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Merck

PHR1298

Supelco

Terbinafin -hydrochlorid

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(e):

trans-N-(6,6-Dimethyl-2-hepten-4-ylyl)-N-methyl-1-naphthylmethylamin -hydrochlorid

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About This Item

Empirische Formel (Hill-System):
C21H25N · HCl
CAS-Nummer:
Molekulargewicht:
327.89
MDL-Nummer:
UNSPSC-Code:
41116107
PubChem Substanz-ID:
NACRES:
NA.24

Qualität

certified reference material
pharmaceutical secondary standard

Qualitätsniveau

Agentur

traceable to Ph. Eur. Y0000535
traceable to USP 1643496

API-Familie

terbinafine

Analysenzertifikat (CofA)

current certificate can be downloaded

Methode(n)

HPLC: suitable
gas chromatography (GC): suitable

Anwendung(en)

pharmaceutical (small molecule)

Format

neat

Lagertemp.

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+;

InChIKey

BWMISRWJRUSYEX-SZKNIZGXSA-N

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Allgemeine Beschreibung

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.
Allylamin-Derivat.

Anwendung

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. Wirkung

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

Hinweis zur Analyse

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

Sonstige Hinweise

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.

Fußnote

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.

Piktogramme

Exclamation markEnvironment

Signalwort

Warning

Gefahreneinstufungen

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

Zielorgane

Respiratory system

Lagerklassenschlüssel

11 - Combustible Solids

WGK

WGK 3

Flammpunkt (°F)

Not applicable

Flammpunkt (°C)

Not applicable


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Analysenzertifikate (COA)

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Kunden haben sich ebenfalls angesehen

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)
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)
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)
Determination of terbinafine hydrochloride by ion-pair reversed phase liquid chromatography.
Florea M, et al.
Farmacia, 57, 82-88 (2009)
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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