Tyloxapol USP (CAS 25301-02-4) is a high-purity, non-ionic surfactant manufactured to USP-grade standards for use in pharmaceutical formulations, laboratory research, and specialty chemical applications. Known for its excellent emulsifying, solubilising, and stabilising properties, it is a preferred excipient in dosage forms where uniform dispersion, stable emulsions, and long-term formulation integrity are required. Its neutral charge and broad compatibility with active ingredients make it suitable for both aqueous and semi-solid systems under regulated manufacturing conditions. Lab Chemicals supplies Tyloxapol USP with Certificate of Analysis and pan-India delivery for pharmaceutical, research, and industrial customers.
Tyloxapol USP is the non-ionic surfactant grade of tyloxapol certified to meet United States Pharmacopoeia (USP) monograph specifications. Its chemical identity is 4-(1,1,3,3-tetramethylbutyl)phenol polymer with formaldehyde and oxirane — a polyethylene oxide adduct of a formaldehyde-phenol condensate. Also known as Triton® WR-1339, it has a long track record in pharmaceutical and laboratory applications as a stable, low-toxicity surfactant.
Tyloxapol’s polymeric structure features hydrophobic tetramethylbutylphenol units alternating with hydrophilic polyethylene oxide chains. This amphiphilic architecture allows it to orient at oil-water interfaces, reducing surface tension and enabling the formation and stabilisation of emulsions, micelles, and dispersions. Its molecular weight varies depending on the degree of ethoxylation, which is why USP monograph compliance rather than a fixed MW specification is the appropriate quality standard for pharmaceutical use.
USP grade signifies that the material has been tested against and meets the specifications published in the United States Pharmacopoeia monograph for Tyloxapol. This includes tests for appearance, identification, viscosity, water content, and heavy metals the full analytical profile required for use as a pharmaceutical excipient. Formulators working in cGMP environments, preparing filings for USFDA, CDSCO, or other regulatory authorities, and documenting excipient qualification under ICH Q8/Q9/Q10 frameworks should use USP-grade Tyloxapol to ensure regulatory acceptability.
yloxapol USP reduces interfacial tension between oil and water phases, enabling the formation of stable oil-in-water and water-in-oil emulsions. It improves the solubility of poorly water-soluble active pharmaceutical ingredients (APIs) through micellar solubilisation, increasing apparent solubility by orders of magnitude in some formulation systems. This property directly supports improved bioavailability of BCS Class II and IV compounds in oral liquid and injectable formulations.
As a non-ionic surfactant, Tyloxapol carries no charge and therefore its performance is not affected by changes in pH or ionic strength in the formulation medium. This distinguishes it from anionic and cationic surfactants, which can precipitate or lose activity outside narrow pH windows. Tyloxapol maintains its emulsifying and dispersing function across pH 2–10, making it suitable for both acidic oral liquids and near-neutral parenteral formulations.
Because of its neutral charge, Tyloxapol does not form ionic complexes with charged APIs, excipients, or preservatives a common source of compatibility failure with ionic surfactants. It is compatible with proteins, peptides, polysaccharides, and many small-molecule APIs. This broad compatibility makes it particularly useful in biological formulations, ophthalmic preparations, and complex multi-component systems where surfactant–drug interactions must be minimised.
Tyloxapol USP is widely used in pharmaceutical formulations where effective solubilisation and stable emulsions are required. In pharmaceutical development, it enhances the bioavailability of poorly water-soluble compounds while maintaining formulation stability making it suitable for products manufactured under regulated cGMP conditions. Typical pharmaceutical dosage forms include oral liquid formulations (suspensions, emulsions), injectable preparations where formulation requirements permit, topical creams, ointments and gels, and ophthalmic formulations. Due to its USP-grade certification, materials identified by CAS 25301-02-4 are appropriate for regulatory submissions to domestic and international authorities. When developing formulations, Tyloxapol is often used in combination with co-solvents such as propylene glycol (USP grade) for enhanced solubilisation of poorly soluble APIs in both oral and parenteral systems.
In laboratory environments, Tyloxapol USP is commonly used to support effective wetting and dispersion of chemical substances. Researchers use it in controlled studies where consistency and formulation stability are essential, including analytical chemistry procedures, formulation research and development, and biological and chemical assay preparation. It is particularly valued in cell biology for its role in cell membrane disruption and lipoprotein clearance studies. Its performance remains reliable across varying experimental conditions, supporting accurate and repeatable results. Reference solutions and working standards prepared with Tyloxapol are stored in amber glass containers working standard vials such as amber glass vials with PTFE septa are recommended for long-term reference solution stability.
In cosmetic and personal care formulations, Tyloxapol is used to support stable emulsions and consistent product performance. Formulators rely on it when developing products requiring smooth application and long-term stability. It is applied in creams and lotions for improved emulsion stability, gels and cleansers requiring uniform ingredient dispersion, and formulations where smooth texture and spreadability are essential. Its compatibility with commonly used cosmetic ingredients makes it suitable for a wide range of personal care products, supporting consistent shelf stability and texture throughout the product lifecycle.
In specialty chemical operations, Tyloxapol is selected for its ability to maintain uniformity during complex processing steps. Production teams value its dependable performance in environments exposed to temperature variation and formulation stress. It supports stable blending where precise control over formulation behaviour is required, including promoting consistent dispersion during formulation stages, maintaining emulsion balance in specialised chemical products, and supporting controlled processing conditions without disrupting chemical reactions.
| Parameter | Specification |
| Packaging | Industry-standard containers suitable for pharmaceutical excipient storage |
| Recommended storage temperature | 0–8°C — temperature-sensitive; do not store at room temperature for extended periods |
| Storage conditions | Cool, dry place away from heat, light, and moisture |
| Shelf life | As per batch CoA — typically 24 months from manufacture date under correct storage conditions |
| Handling | Follow standard pharmaceutical excipient handling procedures; wear gloves and goggles |
| Hazard classification | GHS: Eye Irrit.2 (H319), Skin Irrit.2 (H315), STOT SE3 (H336) — consult SDS before use |
| Disposal | Follow local pharmaceutical/chemical waste regulations |
Lab Chemicals has supplied pharmaceutical excipients, analytical reagents, and laboratory chemicals to pharmaceutical manufacturers, formulation development organizations, NABL-accredited laboratories, and research institutions across India for over three decades. We supply Tyloxapol USP with Certificate of Analysis documentation confirming compliance with USP monograph specifications. Our team can advise on grade selection, pack sizes for pilot and commercial scale, and regulatory documentation requirements for USFDA or CDSCO excipient qualification filings. All orders are dispatched with appropriate temperature-controlled packaging to maintain product integrity during transit.
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