Property Description
Chemical Name:Terbinafine Hydrochloride
IUPAC Name:(E)-N-(6,6-Dimethyl-2-hepten-4-yn-1-yl)-N-methyl-1-naphthalenemethanamine hydrochloride
CAS:78628-80-5
Molecular Formula:C<sub>21</sub>H<sub>25</sub>N·HCl
Molecular Weight:327.89 g/mol
Appearance:White to off-white crystalline powder
Melting Point:195-198°C (dec.)
Solubility - Water: Slightly soluble
- Methanol/Ethanol: Freely soluble
- Chloroform: Soluble
Pharmacological Class:Allylamine antifungal
Mechanism of Action:Inhibits squalene epoxidase, blocking ergosterol synthesis in fungal cell membranes.
Indication:Treatment of fungal infections (dermatophytes, onychomycosis).
Approval:Approved in 1996 (oral), 1991 (topical)
Chemical Structure:Naphthalene derivative with a tertiary amine group and unsaturated side chain (alkynyl).
Stability:Stable under normal storage conditions (protect from light and moisture).
| Parameter | Specification | Test Method | Result |
|---|
| Appearance | White to off-white crystalline powder | Visual inspection | Complies |
| Identification | IR spectrum matches reference standard | USP <197> / FTIR | Complies |
| Assay (HPLC) | 98.0% - 102.0% (anhydrous basis) | USP <621> (Reverse-phase HPLC) | 99.3% |
| Related Substances | - Individual impurity ≤ 0.5%
- Total impurities ≤ 1.5% | HPLC (USP <621>) | 0.8% (Total) |
| Water Content (KF) | ≤ 0.5% w/w | Karl Fischer titration | 0.2% |
| Residual Solvents | - Methanol ≤ 3000 ppm
- Acetone ≤ 5000 ppm | GC (USP <467>) | <100 ppm |
| Heavy Metals | ≤ 10 ppm (as Pb) | USP <231> / ICP-MS | <5 ppm |
| Sulfated Ash | ≤ 0.1% | USP <281> | 0.05% |
| pH (1% Solution) | 4.5 - 6.0 | USP <791> | 5.2 |
| Melting Point | 195-198°C (with decomposition) | USP <741> | 196°C (dec.) |
| Microbial Limits | - TAMC ≤ 1000 CFU/g
- TYMC ≤ 100 CFU/g | USP <61> | Complies |
| Optical Rotation | +0.5° to +2.5° (c=1 in methanol) | USP <781> | +1.8° |
China
