| Customization: | Available |
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| Powder: | Yes |
| Customized: | Customized |
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Product Name: Terbinafine
Synonyms: trans-N-(6,6-Dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthylmethylamine;LAMISIL;(e)-n-(6,6-dimethyl-2-hepten-4-ynyl)-n-methyl-1-naphthalenemethanamine;6-dimethyl-2-hepten-4-ynyl)-n-methyl-n-((e)-1-naphthalenemethanamin;sf-86-327;TERBINAFINE;1-Naphthalenemethanamine, N-(2E)-6,6-dimethyl-2-hepten-4-ynyl-N-methyl-;(E)-N-(6,6-I)imethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine
CAS: 91161-71-6
MF: C21H25N
MW: 291.43
EINECS: 618-706-8
Product Categories: Inhibitors;Active Pharmaceutical Ingredients;Terbinafine;API
Terbinafine is a second-generation that is related to naftifine; however, it is 10 to 100 times more potent in vitro. It is fungicidal, whereas griseofulvin,derivatives are all fungistatic. Because it is fungicidal, duration of therapy is shorter, and relapse rates are less than with other oral or topical therapies. Terbinafine acts by inhibiting squalene epoxidase and thereby decreasing synthesis of ergosterol, an essential component of fungal cell membranes. It is highly lipophilic and concentrates in the stratum corneum, sebum, and hair follicles. Slightly better cure rates are attained with b.i.d. than with daily dosing.
Certificate of analysis
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Item Of Analysis |
Standard |
Result Of Analysis |
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Description |
White or almost white powder |
almost white powder |
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Solubility |
Very slightly or slightly soluble in water, freely soluble in anhydrous ethanol and in methano.l, slightly soluble in aceton.e |
Complies |
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Identification |
Infrared absorption spectrophotometry. Comparison: terbinafine hydrochloride CRS |
Complies |
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It gives reaction (a) of chlorides using anhydrous ethanol R as solvent |
Complies | |
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Related Substances |
Impurity B: not more than 0.15%, |
Complies
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Impurity E: not more than 0.05%, impurity |
Complies |
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unspecified impurities:each Impuritynot more than 0.1% |
Complies |
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Sum of impurity : not more than 0.3% |
Complies |
|
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Loss on drying |
≤0.5% |
0.40% |
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Sulfated ash |
≤0.1% |
0.01% |
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Residual Solvent |
ethyl aceta.te≤0.5% |
ethyl acetat.e≤0.5% |
| dichloromethan.e≤0.06% | dichloromethan.e≤0.06% | |
| isopropano.l≤0.5% | isopropano.l≤0.5% | |
|
Assay |
99.0%-101.0% |
100.29% |
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