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TYLOXAPOL

TYLOXAPOL

Classification: API

CAS NO.: 25301-02-4

Molecular Formula: (C14H22O.C2H4O.CH2O)n

DMF: 041031


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Details

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)

TestSpecificationTest 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(*)1.495~1.501USP41
Infrared identificationInfrared absorption spectrophotometry. Meets the requirements.USP41
Residue on ignitionNMT1.0%USP41
Limit of anionic detergentsNMT0.075%USP41
Limit of ethylene oxideNMT 10μg/gUSP41
Limit of formaldehydeNMT0.0075%USP41
Free phenolNo cloudiness or precipitation is observed immediatelyUSP41
Absence of cationic detergentsNo blue color is observed in the organic solvent layer.USP41
Cloud pointBetween 92℃ and 97℃USP41
Water content(*)NMT 1%USP41
Toluene(*)NMT100ppmUSP41
PH(5%solution)4.0~7.0USP41
Bacterial endotoxinsNMT 2EU/mgUSP41
Microbial limitTAMC: NMT 10²cfu/ml;USP41 (2021) / (2022)
TYMC: NMT 10²cfu/ml;USP41 (2021) / (2022)
E. coli shall not be detectedUSP41 (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.


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