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Merck

PHR1725

Supelco

格列美脲相关化合物A

Pharmaceutical Secondary Standard; Certified Reference Material

别名:

3-Ethyl-2,5-dihydro-4-methyl-N-[2-[4-[[[[(cis-4-methylcyclohexyl)amino]carbonyl]amino]sulfonyl]phenyl]ethyl]-2-oxo-1H-pyrrole-1-carboxamide, 1-[[p-[2-(3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(cis-4-methylcyclohexyl)urea, Glimepiride cis-isomer

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About This Item

经验公式(希尔记法):
C24H34N4O5S
分子量:
490.62
分類程式碼代碼:
41116107
NACRES:
NA.24

等級

certified reference material
pharmaceutical secondary standard

品質等級

agency

traceable to USP 1292314

API 家族

glimepiride

CofA

current certificate can be downloaded

包裝

pkg of 40 mg

技術

HPLC: suitable
gas chromatography (GC): suitable

應用

pharmaceutical (small molecule)

格式

neat

儲存溫度

2-30°C

InChI

1S/C24H34N4O5S/c1-4-21-17(3)15-28(22(21)29)24(31)25-14-13-18-7-11-20(12-8-18)34(32,33)27-23(30)26-19-9-5-16(2)6-10-19/h7-8,11-12,16,19H,4-6,9-10,13-15H2,1-3H3,(H,25,31)(H2,26,27,30)/t16-,19+

InChI 密鑰

WIGIZIANZCJQQY-UWUNEBHHSA-N

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一般說明

Glimepiride cis-Isomer (Glimepiride Related Compound A) is an impurity of glimepiride. Glimepiride is a third generation, medium-to-long acting sulphonylurea compound used as an oral antidiabetic drug. Its mode of action involves the lowering of blood glucose by stimulating the release of insulin from functioning pancreatic beta cells.
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

應用

Glimepiride cis-Isomer (Glimepiride Related Compound A) may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography techniques.
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.

分析報告

These secondary standards offer multi-traceability to the USP, EP 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 LRAA7400 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

象形圖

Health hazard

訊號詞

Warning

危險聲明

危險分類

Repr. 2

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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分析证书(COA)

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访问文档库

Glimepiride
USP42-NF37: United States Pharmacopeia and National Formulary
United States Pharmacopeia/National Formulary, 42(6), 2062-2062 (2018)
LC determination of glimepiride and its related impurities
Khan MA, et al.
Journal of Pharmaceutical and Biomedical Analysis, 39(5), 928-943 (2005)
RP-HPLC analytical method development and validation for simultaneous estimation of three drugs: Glimepiride, pioglitazone, and metformin and its pharmaceutical dosage forms
Nirupa G and Tripathi UM
Journal of Chemistry, 2013(5), 550-559 (2012)
Rudy Bonfilio et al.
Therapeutic drug monitoring, 32(5), 550-559 (2010-08-26)
Glimepiride is an oral antidiabetic drug in the sulfonylurea class, which is widely used in treatment of Type 2 diabetes and it is currently available in more than 60 countries worldwide. As a result of the importance of this oral

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