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PHR1298 Supelco

Terbinafine hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym: trans-N-(6,6-Dimethyl-2-hepten-4-ylyl)-N-methyl-1-naphthylmethylamine hydrochloride

  • CAS Number 78628-80-5

  • Empirical Formula (Hill Notation) C21H25N · HCl

  • Molecular Weight 327.89

  •  MDL number MFCD00145430

  •  PubChem Substance ID 329823287

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Properties

Related Categories Additional Standards, Analytical Standards, Analytical/Chromatography, Chromatography, I-Z,
grade   certified reference material
  pharmaceutical secondary standard
InChI Key   BWMISRWJRUSYEX-SZKNIZGXSA-N
form   neat
Featured Industry   Pharmaceutical (small molecule)
format   neat
pharmacopeia traceability   traceable to PhEur Y0000535
  traceable to USP 1643496

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.
Antimicrobial spectrum: Antifungal and antimycotic. Fungicidal against dermatopytes and some yeasts; fungistatic against Candida albicans.

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 LRAA0490 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety & Documentation

Safety Information

Symbol 
Signal word 
Warning
Hazard statements 
Precautionary statements 
RIDADR 
UN 3077 9 / PGIII
WGK Germany 
3

Documents

Certificate of Analysis (COA)

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Protocols & Articles
Peer-Reviewed Papers
15

References

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