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Specialized inTerbinafine Hydrochloride CAS 78628-80-5and related product development and production

Chemical Name: Terbinafine Hydrochloride
Synonyms: (E)-N-(6,6-Dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine monohydrochloride
CAS No.: 78628-80-5
Molecular Formula: C21H26ClN
Molecular Weight: 327.89
Appearance: Powder

Samples: Available / Stock: Sufficient
Estimated delivery time: 3-5 days

Terbinafine Hydrochloride (CAS 78628-80-5): A Comprehensive Guide

Table of Contents

1. Basic Information & Physicochemical Properties

Property Value
CAS Number 78628-80-5
Molecular Formula C21H26ClN
Molecular Weight 327.89 g/mol
Melting Point 204-208°C
Solubility Methanol: 50 mg/mL
Water: Slightly soluble
Appearance White to off-white crystalline powder

2. Pharmacological Profile & Mechanism of Action

As an allylamine antifungal, terbinafine hydrochloride inhibits squalene epoxidase, disrupting ergosterol biosynthesis in fungal cell membranes. This dual action mechanism:

  • Depletes ergosterol (essential membrane component)
  • Accumulates squalene (toxic to fungal cells)

Exhibits fungicidal activity against dermatophytes (MIC range: 0.001-0.01 μg/mL) and fungistatic action against Candida species.

3. Approved Clinical Applications

Indication Dosage Form Treatment Duration
Onychomycosis Oral tablets (250 mg) 6-12 weeks
Tinea corporis/cruris Topical cream (1%) 1-2 weeks
Cutaneous candidiasis Topical solution 2-4 weeks
Pityriasis versicolor Topical spray 1 week

4. Dosage Forms & Administration

Available Formulations:

  • Oral tablets: 250 mg
  • Topical preparations: 1% cream/gel/spray

Recommended Dosages:

  • Adults: 250 mg daily (oral)
  • Pediatrics (>2 years): Weight-based dosing
  • Topical: Apply twice daily to affected areas

5. Adverse Reactions & Safety Considerations

Common Reactions (≥1% incidence):

  • Gastrointestinal: Nausea (5.6%), diarrhea (3.7%)
  • Dermatological: Rash (1.3%), pruritus (1.1%)

Serious Adverse Events:

  • Hepatotoxicity (0.01-0.1%)
  • Stevens-Johnson syndrome (<0.01%)
  • Taste disturbance (0.6%)

6. Contraindications & Drug Interactions

Absolute Contraindications:

  • Hypersensitivity to allylamines
  • Chronic/active liver disease
  • Severe renal impairment (CrCl <30 mL/min)

Significant Interactions:

  • CYP2D6 inhibitors: ↑ Terbinafine exposure
  • SSRIs: Potential ↑ QTc interval

7. Storage & Handling Guidelines

  • Store at 20-25°C (68-77°F)
  • Protect from light and moisture
  • Retain in original packaging
  • Discard expired products per local regulations

For clinical inquiries or product specifications:
Email: info@vivalr.com
Tel: (86) 15866781826

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Welcome to visit our factory . As the top chemical manufacturer, we have been striving for product quality, innovation , R&D, and customer service for the past 7 years. In the next 10 years or even longer, we are committed to becoming the most reliable chemical supplier in the world , creating a well-known international brand trusted by customers, with the spirit of “one meter wide, ten thousand meters deep”, we continue to focus on product research and development, continue to focus on customer service, continue to improve the supply chain service system, to create a professional chemical supply service team, to achieve win-win long-term cooperation. Please feel free to contact us if you have any questions.

Drug impurities to intermediates. Years of expertise.

Experience in the synthesis of complex compounds derived from American technology
Focus on the synthesis of difficult compounds
ISO 17034 dual system certification
National high-tech enterprise
5000+ square meters R&D center
A 70+ R&D team led by Chinese and foreign doctors
150 pieces (sets) of R&D equipment, 120+ fume hoods
18 patents

Solid QMS. Offer top-quality products and services.

Through more than ten years of continuous technological innovation and experience accumulation, the team's R&D personnel have established a complete quality management system for CATO, and have successively obtained ISO9001, ISO17034, CNAS and other international certifications.
It has successfully passed on-site inspections from the United States, Australia, Poland, Japan and domestic pharmaceutical company customers and institutions many times, providing high-quality one-stop services for R&D and production of new drugs around the world.

More than 150 sets of equipment to ensure quality.

The emphasis on quality is the basis for our survival and development, and is the most basic requirement for the products and services we provide. CATO has established a scientific, strict and comprehensive quality prevention and assurance system in accordance with international quality standards. Through advanced testing equipment such as GC-MS, chromatograph, nuclear magnetic resonance, scanning electron microscope, and ultraviolet light, quality management is implemented into every aspect of production and operation activities such as raw materials, inventory, production, testing, sales, verification, and training, and "All actions are controlled and traceable" as the work code of conduct for CATO employees.

Over 1000 cases. Synthesize complex compounds.

Currently, CATO serves more than 500 pharmaceutical companies, biotechnology and other companies around the world. Project types cover the entire cycle from pre-clinical to commercialization stages. As of 2020, CATO has delivered more than 1,000 projects in total.
The company has core technologies in key core technology fields such as high-end fluorine chemistry, asymmetric chiral synthesis, glycoside and biological enzyme technology, and continuous microreactors.

About the company

International Standard Chemicals Sell To All Over The World

FAQ

Does it support auditing?

Support, please make an appointment one day in advance. Company address: Room 716, Building 3, Ligao International Garden, No.1222 West Aoti Road, Lixia District, Jinan City, Shandong Province, P.R. China

Whether to provide samples?

Free samples can be provided for low value products, and small packaging specifications can be purchased for high value products.

Delivery time

Under normal circumstances, all items are in stock and will be shipped before 4 o'clock on the same day. Some products are produced to order, depending on the workshop situation and production schedule.

What is the production capacity?

At present, the company's workshop production equipment is mainly based on laboratories and pilot lines, with a maximum daily production capacity of 1.5 tons.

Can additional test indicators be added?

We can provide moisture, UV, IR, HNMR, CNMR, two-dimensional nuclear magnetic spectroscopy, optical rotation detection, elemental analysis, TGA analysis and residue analysis and other related tests to support personalized needs.

Technical direction

In the early stage, our company mainly engaged in drug impurity synthesis and standard product production, with core technologies in chirality, fluorine chemistry, and heterocycles.

Why Chem-iso’s delivery rate is guaranteed to be 99.99%

5000+

square meter R&D center

150+

China(set) of R&D equipment

150+

Fume hood

180+

R&D team

User’evaluation of us

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Michael Cooper

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James Black

" Sincere Chemical team visited our USA factory in the year of 2017. We think highly of cooperation with them. We thanked you for the past excellent orders and best product quality. We also talked about some new products for future orders. We will be still in strategic cooperation in the future and help each other."

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