Terbinafine HCl

Terbinafine Hydrochloride USP
Broad-spectrum Antifungal API for Dermatological Formulations

Key Specifications:

• CAS: 78628-80-5

• Formula: C₂₁H₂₅N·HCl | M.W.: 327.89

• Purity: ≥99.3% (HPLC)

• Polymorph: Form I (Stable Crystal)

• Water Content: <0.5% (KF)

Critical Quality Attributes:
✓ Related Substances: <0.2% Total
✓ Particle Size: D90 <75μm (Micronized)
✓ Heavy Metals: <10ppm
✓ Microbial Limits: Complies USP <61>

Therapeutic Applications:
• Topical creams/gels (1% w/w)
• Oral tablets (250mg dose)
• Onychomycosis nail solutions
• Veterinary antifungal preparations

Manufacturing Compliance:

• FDA-inspected cGMP facility

• Active USDMF (#23187)

• ICH Q7 compliant synthesis

• REACH Registered

Packaging:
5kg triple-layer aluminum bags
25kg HDPE drums with desiccant

Stability: 36 months at 15-30°C (protected from light)

Competitive Advantages:

1. 99.9% trans-isomer purity

2. Low hygroscopicity (＜0.1% @RH75%)

3. Pre-formulated β-cyclodextrin complexes available

4. Full ICH stability package included