Product Introduction
COA Of Terbinafine Hydrochloride Powder
Key Features & Advantages of Terbinafine Hydrochloride Powder (CAS 78628-80-5)
1. Superior and Targeted Pharmacological Profile
- Fungicidal, Not Fungistatic, Action: Unlike azole antifungals which primarily inhibit growth, Terbinafine Hydrochloride (CAS 78628-80-5) exhibits a potent fungicidal effect against a broad spectrum of dermatophytes at clinical concentrations. This direct killing action is a key advantage, translating to higher mycological eradication rates, faster clinical resolution, and lower probabilities of disease relapse.
2. Strategic Advantages for Pharmaceutical Manufacturers
- Versatile Formulation Foundation: Terbinafine Hydrochloride Powder serves as a reliable API for a wide array of dosage forms. It is successfully formulated into oral tablets, topical creams, gels, solutions, sprays, and innovative nail lacquers, offering manufacturers the flexibility to address diverse market needs.
- Inherent Stability and Quality: Supplied as the hydrochloride salt, Terbinafine Hydrochloride offers excellent chemical and physical stability. Its well-defined crystalline nature ensures consistent performance, reliable processing, and long shelf-life in final products, which are critical factors for global supply chains.
Frequently Asked Questions (FAQ) for Buyers
Q1: What is the guaranteed minimum purity of your Terbinafine Hydrochloride, and what analytical documentation do you provide?
A1: We guarantee a minimum purity of ≥99.0% (by HPLC). Each batch is supplied with a detailed Certificate of Analysis (CoA) that includes results for identity (IR, NMR), assay (HPLC), related substances, residual solvents, heavy metals, and microbiological tests.
Q2: Can you supply material suitable for both oral solid dosage and topical cream formulations?
A2: Yes. Our Terbinafine Hydrochloride Powder meets stringent pharmacopeial standards (USP/EP) suitable for the manufacture of both oral tablets (e.g., 250 mg strength) and topical formulations (e.g., 1% creams and solutions).
Q3: What is your typical lead time, and what package sizes are available?
A3: We offer flexible commercial quantities from kilograms to multi-ton batches. Standard package sizes include 1kg, 5kg, and 25kg fiber drums with double-lined polyethylene bags. Lead times vary by quantity; please contact our sales team for a specific quote and inventory status.
Q4: How does the lipophilicity of Terbinafine Hydrochloride translate to a clinical advantage?
A4: Its high lipophilicity ensures it rapidly distributes and persists for weeks in the skin, nails, and sebum. This allows for shorter treatment durations (e.g., 1 week for ringworm, 12 weeks for nail fungus) compared to older antifungals and contributes to higher sustained cure rates.
Q5: What are the key stability considerations during formulation development?
A5: The API is stable under standard manufacturing conditions. It is slightly soluble in water but freely soluble in common organic solvents like methanol and methylene chloride. For long-term stability of finished products, protect from light and excessive heat. Compatibility studies with intended excipients are always recommended.
Conclusion
Terbinafine Hydrochloride Powder (CAS 78628-80-5) is a mature, reliable, and globally востребованный pharmaceutical ingredient designed for professional buyers seeking consistent quality, regulatory familiarity, and long-term supply stability. Its proven chemical properties, formulation adaptability, and scalable manufacturing make it an essential API in antifungal-related pharmaceutical development and distribution.
For international buyers focused on quality assurance, compliance, and supply reliability, Terbinafine Hydrochloride Powder represents a strategic and dependable choice for both current production and future product pipelines.
TNJONE Products are designed for research and industrial use only. Not intended for clinical or medical purposes.
Hot Tags: terbinafine hydrochloride powder cas 78628-80-5, China terbinafine hydrochloride powder cas 78628-80-5 manufacturers, suppliers, factory, Empagliflozin Powder CAS 864070 44 0, Minoxidil Powder, L carnitine Powder CAS 541 15 1, 6990 06 03 00 00 00, Terbinafine Hydrochloride Powder, Diclofenac sodium Powder
