Piroctone Olamine is a pyridone derivative and pharmaceutical/cosmetic active ingredient widely used for its antifungal and antimicrobial properties. It is particularly known for its use in topical and personal-care formulations designed for scalp and skin applications. Piroctone Olamine is the ethanolamine salt of Piroctone, which is chemically related to hydroxypyridone antifungal compounds.
Piroctone Olamine is commonly incorporated into formulations such as anti-dandruff shampoos, scalp treatments, lotions, creams and other topical preparations. It is valued for its activity against microorganisms associated with dandruff and certain superficial fungal conditions.
Piroctone Olamine is identified by CAS Number 68890-66-4. Its molecular formula is C₁₆H₃₀N₂O₃, with a molecular weight of approximately 298.43 g/mol. The substance is also known as Piroctone Ethanolamine and Piroctone Olamine.
The ingredient is generally supplied as a white to slightly yellowish crystalline powder. It has limited water solubility compared with its solubility in certain organic solvents and is commonly incorporated into aqueous or surfactant-based formulations using an appropriate formulation process.
Piroctone Olamine is primarily recognized for its antifungal activity and is widely used in scalp-care products. It is especially associated with anti-dandruff formulations because of its activity against Malassezia species, microorganisms commonly associated with dandruff.
Its mechanism is associated with interference with cellular processes in susceptible fungi, including disruption of essential cellular metabolism. This makes Piroctone Olamine useful in topical pharmaceutical, dermatological and cosmetic formulation development.
Piroctone Olamine can be incorporated into various formulation types, including:
The actual permitted concentration and regulatory classification depend on the intended application and target market. For pharmaceutical applications, the applicable regulatory and finished-product requirements should be followed.
Quality control of Piroctone Olamine can include identity, assay, related substances, water content, residue on ignition, pH and other applicable physicochemical tests.
Because Piroctone Olamine is not supported by a current universal USP/IP/BP/Ph. Eur. API monograph that I can reliably verify for all the CMS limits below, specifications should be based on the approved product specification, customer specification or applicable regulatory standard rather than assigning unsupported pharmacopoeial limits.
Piroctone Olamine manufactured for pharmaceutical, dermatological, cosmetic and personal-care applications should undergo appropriate quality testing and batch-to-batch control. Manufacturing controls can include raw-material qualification, process controls, analytical testing and documented batch release.
For commercial requirements, customers can request the applicable Certificate of Analysis (CoA), product specification, technical documentation, quality documentation and regulatory information for Piroctone Olamine.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0–101.5% |
| Loss on Drying | NMT 0.3% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 8.5–10.0 |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 0.5% |
| Melting Point | 130–136°C |