,JP
  • Decreased cellular irritation
  • Non – animal origin
  • Strict limit for endotoxin levels in the sorbitol starting material
  • Microbial testing performed on each lot of material
  • Packaged under nitrogen in metal containers to prevent PV increase

 
SUPER REFINED® POLYSORBATE 80 is an extremely mild and effective oil-in-water emulsifier and solubilizer with the following general structure

 



 
  • HLB 15.0
  • Excellent oil-in water emulsifier
  • Produces HLB values suitable for either oil in-water or water in-oil systems, when blended with sorbitan esters
  • Solubilizer, emulsifier, stabilizer, wetting and dispersing agent
  • Plasticizer and tablet lubricant
  • Used in Active Pharmaceutical Ingredient(API) production
  • Used in parenteral, ophthalmic, oral and topical dosages
  • Typical use level 1 – 10% as a wetting agent 0.1 - 3%
  • Listed in 21CFR 172.846 for use as a multi purpose food additive
  • Cited in 21 CFR 172.840 for use in vitamin mineral supplements


REFERENCES     

  1. Handbook of Pharmaceutical Excipients, Fourth Edition, 2003; American Pharmaceutical Association and the Royal Press, Royal Pharmaceutical Society of Great Britain.

 

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SUPER REFINED® POLYSORBATE 80