PHR1298

Terbinafine hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

• Sinônimo(s): trans-N-(6,6-Dimethyl-2-hepten-4-ylyl)-N-methyl-1-naphthylmethylamine hydrochloride
• Fórmula empírica (Notação de Hill): C₂₁H₂₅N · HCl
• Número CAS: 78628-80-5
• Peso molecular: 327.89
• Número MDL: MFCD00145430
• Código UNSPSC: 41116107
• ID de substância PubChem: 329823287
• NACRES: NA.24

Propriedades

• grau: certified reference material; pharmaceutical secondary standard
• Nível de qualidade: 300
• Agency: traceable to Ph. Eur. Y0000535; traceable to USP 1643496
• família API: terbinafine
• Certificado de análise (CofA): current certificate can be downloaded
• técnica(s): HPLC: suitable; gas chromatography (GC): suitable
• aplicação(ões): pharmaceutical (small molecule)
• Formato: neat
• temperatura de armazenamento: 2-30°C
• cadeia de caracteres 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+;
• chave InChI: BWMISRWJRUSYEX-SZKNIZGXSA-N

Descrição

Descrição geral

Allylamine derivative.

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.

Aplicação

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.

Ações bioquímicas/fisiológicas

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

Nota de análise

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

Outras notas

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.

Nota de rodapé

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.

Informações de segurança

• Pictogramas: GHS07,GHS09
• Palavra indicadora: Warning
• Frases de perigo: H315,H319,H335,H410
• Declarações de precaução: P261 - P273 - P305 + P351 + P338 - P501
• Classificações de perigo: Aquatic Acute 1 - Aquatic Chronic 1 - Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3
• Órgãos-alvo: Respiratory system
• Código de classe de armazenamento: 11 - Combustible Solids
• Classe de risco de água (WGK): WGK 3
• Ponto de fulgor (°F): Not applicable
• Ponto de fulgor (°C): Not applicable