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Amorolfine hydrochloride is used to treat superficial fungal infections of the skin and mucous membranes.
Amorolfine hydrochloride has significant broad-spectrum antifungal activity against medically important fungi, and has dual bactericidal and bacteriostatic activities. Amorolfine hydrochloride not only inhibits the growth of fungi, but also has a very bactericidal function, and its bactericidal ability mainly depends on the concentration of amerofen and the time of contact with bacteria, and the effect of sterilization can also be achieved with a lower concentration for a longer time.
Items | Specifications | Results |
Appearance | White powder | Complies |
Loss on drying | ≤0.5% | 0.17% |
Heavy Metal | ≤10ppm | <10ppm |
Residual solvent:Ethanol | ≤5000ppm | 88ppm |
Assay | ≥99.0% | 99.62% |
Conclusion | The product conforms to the above specifications. | |
| Product parameters | |
| Cas number: | 78613-38-4 |
| Appearance: | White powder |
| Purity: | 99%min |
| Package details: | 100g/foil bag; 1kg/foil bag |
| Brand: | Fortunachem |
Uses:
Amorolfine hydrochloride (CAS 78613-38-4; free base CAS 67467-83-6) is a morpholine-derivative topical antifungal API — the first member of the phenylpropyl-morpholine class, chemically distinct from azoles, allylamines and polyenes. Marketed under brand names such as Loceryl, Curanail, Locetar and Odenil.
| Item | Detail |
|---|---|
| Name | Amorolfine hydrochloride |
| CAS No. | 78613-38-4 |
| Molecular formula | C₂₁H₃₅NO·HCl |
| Molecular weight | 353.97–353.98 |
| Appearance | White to off-white crystalline powder |
| Melting point | ~206–208 °C |
| Solubility | Ethanol ~71 mg/mL; DMSO ~28 mg/mL; water ~9 mg/mL |
| Drug class | Topical antifungal / sterol biosynthesis inhibitor |
| ATC category | D01AE16 (topical antimycotics) |
Mechanism of action: inhibits fungal Δ14-sterol reductase and Δ7–Δ8-isomerase, depleting ergosterol and causing accumulation of ignosterol/atypical sterols. This disrupts cell membrane and organelle structure and increases chitin deposition — producing fungicidal (not merely fungistatic) activity. It also shows sporicidal activity against dermatophyte microconidia and chlamydospores.
Antifungal spectrum: dermatophytes (Trichophyton rubrum, T. mentagrophytes, Microsporum, Epidermophyton), yeasts (Candida albicans and other Candida spp., Malassezia, Cryptococcus), moulds (Scopulariopsis, Alternaria, Hendersonula) and dimorphic fungi. Low sensitivity: Aspergillus, Fusarium, Mucorales. Not active against bacteria.
Key pharmacokinetic advantage: penetrates and diffuses through the nail plate into the nail bed, with long retention in the stratum corneum and negligible systemic absorption (plasma levels remain below detection even after ≥1 year of use). It is ineffective when given orally for systemic mycoses.
Main Uses
1. Finished Pharmaceutical Products (primary market)
5% nail lacquer — onychomycosis (fungal nail infection); applied once or twice weekly; fingernails ~6 months, toenails 9–12 months. This is the flagship indication.
0.25% cream — tinea pedis (athlete's foot), tinea corporis, tinea cruris, cutaneous candidiasis; once daily for 2–6 weeks.
Vaginal formulations (suppositories/solution) — vulvovaginal candidiasis in some markets.
Solutions, sprays and combination products (e.g., with fluconazole or ciclopirox).
2. OTC Dermatological & Foot-Care Products
Classified as an OTC topical antifungal in many countries; used in medicated nail treatments, foot-care kits and anti-fungal nail cosmetics.
3. Veterinary & Agro Applications
Active against fungi pathogenic to animals and plants; explored in veterinary dermatology and plant-protection research.
4. Research & Reference Use
Research reagent for studying ergosterol biosynthesis, fungal membrane biology and phagocytosis/killing assays.
EP/USP reference standards, MIC/MFC testing, in-vitro susceptibility studies.
Sold as research-grade material (≥98–99%) by chemical suppliers.
Key Selling Points
For API buyers / formulators:
Off-patent, clinically proven molecule — decades of clinical use and guideline recognition; ideal for generic and 505(b)(2)/仿制 development without novel-molecule risk.
Unique chemical class — morpholine structure differs from azoles and allylamines, offering a differentiated story and lower cross-resistance concerns.
Fungicidal + sporicidal — kills rather than just inhibits; superior Nail-MFC vs. bifonazole and roughly half the concentration needed vs. ciclopiroxolamine against T. rubrum in vitro.
Once-weekly dosing & nail-substantivity — long retention in keratin supports patient compliance, a strong marketing angle for finished products.
Excellent safety margin — minimal systemic absorption, mainly mild local reactions (burning, itching, erythema); suitable for OTC positioning and for patients who cannot take oral terbinafine/itraconazole.
Broad spectrum incl. non-dermatophyte moulds — covers cases where azoles are weak; useful in combination therapy.
Low dose rate = low API cost per unit — 5% lacquer and 0.25% cream require very little API per pack, supporting attractive COGS.
Multi-format versatility — one API serving nail lacquers, creams, solutions, sprays and vaginal products.
Growing market drivers — aging population, diabetes, rising onychomycosis prevalence and cosmetic demand for nail-health products.
Stable HCl salt, crystalline, well-characterized — amenable to standard GMP synthesis, impurity profiling and analytical control.
Short Marketing Description
Amorolfine hydrochloride (CAS 78613-38-4) is a morpholine-class topical antifungal API with fungicidal and sporicidal activity against dermatophytes, yeasts and moulds. By inhibiting Δ14-sterol reductase and Δ7–Δ8-isomerase, it depletes ergosterol and disrupts fungal cell membranes. Its ability to penetrate and persist in the nail plate enables once- or twice-weekly 5% lacquer therapy for onychomycosis, while 0.25% cream addresses tinea and cutaneous candidiasis. With negligible systemic absorption, a well-established safety profile and off-patent status, it is an attractive choice for generic and OTC dermatological product development.
Compliance Notes for Buyers
Grade matters: research-grade material (RUO) must not be used in human or veterinary medicines; pharmaceutical manufacture requires GMP-grade API with DMF/CEP, full impurity/residual-solvent profiles and stability data.
Regulatory status varies by country (OTC Class A / prescription); verify local registration pathways and pharmacopoeia monographs before filing.
Not effective for systemic/deep mycoses — do not position for oral use.
Contraindicated in hypersensitivity; avoid in pregnancy/lactation and in children due to insufficient data.
HS code typically 2941 series; transport classification may apply — confirm SDS for your shipment.
Also, if you have any other questions, you can contact us
FAQ From Wuhan Fortuna Chemical Co.,Ltd
Q1: Can I get a sample for free ?
A: For small QTY and low value product, we can provide sample for free exclude shipping cost. For high value sample, we will charge the basic sample cost, but we can refund all the cost if customers place order after sample test.
Q2: How to confirm the product quality before placing orders ?
A: Most of our products confirm to international standards like USP/EP/BP/JP/CP. We will provide COA/TDS/MSDS for customers to confirm the specification before placing order.
Q3: What is the payment you accept?
A: For small and low value order, we accept CreditCard, MaterCard,VISA,Western Union and T/T.For large order, we can do T/T and L/C. Any pay on delivery or pay-after are not available for us.
Q4: What is your shipment way ?
A: For less than 100kg gross weight order will ship with courier like FedEx or UPS, we support customers to place courier orders remotely by their account, we will package the goods well and wait for pick up.For more than 100kg goods, we will transport by Air or Sea according to customers' requirement.
Q5: How long is your after-sales service?
A: We accept customer’s quality complaint in three month after customer received the goods. We provide tech.support for all-life if customer place order from our company.
Q6: How do you treat quality complaint ?
A: We support customer to provide our products to any rightful third party testing organization to test our products according to the COA specification, if the test result is confirm with COA, we will take all the loss for customers.
Name:Wuhan Fortuna Chemical Co.,Ltd
Category:Others
Trade Category: Trading Company
Employees: 11 - 50 People
Address: Room 2015, No.2 Building, Kaixin Mansion No.107
Company Information: Wuhan Fortuna Chemical Co.,Ltd established in 2006, is a big integrative chemical enterprise being engaged in Pharmaceutical and Intermediates, Food and Feed additives, Fine chemicals,Biochemical and Reagent, which is the members of Hubei E-commerce Chamber.
Our company has professional persons who major in chemical R&D and sicentific management, supply fine chemical products with high quality and close service, also supply custom-tailored products according to our clients' requirement.
We have a positive and self-motivated management work team with a common philosophy, caring and commitment through teamwork, our team strive to achieve success in delighting our clients and ourselves.
Since Wuhan Fortuna Chemical Co., Ltd founded, we continuously innovate our products and improve our service, sales network. Hence, we initiate the first sale mode on net in China, which is the retail trade of small package bring along wholesale of diversified management modes. Our products are exported widely to South Korea, Vietnam, Australia, Europe and South America, highly recommended by our clients.We insist on the management creed “Market is our compass, Quality is our life, Credit is our soul”. Clients’ trust is our forward power, their satisfaction is our struggling goal.
Wuhan Fortuna Chemical Co.,Ltd is a professional manufacturer which provide Amorolfine Hydrochloride with good quality and best price, welcome to contact us to get COA/TDS/MSDS of Amorolfine Hydrochloride.
1. Guaranteed purity;
2. Large quantity in stock;
3. Largest manufacturer;
4. Best service after shipment with email;
5. High quality & competitive price;
It is an antifungal agent that kills all kinds of fungi that can cause nail infection, Used for finger-to-nail infection caused by fungi.
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