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PHR1725

Glimepiride cis-Isomer (Glimepiride Related Compound A)

Name: Glimepiride cis-Isomer (Glimepiride Related Compound A)
Brand: SIAL

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

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

Empirical Formula (Hill Notation):

C₂₄H₃₄N₄O₅S

CAS Number:

684286-46-2

Molecular Weight:

490.62

UNSPSC Code:

41116107

NACRES:

NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

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

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

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Related Categories

Analytical Reference Standards

Certified Reference Materials

Pharmacopeia & Metrological Institute Standards

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.

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.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP 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.

Footnote

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.

related product

Product No.

Description

Pricing

1292303

Glimepiride, United States Pharmacopeia (USP) Reference Standard

1292325

Y0000516

Glimepiride for system suitability, European Pharmacopoeia (EP) Reference Standard

Y0000515

Glimepiride, European Pharmacopoeia (EP) Reference Standard

1292336

1292347

Y0001742

Glimepiride for impurity A identification, European Pharmacopoeia (EP) Reference Standard

PHR1617

Glimepiride, Pharmaceutical Secondary Standard; Certified Reference Material

PHR1727

Signal Word

Warning

Hazard Statements

H361d

Precautionary Statements

P201 - P202 - P280 - P308 + P313 - P405 - P501

Hazard Classifications

Repr. 2

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Choose from one of the most recent versions:

Certificates of Analysis (COA)

Lot/Batch Number

LRAC2872

LRAD2148

LRAA7400

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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)

A review of analytical techniques for determination of glimepiride: present and perspectives.

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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