TERBINAFINE HYDROCHLORIDE

TERBINAFINE HYDROCHLORIDE

Parameter Specification
Product Name Terbinafine Hydrochloride
CAS Number 78628-80-5
Molecular Formula C21H25N·HCl
Molecular Weight 327.9 g/mol
Appearance White to off-white crystalline powder
Assay (HPLC) 99.0% – 101.0%
Solubility Soluble in methanol, ethanol; slightly soluble in water
Package 25 kg fiber drum with double polyethylene liner
Specification 99%

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TERBINAFINE HYDROCHLORIDE Structure

Synonyms: Terbinafine HCl, (E)-N-(6,6-Dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethylamine hydrochloride, Lamisil, Terbinafine hydrochloride

Terbinafine Hydrochloride is a synthetic allylamine antifungal agent, supplied as a white to off-white crystalline powder with a purity of 99% (HPLC). It is the hydrochloride salt form of terbinafine, designed to treat fungal infections of the skin and nails, and is available in both pharmaceutical and technical grades for topical and oral formulations.

With broad-spectrum activity against dermatophytes, this API is a staple in antifungal creams, gels, sprays, and oral tablets. Its mechanism involves inhibiting squalene epoxidase, a key enzyme in ergosterol biosynthesis, leading to fungal cell membrane disruption. The 99% purity grade ensures consistent efficacy and stability in finished dosage forms.

Product Highlights

  • High Purity: 99% assay by HPLC, meeting pharmacopeial standards for pharmaceutical use.
  • Reliable Source: Manufactured under cGMP conditions, with full traceability from raw materials to final batch.
  • Large-scale Supply: Annual production capacity of 50 metric tons, ensuring steady availability for bulk orders.
  • Regulatory Support: DMF and CEP available for regulatory filings in major markets.
  • Custom Packaging: Options for 1 kg to 25 kg packaging to suit R&D and production needs.
  • Fast Turnaround: Stock items ready for immediate dispatch, with lead time of 3-5 business days.

Applications & Formulation Use

  • Topical Antifungal Products: Used in creams, gels, and sprays for treating athlete’s foot, jock itch, and ringworm.
  • Oral Medications: Incorporated into tablets for systemic treatment of nail and skin fungal infections.
  • Veterinary Use: Formulated for treating dermatophytosis in animals.
  • Research: Employed as a reference standard in analytical and pharmacological studies.

Quality Specifications (QC Tests)

Test Item Specification
Identification IR and HPLC retention time match reference standard
Loss on Drying ≤ 0.5%
Residue on Ignition ≤ 0.1%
Heavy Metals ≤ 20 ppm
Organic Impurities Meets EP/USP requirements
Microbial Limits Total aerobic count ≤ 1000 CFU/g; absence of specified pathogens

Bulk Supply & Ordering

  • Packaging: 25 kg fiber drum with double polyethylene liner, or customized packaging.
  • MOQ: 1 kg for sample orders; 25 kg for bulk orders.
  • Lead time: 3-5 business days from order confirmation.
  • Documentation: COA, MSDS, TDS, and regulatory support documents provided upon request.

Frequently Asked Questions

What is the minimum order quantity (MOQ)?

We offer flexible MOQs: 1 kg for sample evaluation and 25 kg for bulk production orders. Larger quantities can be accommodated based on your requirements.

What is the delivery time?

For stock items, delivery is 3-5 business days from order confirmation. We maintain sufficient inventory to ensure prompt dispatch.

Can you provide a COA and samples?

Yes, we provide a batch-specific COA and MSDS with every shipment. Samples are available upon request, typically shipped within 1-2 days.

Contact & Ordering Information

  • Company: LyvBio Co., Ltd.
  • Address: Room 5-0203, Courtyard 205, Lianhu District, Xi’an, Shaanxi, China
  • Email: info@lyvbio.com
  • Phone: +86-29-65816888

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Room,5-0203, Unit 5, Beiyuanmen Street,Xi'an,Shaanxi,China

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