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Merck
모든 사진(1)

문서

PHR1298

Supelco

Terbinafine hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

동의어(들):

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

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About This Item

실험식(Hill 표기법):
C21H25N · HCl
CAS Number:
Molecular Weight:
327.89
MDL number:
UNSPSC 코드:
41116107
PubChem Substance ID:
NACRES:
NA.24

Grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to Ph. Eur. Y0000535
traceable to USP 1643496

API family

terbinafine

CofA

current certificate can be downloaded

기술

HPLC: suitable
gas chromatography (GC): suitable

응용 분야

pharmaceutical (small molecule)

형식

neat

저장 온도

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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일반 설명

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.

애플리케이션

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.

생화학적/생리학적 작용

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

분석 메모

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

기타 정보

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.

각주

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.

픽토그램

Exclamation markEnvironment

신호어

Warning

유해 및 위험 성명서

Hazard Classifications

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

표적 기관

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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시험 성적서(COA)

Lot/Batch Number

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If you require a particular version, you can look up a specific certificate by the Lot or Batch number.

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문서 라이브러리 방문

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)
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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