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Merck
CN

PHR1725

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, 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, Glimepiride EP Impurity A, 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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关于此项目

经验公式（希尔记法）:
C24H34N4O5S
化学文摘社编号:
684286-46-2
分子量:
490.62
UNSPSC Code:
41116107
NACRES:
NA.24

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产品名称

格列美脲相关化合物A, Pharmaceutical Secondary Standard; Certified Reference Material

SMILES string

[S](=O)(=O)(NC(=O)N[C@@H]3CC[C@@H](CC3)C)c1ccc(cc1)CCNC(=O)N2CC(=C(C2=O)CC)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 key

WIGIZIANZCJQQY-UWUNEBHHSA-N

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to USP 1292314

API family

glimepiride

CofA

current certificate can be downloaded

packaging

pkg of 40 mg

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

Analysis Note

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

Application

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.

General description

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.

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 LRAA7400 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Health hazard
GHS08

signalword

Warning

hcodes

H361d

Hazard Classifications

Repr. 2

存储类别

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

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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)
Glimepiride
USP42-NF37: United States Pharmacopeia and National Formulary
United States Pharmacopeia/National Formulary, 42(6), 2062-2062 (2018)
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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