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PHR1298

Terbinafine hydrochloride

Name: Terbinafine hydrochloride
Brand: SIAL

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

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

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About This Item

Empirical Formula (Hill Notation):

C₂₁H₂₅N · HCl

CAS Number:

78628-80-5

Molecular Weight:

327.89

MDL number:

MFCD00145430

UNSPSC Code:

41116107

PubChem Substance ID:

329823287

NACRES:

NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to Ph. Eur. Y0000535
traceable to USP 1643496

API family

terbinafine

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

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+;

InChI key

BWMISRWJRUSYEX-SZKNIZGXSA-N

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Related Categories

Analytical Reference Standards

Certified Reference Materials

Pharmacopeia & Metrological Institute Standards

General description

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.

Biochem/physiol Actions

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

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 LRAC3257 in the slot below. This is an example certificate only and may not be the lot that you receive.

related product

Product No.

Description

Pricing

1643532

1437701

1424608

1353215

BP1159

Terbinafine hydrochloride, British Pharmacopoeia (BP) Reference Standard

PHR2927

PHR2885

Pictograms

GHS07,GHS09

Signal Word

Warning

Hazard Statements

H315,H319,H335,H410

Precautionary Statements

P261 - P273 - P305 + P351 + P338 - P501

Hazard Classifications

Aquatic Acute 1 - Aquatic Chronic 1 - Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3

Target Organs

Respiratory system

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

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Determination of terbinafine hydrochloride by ion-pair reversed phase liquid chromatography.

Florea M, et al.

Farmacia, 57, 82-88 (2009)

Development and validation of the UV-spectrophotometric method for determination of terbinafine hydrochloride in bulk and in formulation.

Jain PS, et al.

Pharmaceutical Methods, 2(3), 198-202 (2011)

A validated HPTLC method for determination of Terbinafine hydrochloride in pharmaceutical solid dosage form.

Patel KK and Karkhanis VV

International Journal of Pharmaceutical Sciences and Research, 3(11), 4492-4495 (2012)

UV spectrophotometry and nonaqueous determination of terbinafine hydrochloride in dosage forms.

Cardoso SG and Schapoval EE

Journal of AOAC (Association of Official Analytical Chemists) International, 82, 830-833 (1999)

Selective extraction of antimycotic drugs from sludge samples using matrix solid-phase dispersion followed by on-line clean-up.

Jorge Casado et al.

Analytical and bioanalytical chemistry, 407(3), 907-917 (2014-09-28)

An effective and selective, modular sample preparation method for the extraction of eight antimycotic drugs, belonging to three different chemical classes, from digested sludge samples is proposed. To this end, matrix solid-phase dispersion (MSPD) was on-line connected with a cationic

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