Premium Terbinafine HCL Powder - Professional Antifungal API Manufacturer

We are specialised in manufacturing high-purity Active Pharmaceutical Ingredients with more than 20 years experience in research, development and production. Founded in 2001. We have a state-of-the-art facility of 20,000 square meters, equipped with over 10 modern production lines, and 100,000-level purifying workshops. Our devotion to higher purity standards above 99%, stringent quality control in our SGS-standardized laboratory, and full Certifications such as cGMP, FSSC22000, ISO9001, ISO22000, HALAL, and KOSHER makes us unique to offer this antifungal API. You can expect consistent batch quality, competitive pricing, reliable supply chain management with 3-7 working days delivery and complete technical support for your formulation needs with our Terbinafine HCL Powder.

Product Introduction

Terbinafine HCL is a synthetic allylamine derivative that is a broad-spectrum antifungal active medicinal component that has fungicidal activities . This white to off white crystalline powder exerts its effect thru selective inhibition of fungal squalene epoxidase, as a result blocking ergosterol biosynthesis even as generating risky squalene buildup in fungal mobile membranes. Our ninety nine% specification product has a wonderful lipophilicity, which results in a better diffusion into keratinised tissues, in which it remains for weeks after discontinuation of the remedy. This specific keratinophilia makes it particularly beneficial in the control of onychomycosis, tinea pedis and other recalcitrant dermatophyte infections while the efficacy of standard azole antifungals is restrained.

Third-Party Test Report

Independent verification for quality assurance: We partner with world-class testing laboratories such as SGS and Eurofins to provide independent third-party validation. Comprehensive assessments include: Pesticide residue testing (multi-residue methods) Heavy metal analysis (ICP-MS technology) – lead, arsenic, cadmium and mercury levels Microbiological analysis (total aerobic microbial count and absence of pathogens) Residual solvent analysis (gas chromatography)

Terbinafine hcl

Certificate of Analysis (COA)

Test Item	Specification	Result	Method
Appearance	White to off-white crystalline powder	Conforms	Visual
Assay (HPLC)	≥99.0%	99.5%	HPLC
Related Substances	Total impurities ≤0.3%	0.15%	HPLC
Particle Size (D90)	<20μm (micronized grade)	18μm	Laser Diffraction
Loss on Drying	≤0.5%	0.3%	USP
Residue on Ignition	≤0.1%	0.05%	USP
Heavy Metals	≤10ppm	<5ppm	ICP-MS
Residual Solvents	Meets ICH Q3C	Conforms	GC
Total Aerobic Count	≤1000 cfu/g	<100 cfu/g	USP
Yeast & Mold	≤100 cfu/g	<10 cfu/g	USP

Terbinafine HCL Powder Advantages

Excellent Purity Standards: Our manufacturing process regularly provides test values that are greater than 99.0% with total impurities of less than 0.3% providing maximum therapeutic efficacy and safety profile for your products.

Enhanced Particle Size Distribution: Terbinafine HCL Powder is available in micronised grades with exact control over D90 values to enhance dissolution rates and improve bioavailability, thus overcoming the challenge of low water solubility of this molecule.

Extended Tissue Persistence: Lipophilic and keratinophilic properties of the drug allow long-lasting activity in target tissues such as nails, hair and skin, providing continuous therapeutic benefit much beyond the end of the treatment period.

Terbinafine HCL Powder Application

Oral Solid Dosage Formulations: Often used in production of 250mg tablets for systemic therapy of onychomycosis and severe dermatophyte infections, when micronised grades enhance dissolving and absorption rates.

Topical Pharmaceutical Products: Formulated at 1% concentration in creams, gels, ointments and solutions for treatment of athlete’s foot, jock itch and ringworm where chemical stability prevents hydrolysis in complicated emulsion systems.

Veterinary Antifungal Drugs: Treatment of dermatophytosis in companion animals and cattle by medicated shampoos, topical treatments and feed additives. Efficacy across different delivery matrices.

Production Process

Step 1 - Raw Material Selection and Preparation: We procure pharmaceutical grade precursor materials from approved suppliers and perform incoming quality verification tests.

Step 2 - Synthesis and Chemical Reaction: Our controlled synthesis process involves precise temperature management, pH monitoring, and reaction time optimization under GMP conditions.

Step 3 - Crystallisation and Isolation: The crude product is passed via controlled crystallisation with proven solvent solutions, followed by filtration and washing cycles.

Step 4 - Micronization (If Needed): For grades increased for bioavailability we apply jet milling or other micronization processes under regulated conditions.

Step 5 - Drying and Quality Testing: Product is vacuum dried to desired moisture content and subjected to extensive quality testing including HPLC assay, impurity profiling and physical characterisation.

Step 6 - Packaging and Storage: The final product is packaged in double-layer PE bags in fibre drums within our 100,000-level purification workshop in humidity-controlled settings.

OEM / ODM Support

Customised Formulation Development: With an R&D team of more than 20 experienced professionals, we will work with you to design formulations that are suited to your market demands, whether they be tablets, capsules, topical medicines or speciality delivery systems.

Flexible Specifications: We provide various grades, including standard powder and micronised, with tailored particle size distributions to meet your bioavailability and processing needs.

Private Label & Package Solutions: We offer complete package customisation, from bulk containers to consumer-ready products with your branding, including label design, insert development, and regulatory compliance documents.

Why Choose Us?

Manufacturing Sophistication: Over 23 years of dedicated expertise in pharmaceutical API manufacturing, designated as a national high-tech enterprise and holder of many patented technologies.

Strong Quality Systems: Our standardised SGS laboratory, equipped with HPLC, GC, UV and other sophisticated analytical instruments, carries out rigorous tests at every step of the production process, ensuring batch-to-batch uniformity.

Full Certification Portfolio: Our cGMP, FSSC22000, ISO9001, ISO22000, HALAL, KOSHER, BRC, and ORGANIC certifications reflect our dedication to the highest worldwide pharmaceutical standards.

Packaging

Our Factory

Factory

Our Certifications

Certifications

FAQ

Q: What purity level can you guarantee for the product?

A: We provide pharmaceutical grade product with an assay of minimum 99.0% and usually 99.5% and above. Each batch comes with a full COA detailing purity, impurity profile and conformance to USP/EP monographs.

Q: Do you offer micronised grades for better bioavailability?

A: Yes, we have micronised choices with controlled particle size distributions. Standard standards include D90 <20μm, but we are able to customise the particle sizes to meet your formulation needs and dissolution aims.

Q: What is your minimum order quantity & lead time?

A: Our MOQ is based on grade and specification, from 1kg for samples. Standard manufacture in lots of 25kg. We have a huge inventory and often ship within 3-7 working days for stocked items.

Contact Us

Ready to source premium pharmaceutical-grade Terbinafine HCL Powder for your manufacturing needs? Contact Us today at duke@hongdaherb.com to receive comprehensive product specifications, competitive pricing information, and technical documentation.