PHR1298

Terbinafine hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonyme(s) : trans-N-(6,6-Dimethyl-2-hepten-4-ylyl)-N-methyl-1-naphthylmethylamine hydrochloride
• Formule empirique (notation de Hill): C₂₁H₂₅N · HCl
• Numéro CAS: 78628-80-5
• Poids moléculaire : 327.89
• Numéro MDL: MFCD00145430
• Code UNSPSC : 41116107
• ID de substance PubChem : 329823287
• Nomenclature NACRES : NA.24

Propriétés

• Qualité: certified reference material; pharmaceutical secondary standard
• Niveau de qualité: 300
• Agence: traceable to Ph. Eur. Y0000535; traceable to USP 1643496
• Famille d'API: terbinafine
• CofA (certificat d'analyse): current certificate can be downloaded
• Technique(s): HPLC: suitable; gas chromatography (GC): suitable
• Application(s): pharmaceutical (small molecule)
• Format: neat
• Température de stockage: 2-30°C
• Chaîne SMILES: 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+;
• Clé InChI: BWMISRWJRUSYEX-SZKNIZGXSA-N

Description

Description générale

Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to in-house working 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.

Actions biochimiques/physiologiques

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

Remarque sur l'analyse

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

Autres remarques

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.

Note de bas de page

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.

Informations sur la sécurité

• Pictogrammes: GHS07,GHS09
• Mention d'avertissement: Warning
• Mentions de danger: H315,H319,H335,H410
• Conseils de prudence: P261 - P273 - P305 + P351 + P338 - P501
• Classification des risques: Aquatic Acute 1 - Aquatic Chronic 1 - Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3
• Organes cibles: Respiratory system
• Code de la classe de stockage: 11 - Combustible Solids
• Classe de danger pour l'eau (WGK): WGK 3
• Point d'éclair (°F): Not applicable
• Point d'éclair (°C): Not applicable