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Terbinafine hydrochloride Terbinafine HCL Terbinafine 99% 78628-80-5 EP7.0 USP35
Product name |
TERBINAFINE HCl (78628-80-5) |
Items |
Standard |
Results |
|
Appearance |
White or off-white powder |
Complies |
|
Identification |
UV,IR |
Complies |
|
Solubility |
Very slightly and slightly soluble in water, freely soluble in anhydrous ethanol and methanol, slightly soluble in acetone |
Complies |
|
Related Substances |
Impurity B |
≤0.1% |
0.020% |
Single unknown impurity |
≤0.05% |
0.031% |
|
Total impurity |
≤0.3% |
0.079% |
|
Loss on drying |
≤0.5 % |
0.07 % |
|
Heavy metals |
≤20mm |
Complies |
|
PH |
3.0~4.5 |
3.98 |
|
Residue on ignition |
≤0.10 % |
0.03% |
|
Assay |
99~101 % (Titration) |
99.82 % |
|
Storage |
Keep tightly closed, Store in cool and dry place |
||
Determination |
Complies with EP6 standard |
Identification | ||
Name | Terbinafine hydrochloride | |
Synonyms | (E)-N-(6,6-Dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine monohydrochloride |
Product name |
TERBINAFINE HCl (78628-80-5) |
Items |
Standard |
Results |
|
Appearance |
White or off-white powder |
Complies |
|
Identification |
UV,IR |
Complies |
|
Solubility |
Very slightly and slightly soluble in water, freely soluble in anhydrous ethanol and methanol, slightly soluble in acetone |
Complies |
|
Related Substances |
Impurity B |
≤0.1% |
0.020% |
Single unknown impurity |
≤0.05% |
0.031% |
|
Total impurity |
≤0.3% |
0.079% |
|
Loss on drying |
≤0.5 % |
0.07 % |
|
Heavy metals |
≤20mm |
Complies |
|
PH |
3.0~4.5 |
3.98 |
|
Residue on ignition |
≤0.10 % |
0.03% |
|
Assay |
99~101 % (Titration) |
99.82 % |
|
Storage |
Keep tightly closed, Store in cool and dry place |
||
Determination |
Complies with EP6 standard |
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