Products – Anmol Chemicals Private Limited
Polysorbate 80 FCC
Abstract
Polysorbate 80 is derived from polyethoxylated sorbitan and oleic acid. The hydrophilic groups in this compound are polyethers also known as polyoxyethylene groups, which are polymers of ethylene oxide.
The full chemical names for polysorbate 80 are: Polyoxyethylene (80) sorbitan monooleate and (x)-sorbitan mono-9-octadecenoate poly(oxy-1,2-ethanediyl).
Use/Application
It is a nonionic surfactant and emulsifier often used in pharmaceuticals and chemical industries.
Identity:
Molecular Formula: C64H124O26
Molecular Weight: 2917 g/mol
EINECS EC Number: 500-019-9
CAS No : 9005-65-6
| Test | Specification……..FCC |
| Characters | It occurs as a yellow to orange colored, oily liquid. |
| Identification
Test(A) Test(B) Test(C) |
(a)Specified Test. The solution is strongly opalescent. (b) Specified Test. The bromine is decolorized (c) Specified test. |
| Solubility | It is very soluble in water, producing a nearly colorless solution, and it is soluble in alcohol, in fixed oils, in ethyl acetate, and in toluene. It is insoluble in mineral oil. |
| Acid Value | Not more than 2 |
| 1,4- Dioxane | Not more than 10mg/kg |
| Hydroxyl Value | Between 65 and 80 |
| Lead | Not more than 2mg/kg |
| Oleic acid | Specified test. Between 22 and 24 g per 100 g of sample. |
| Residue on ignition | Not more than 0.25% |
| Saponification value | Between 45 and 55 |
| Water | Not more than 3% |
| Assay for Oxyethylene Content | Not less than 65.0% and not more than 69.5% of oxyethylene groups, equivalent to between 96.5% and 103.5% of Polysorbate 80, calculated on the anhydrous basis. |
Shelf life, Storage and Packing
It should be stored in a segregated area in a cool and ventilated place away from combustible materials. Keep in a tightly closed container, sealed until ready for use. It is packed in 25kg or 50kg HDPE bags or drums as required.
Other
We Manufacture Bulk Dugs/API, Excipients, pharmaceuticals (IP/BP/USP/NF/PH. EUR./JP), Speciality Chemicals (Pure/AR/ACS), mineral fortifiers (FCC). our manufacturing facility is GLP, GMP (FDA) approved, ISO 9001, ISO 14001, ISO 22000, FSSC 22000, FSSAI, kosher, halal, COPP and WHO-GMP certified.
Good Manufacturing Practice Certified by World Health Organization (WHO-GMP)
Written Confirmation Certification (WC)
Good Manufacturing Practice (EXCiPACT cGMP)
Good Manufacturing Practice (cGMP)
Good Laboratory Practice (GLP)
