Ketoconazole

Description

1. Product Overview
Ketoconazole is a high-purity, broad-spectrum imidazole antifungal agent, industrially utilized as a key active pharmaceutical ingredient (API) and as a biocidal additive in specialty industrial coatings. Its primary value proposition is delivering reliable fungistatic and fungicidal activity against dermatophytes and yeasts, enabling manufacturers to produce finished formulations with proven therapeutic or preservation efficacy. Strategically, it remains critical for markets requiring cost-effective, non-azole-alternative APIs, particularly in emerging economies and veterinary health sectors.

2. Key Specifications & Technical Characteristics

• Chemical composition: Ketoconazole (USP/EP/BP grade), C₂₆H₂₈Cl₂N₄O₄

• Purity level: ≥ 99.0% (anhydrous basis)

• Physical characteristics: White to off-white crystalline powder; particle size (D90: < 20 µm) for uniform blending; bulk density: 0.45–0.65 g/cm³

• Packaging options: Double LDPE liner inside HDPE drums (25 kg net) or custom multi-ply paper bags

• Shelf life: 36 months when stored in original, tightly closed container under controlled room temperature (15–25°C)

3. Core Industrial Applications

• Pharmaceutical manufacturing (human & veterinary): Oral tablets, topical creams, and shampoos for treating seborrheic dermatitis and systemic fungal infections.

• Industrial biocides: Additive in adhesives, sealants, and non-food-contact polymers to prevent mold colonization on substrates.

• Animal health: Medicated feed premises and topical sprays for companion animals and livestock.

• Performance advantage: Superior heat stability (up to 180°C) compared to miconazole, enabling processing in higher-temperature formulations without degradation.

4. Competitive Advantages
Consistent batch-to-batch purity with full traceability and audited quality management systems (cGMP, ISO 9001:2024). Dedicated supply chain redundancy (dual sourcing of raw intermediates) ensures < 2% annual lead time deviation. Cost-competitive pricing via continuous process optimization (Yield increase of 12% year-over-year). Full regulatory documentation package (DMF, COA, MSDS) provided digitally upon order confirmation.

5. Commercial & Supply Information

• Minimum Order Quantity (MOQ): BULK 20 metric tons (20MT) per shipment

• Loading capacity: 20 MT per 20-foot standard dry container (palletized, 25 kg HDPE drums, 800 drums total)