Complaint
Pharmaceutical Raw Powder 99% Terbinafine Hydrochloride Terbinafine HCl
Terbinafine hydrochloride is an antifungal, which is highly hydrophobic and tends to accumulate in hair, skin, nails, and fatty tissue.
Terbinafine hydrochloride is a white fine crystalline powder that is freely soluble in methanol and dichloromethane, soluble in ethanol, and slightly soluble in water.
Like other allylamines, terbinafine inhibits ergosterol synthesis by inhibiting squalene epoxidase, an enzyme that is part of the fungal cell membrane synthesis pathway. Because terbinafine prevents conversion of squalene to lanosterol, ergosterol cannot be synthesize.
Product Name | Terbinafine hydrochloride |
CAS | 78628-80-5 |
Appearance | White or almost white crystalline powder |
MF | C21H26ClN |
Molecular Weight | 327.89 |
Purity | 99% min |
Storage | Keep in a cool, dry, dark location in a tightly sealed container or cylinder |
Shelf Life | 24 Months |
| Items of analysis | Specification | Results | |
| Appearance | White or similar white powder, soluble in anhydrous ethanol and methanol, slightly soluble in acetone, extremely soluble in water | Conforms | |
| Identify | Comply with the standard | Conforms | |
| Impurity B | ≤0.15% | 0.001% | |
| Impurity E | ≤0.05% | 0.001% | |
| Unknown single impurity | ≤0.1% | 0.03% | |
| Total impurity | ≤0.3% | 0.1% | |
| sulphated ash | ≤0.1% | 0.05% | |
| Loss on dry | ≤0.5% | 0.2% | |
| ignition residue | ≤0.1% | 0.021% | |
| residual solvent | isopropanol≤5000ppm;ethyl acetate≤5000ppm;trichloromethane≤60ppm | Isopropanol 5ppm;ethyl acetate 101ppm;trichloromethane not detected | |
| Assay | 99-101% | 99.7% | |
