PHR1298

Terbinafine

Pharmaceutical Secondary Standard; Certified Reference Material

• Sinonimo/i: trans-N-(6,6-Dimethyl-2-hepten-4-ylyl)-N-methyl-1-naphthylmethylamine
• Formula empirica (notazione di Hill): C₂₁H₂₅N · HCl
• Numero CAS: 78628-80-5
• Peso molecolare: 327.89
• Numero MDL: MFCD00145430
• Codice UNSPSC: 41116107
• ID PubChem: 329823287
• NACRES: NA.24

Proprietà

• Grado: certified reference material; pharmaceutical secondary standard
• Livello qualitativo: 300
• agenzia: traceable to Ph. Eur. Y0000535; traceable to USP 1643496
• Famiglia di API: terbinafine
• CdA: current certificate can be downloaded
• tecniche: HPLC: suitable; gas chromatography (GC): suitable
• applicazioni: pharmaceutical (small molecule)
• Formato: neat
• Temperatura di conservazione: 2-30°C
• Stringa SMILE: 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+;; BWMISRWJRUSYEX-SZKNIZGXSA-N

Descrizione

Descrizione generale

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.

Applicazioni

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.

Azioni biochim/fisiol

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

Risultati analitici

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

Altre note

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 a piè di pagina

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.

Informazioni sulla sicurezza

• Pittogrammi: GHS07,GHS09
• Avvertenze: Warning
• Indicazioni di pericolo: H315,H319,H335,H410
• Consigli di prudenza: P261 - P273 - P305 + P351 + P338 - P501
• Classi di pericolo: Aquatic Acute 1 - Aquatic Chronic 1 - Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3
• Organi bersaglio: Respiratory system
• Codice della classe di stoccaggio: 11 - Combustible Solids
• Classe di pericolosità dell'acqua (WGK): WGK 3
• Punto d’infiammabilità (°F): Not applicable
• Punto d’infiammabilità (°C): Not applicable