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Merck
CN

PHR1298

特比萘芬 盐酸盐

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

反式-N-（6,6-二甲基-2-庚-4-基）-N-甲基-1-萘甲胺 盐酸盐

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经验公式（希尔记法）:
C21H25N · HCl
化学文摘社编号:
78628-80-5
分子量:
327.89
NACRES:
NA.24
PubChem Substance ID:
329823287
UNSPSC Code:
41116107
MDL number:
MFCD00145430

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产品名称

特比萘芬 盐酸盐, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

BWMISRWJRUSYEX-SZKNIZGXSA-N

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+;

grade

certified reference material
pharmaceutical secondary standard

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

Quality Level

300

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相关类别

General description

烯丙胺衍生物。
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.

Analysis Note

These secondary standards offer multi-traceability to the US and EP 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).
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.

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.
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.

pictograms

Exclamation markEnvironment
GHS07,GHS09

signalword

Warning

Hazard Classifications

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

target_organs

Respiratory system

存储类别

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

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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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