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Tyloxapol 25301-02-4

Tyloxapol 25301-02-4

USP-NF2025, DMF
  • Product Details

Product Information

 

Product name

Tyloxapol

CAS No.

25301-02-4

Molecular Formula

C17H28O3

Molecular Weight

280.41

Quality Standard

USP-NF2025, DMF

 

COA

 

Test Items

Specifications

Results

Character

Viscous, amber liquid, having a slight, aromatic odor. May exhibit a slight turbidity.

Viscous, amber liquid, having a slight, aromatic odor. May exhibit a slight turbidity.

Solubility

Slowly but freely miscible in water,soluble in glacial acetic acid, in beznene, in toluene, in chloroform, in carbon-tetrachloride and carbon disulfide.

Conforms

Refractive index

1.495~1.501(25℃)

1.497

Infrared identification

Infrared absorption spectrophotometry. Meets the requirements.

Conforms

UV Spectrum

Exhibits maximum and minimum at the same wavelengths as RS

Exhibits maximum and minimum at the same wavelengths as RS

Residue on ignition

NMT1.0%

0.04%

Limit of anionic detergents

NMT0.075%

<0.075%

Limit of ethylene oxide

NMT 10μg/g

N.D

Limit of formaldehyde

NMT0.0075%

<0.0075%

Free phenol

No cloudiness or precipitation is observed immediately

Conforms

Absence of cationic detergents

No blue color is observed in the organic solvent layer.

Conforms

Cloud point

Between 92℃ and 97℃

94℃

Water content

NMT 1%

0.05%

Toluene

NMT 100ppm

0.8ppm

pH(5% solution)

4.0~7.0

5.8

Color value

NMT 150

11

Ethylene Oxide

(internal method)

NMT 10ppm

0.1ppm

Bacterial endotoxins

NMT 2EU/mg

Conforms

Microbial limit

TAMC: NMT 103cfu/ml;

<10cfu/ml

TYMC: NMT 102cfu/ml;

<1cfu/ml

E.coli shall not be detected

Conforms

Storage

Reserve in tight containers.

 

Conclusion

Meets all requirements of USP-NF2025 and Customer needs

 

Usage

 Product at a Glance

Tyloxapol (CAS 25301-02-4), also known as Triton WR-1339, is a nonionic polymeric surfactant supplied as a pharmaceutical excipient. It is an oxyethylated tert-octylphenol–formaldehyde condensate used mainly as a solubiliser, emulsifier and wetting agent in ophthalmic and otic formulations and in contact lens care solutions, and as a spreading aid in synthetic pulmonary surfactant preparations. It is a pale yellow to amber clear viscous liquid, soluble in water and in common organic solvents, and has no fixed molecular weight because it is a polymer.


Applications

1. Ophthalmic formulations: solubiliser and emulsifier for poorly water-soluble actives in eye drops; helps keep the solution clear and physically stable.

2. Otic drops: wetting and solubilising aid.

3. Contact lens and orthokeratology (OK lens) care solutions: cleaning, lens wetting and lubricity that reduces lens-to-cornea friction, and removal of protein deposits from the lens surface.

4. Inhalation and pulmonary products: one of the three components of the synthetic lung surfactant Exosurf Neonatal (colfosceril palmitate, cetyl alcohol and tyloxapol), where it promotes rapid spreading and adsorption at the air–alveolar interface; also used as a wetting and dispersing aid in nebulised and aerosol formulations.

5. Preclinical research: as Triton WR-1339 it induces acute hyperlipidaemia in rodents by inhibiting lipoprotein lipase, and is a standard tool in screening lipid-lowering candidates.

6. General formulation work: solubilisation of lipophilic compounds and stabilisation of dispersions in liquid and semi-solid dosage forms.


FAQ / People Also Ask

1. What is Tyloxapol used for in pharmaceuticals?

Tyloxapol is a nonionic surfactant excipient used to solubilise and emulsify poorly water-soluble drugs in eye drops and otic drops, to clean, wet and lubricate contact lenses in care solutions, and to help synthetic pulmonary surfactants spread at the air–alveolar interface. Under the name Triton WR-1339 it is also used to induce hyperlipidaemia in preclinical research.

2. Is Tyloxapol an API or an excipient?

It is a pharmaceutical excipient, not an active pharmaceutical ingredient. It has no therapeutic claim of its own; its value is functional, as a solubiliser, emulsifier, wetting agent and spreading aid. Buyers are normally finished-dose manufacturers, contact lens solution producers and CDMOs.

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