Terbinafine hydrochloride
SIAL/PHR1298 - Pharmaceutical Secondary Standard; Certified Reference Material
Synonym: trans-
CAS Number: 78628-80-5
Empirical Formula (Hill Notation): C21H25N · HCl
Molecular Weight: 327.89
MDL Number: MFCD00145430
Linear Formula: C21H25N · HCl
Product Type: Chemical
| agency | traceable to Ph. Eur. Y0000535 |
| traceable to USP 1643496 | |
| application(s) | pharmaceutical (small molecule) |
| CofA | current certificate can be downloaded |
| format | neat |
| grade | certified reference material |
| pharmaceutical secondary standard | |
| InChI | 1S/C21H25N.ClH/c1-21(2,3) |
| InChI key | BWMISRWJRUSYEX-SZKNIZGXSA |
| Quality Level | 300  |
| SMILES string | Cl[H].[H]C(CN(C)Cc1cccc2 |
| storage temp. | 2-30°C |
| technique(s) | gas chromatography (GC): suitable |
| HPLC: suitable |
| Analysis Note: | These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available. |
| 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). |
| Application: | 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. Antimicrobial spectrum: Antifungal and antimycotic. Fungicidal against dermatopytes and some yeasts; fungistatic against Candida albicans. |
| 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. |
| General description: | Allylamine derivative. |
| 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. |
| 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. |
| Symbol |   GHS07,GHS09 |
| Signal word | Warning |
| Hazard statements | H315 - H319 - H335 - H410 |
| Precautionary statements | P261 - P273 - P305 + P351 + P338 - P501 |
| Hazard Codes | Xi,N |
| Risk Statements | 36/37/38-50/53 |
| Safety Statements | 26-60-61 |
| RIDADR | UN 3077 9 / PGIII |
| WGK Germany | WGK 3 |
| Flash Point(F) | Not applicable |
| Flash Point(C) | Not applicable |
| Storage Temp. | 2-30°C |
| UNSPSC | 41116107 |