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重要文件

PHR1298

Supelco

特比萘芬 盐酸盐

Pharmaceutical Secondary Standard; Certified Reference Material

同義詞:

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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About This Item

經驗公式(希爾表示法):
C21H25N · HCl
CAS號碼:
分子量::
327.89
MDL號碼:
分類程式碼代碼:
41116107
PubChem物質ID:
NACRES:
NA.24

等級

certified reference material
pharmaceutical secondary standard

品質等級

agency

traceable to Ph. Eur. Y0000535
traceable to USP 1643496

API 家族

terbinafine

CofA

current certificate can be downloaded

技術

HPLC: suitable
gas chromatography (GC): suitable

應用

pharmaceutical (small molecule)

形式

neat

儲存溫度

2-30°C

SMILES 字串

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 密鑰

BWMISRWJRUSYEX-SZKNIZGXSA-N

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一般說明

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.

應用

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.

生化/生理作用

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

分析報告

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

其他說明

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.

腳註

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.

象形圖

Exclamation markEnvironment

訊號詞

Warning

危險分類

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

標靶器官

Respiratory system

儲存類別代碼

11 - Combustible Solids

水污染物質分類(WGK)

WGK 3

閃點(°F)

Not applicable

閃點(°C)

Not applicable


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分析證明 (COA)

Lot/Batch Number

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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)
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)
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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