Terbinafine HCl

CAS NO.: 78628-80-5 EINECS:N

Molecular Formula: C₂₁H₂₅N.HCl;C₂₁H₂₆ClN Molecular Weight: 327.90

Molecular Structure:

Property:

The melting point of terbinafine HCl is 204-208 ºC. Antifungal, allylamine -one of the first antifungals of the allylamine class, discovered in 1974. Terbinafine HCL was approved for systemic use in the UK in 1991, and for topical use in the USA in 1992.

Terbinafine is an antifungal effective against Dermatophytes, Aspergillus sp., and Candida and Pityrosporum yeasts. Terbinafine is only fungistatic against Candida, however cure is possible after 2-4 weeks of treatment (-).

Terbinafine HCL is available in systemic and topical formulations. Systemic treatment is usually reserved for infections of the nails, extensive cutaneous infections or those, which have not responded to topical therapy.

Specifications：

Item	Index
Appearance	White or off-white powder
Identification	IR, UV
Solubility	Very slightly or slightly soluble in water, Freely soluble in anhydrous ethanol and methanol, slightly soluble in acetone.
Assay	99～101% （Titration）
Related Substances	Impurity A≤0.1% Impurity B≤0.1% Impurity C≤0.1% Impurity D≤0.1% Single unknown impurity≤0.05% Total impurities≤0.3%
Loss on drying	≤0.5%
Heavy metals	≤10ppm
PH	3.0～4.5
Residue on ignition	≤0.1%

Usage:

Terbinafine is a broad-spectrum antifungal agent. Terbinafine belongs to the family of allylamine structure antifungal agent such as amorolfine, naftifine, butenafine which interferes with biosynthesis of ergosterol needed for the fungal cell membrane. Allylamine antifungal agents are highly lipophilic and are applied topically to the skin, nails, and fatty tissues. Chemically terbinafine is (e)-N-(6,6-dimethyl-2-hepten-4-ynyl)- N-methyl- 1- naphthalenemethanamine. Terbinafine hydrochloride is a white to off- white fine crystalline powder; slightly soluble in water, freely soluble in lower alcohol and methylene chloride. Terbinafine is also used as a trypanocidal agent.

Package and Storage:

Keep in shaded, cool 25kg fiber drum and air places. The shelf time is 2 years.

Key Words:

Terbinafine hydrochloride (E)-N-(6,6-Dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine monohydrochloride