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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关于此项目
经验公式（希尔记法）:
C21H25N · HCl
化学文摘社编号:
分子量:
327.89
NACRES:
NA.24
PubChem Substance ID:
UNSPSC Code:
41116107
MDL number:
Quality Level
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
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
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.
烯丙胺衍生物。
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 US and EP 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.
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.
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signalword
Warning
hcodes
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
flash_point_f
Not applicable
flash_point_c
Not applicable
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)
全球贸易项目编号
| 货号 | GTIN |
|---|---|
| PHR1298-1G | 04061834415763 |