CAS NO.: 25301-02-4
Molecular Formula: (C14H22O.C2H4O.CH2O)n
DMF: 041031
Product Characteristics:
Tyloxapol is a non-ionic surfactant, usually appearing as a colorless to pale yellow viscous liquid. It has good emulsifying, dispersing and solubilizing properties.
Technical Data (Executive Standard:USP41)
Test | Specification | Test Method |
【Character】 | Viscous, amber liquid, having a slight, aromatic odor. May exhibit a slight turbidity. | USP41 |
Solubility | Slowly but freely miscible in water, soluble in glacial acetic acid, in benzene, in toluene, in chloroform, in carbon tetrachloride and carbon disulfide. | USP41 |
Refractive index(*) | 1.495~1.501 | USP41 |
Infrared identification | Infrared absorption spectrophotometry. Meets the requirements. | USP41 |
Residue on ignition | NMT1.0% | USP41 |
Limit of anionic detergents | NMT0.075% | USP41 |
Limit of ethylene oxide | NMT 10μg/g | USP41 |
Limit of formaldehyde | NMT0.0075% | USP41 |
Free phenol | No cloudiness or precipitation is observed immediately | USP41 |
Absence of cationic detergents | No blue color is observed in the organic solvent layer. | USP41 |
Cloud point | Between 92℃ and 97℃ | USP41 |
Water content(*) | NMT 1% | USP41 |
Toluene(*) | NMT100ppm | USP41 |
PH(5%solution) | 4.0~7.0 | USP41 |
Bacterial endotoxins | NMT 2EU/mg | USP41 |
Microbial limit | TAMC: NMT 10²cfu/ml; | USP41 (2021) / (2022) |
TYMC: NMT 10²cfu/ml; | USP41 (2021) / (2022) | |
E. coli shall not be detected | USP41 (2021) / (2022) |
Applications:
As an expectorant, it is suitable for patients with viscous sputum that is difficult to cough up, as it can reduce the surface tension of sputum and lower its viscosity. It can also be used as a pharmaceutical excipient, functioning as a solubilizer and bacteriostatic agent, and is applied in contact lens and orthokeratology (OK) lens care solutions, eye drops, ear drops, etc. It is suitable for pharmaceutical preparations such as tobramycin eye drops, tobramycin and dexamethasone eye drops, and cyclosporine eye drops.
Packaging and Storage:
This product is packaged in bottle, 500g per bottle, and can also be customized according to user requirements. It should be sealed and stored in a cool, dry place away from light, with a shelf life of twenty-four months.
Safety Protection:
This product should be kept away from contact with eyes, skin, or clothing. In case of splashing onto the body, immediately rinse with plenty of water.