Swapnroop is a pharmaceutical API manufacturer in India offering Terbinafine Hydrochloride API for pharmaceutical manufacturing applications. Terbinafine Hydrochloride is a synthetic allylamine antifungal active pharmaceutical ingredient used in oral and topical antifungal formulations.
Terbinafine Hydrochloride works primarily by inhibiting fungal squalene epoxidase, an enzyme involved in ergosterol biosynthesis. This mechanism disrupts fungal cell membrane formation and contributes to its antifungal activity.
Terbinafine Hydrochloride, commonly abbreviated as Terbinafine HCl, is the hydrochloride salt of terbinafine. It is an allylamine antifungal API with activity against dermatophytes and is widely used in pharmaceutical formulations for fungal infections.
The FDA-approved oral dosage form contains Terbinafine Hydrochloride USP as the active ingredient, equivalent to terbinafine. The approved tablet strength is 250 mg.
Terbinafine Hydrochloride is described as a white to off-white fine crystalline powder. It is freely soluble in methanol and methylene chloride, soluble in ethanol, and slightly soluble in water.
Product Name: Terbinafine Hydrochloride
Common Name: Terbinafine HCl
CAS No.: 78628-80-5
Molecular Formula: C₂₁H₂₆ClN
Molecular Weight: 327.90 g/mol
Therapeutic Category: Antifungal
Drug Class: Allylamine Antifungal
Active Moiety: Terbinafine
Dosage-Form Applications: Oral and topical pharmaceutical formulations
The chemical identity, CAS number, formula and molecular weight are supported by PubChem and FDA labeling.
Terbinafine Hydrochloride API is used in the manufacture of pharmaceutical products intended for antifungal therapy, including:
FDA-approved oral terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail caused by dermatophytes.
Terbinafine inhibits the fungal enzyme squalene epoxidase, which plays an important role in ergosterol biosynthesis. Inhibition of this enzyme interferes with fungal sterol production and results in accumulation of squalene within fungal cells.
This mechanism gives Terbinafine its characteristic allylamine antifungal activity against susceptible dermatophytes.
Terbinafine Hydrochloride API should undergo appropriate pharmaceutical quality testing to establish identity, assay, purity and control of process-related and degradation impurities.
Typical analytical controls may include:
The exact numerical release limits should be based on the applicable pharmacopoeial monograph and the manufacturer's approved specification. This avoids presenting an unrelated commercial specification as a universal API standard.
Swapnroop manufactures pharmaceutical APIs with emphasis on controlled processes, analytical quality control and consistent batch-to-batch performance.
Terbinafine Hydrochloride manufacturing requires control of raw materials, reaction parameters, impurity formation, purification, drying and final API testing. Appropriate analytical methods are used to confirm the identity and quality of the finished active pharmaceutical ingredient.
Swapnroop focuses on supplying Terbinafine Hydrochloride API for pharmaceutical manufacturing with documentation and quality controls appropriate to customer and regulatory requirements.
Terbinafine Hydrochloride API should be packed in suitable pharmaceutical-grade packaging that protects the material against moisture, contamination and environmental exposure.
Storage conditions should follow the approved product specification and available stability data. The API should remain in its original, properly closed packaging until use.
Depending on customer and regulatory requirements, documentation may include:
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |