Trimeprazine Tartrate (Alimemazine Tartrate BP/USP)

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Terbinafine Hydrochloride

N-[(2E)-6,6-Dimethyl-2-hepten-4-ynyl]-N-methyl-1-naphthalenemethanamine

C₂₁H₂₅N*HCl
Mol. Wt.: 327.90
CAS 78628-80-5

Description
White to off-white crystalline powder

Medical Use/Therapeutic Category
Antifungal (oral and topical)
Antimycotic (oral and topical)

Solubility
- Soluble in methanol or methylene chloride
- Slightly soluble in water
- Sparingly soluble in acetone, 2-propanol or ethanol
- Insoluble in toluene

Identification
A. Infrared spectrum: Conforms to that of the Reference Standard
B. HPLC

Characteristics of a 10% solution in Methanol
Appearance: Not more opalescent than Reference Standard III and slightly
yellow

pH
3.5 to 4.5 (0.1 % aqueous solution)

Chromatographic purity (Related compounds)
Any individual unknown compound: Not more than 0.1 %
Total impurities: Not more than 0.5 %

Assay
98.0 – 102.0 % (on anhydrous basis)

Other Tests
Heavy metals: Not more than 20 ppm
Residue on ignition: Not more than 0.1%
Water content: Not more than 0.5%

Specifications and Analytical Methods – available upon request