PHR1298

Terbinafine hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): trans-N-(6,6-Dimethyl-2-hepten-4-ylyl)-N-methyl-1-naphthylmethylamine hydrochloride
• Empirical Formula (Hill Notation): C₂₁H₂₅N · HCl
• CAS Number: 78628-80-5
• Molecular Weight: 327.89
• MDL number: MFCD00145430
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823287
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to Ph. Eur. Y0000535; traceable to USP 1643496
• API family: terbinafine
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• SMILES string: Cl[H].[H]\C(CN(C)Cc1cccc2ccccc12)=C(\[H])C#CC(C)(C)C
• InChI: 1S/C21H25N.ClH/c1-21(2,3)15-8-5-9-16-22(4)17-19-13-10-12-18-11-6-7-14-20(18)19;/h5-7,9-14H,16-17H2,1-4H3;1H/b9-5+;
• InChI key: BWMISRWJRUSYEX-SZKNIZGXSA-N

Description

General description

Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to pharmacopeia primary standards. Terbinafine hydrochloride is an antifungal drug. Its mode of action involves the inhibition of squalene epoxidase enzyme, an essential component of fungal cell systems involved in ergosterol biosynthesis.

Allylamine derivative.

Application

Terbinafine hydrochloride may be used as a pharmaceutical reference standard for the determination of the analyte in drug dosage forms by UV spectrophotometry and high-performance thin layer chromatography (HPTLC).

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Biochem/physiol Actions

Mode of Action: Inhibits squalene epoxidase, preventing biosynthesis of ergosterol.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC3257 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS07,GHS09
• Signal Word: Warning
• Hazard Statements: H315 - H319 - H335 - H410
• Precautionary Statements: P261 - P273 - P305 + P351 + P338 - P501
• Hazard Classifications: Aquatic Acute 1 - Aquatic Chronic 1 - Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3
• Target Organs: Respiratory system
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable