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Key Documents

PHR1617

Supelco

Glimepiride

Pharmaceutical Secondary Standard; Certified Reference Material

Sinonimo/i:

Glimepiride, trans-3-Ethyl-2,5-dihydro-4-methyl-N-[N-[4-[[[[(4-methylcyclohexyl)amino]carbonyl]amino]sulfonyl]phenyl]ethyl]-2-oxo-1H-pyrrole-1-carboxamide, HOE-490

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About This Item

Formula empirica (notazione di Hill):
C24H34N4O5S
Numero CAS:
Peso molecolare:
490.62
Codice UNSPSC:
41116107
NACRES:
NA.24

Grado

certified reference material
pharmaceutical secondary standard

Livello qualitativo

agenzia

traceable to BP 1144
traceable to Ph. Eur. Y0000515
traceable to USP 1292303

Famiglia di API

glimepiride

CdA

current certificate can be downloaded

Confezionamento

pkg of 1 g

tecniche

HPLC: suitable
gas chromatography (GC): suitable

applicazioni

pharmaceutical (small molecule)

Formato

neat

Temperatura di conservazione

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)
WIGIZIANZCJQQY-UHFFFAOYSA-N

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Descrizione generale

Glimepiride is an antidiabetic drug that belongs to the class of sulfonylureas. It is commonly used in the treatment of type-2 diabetes mellitus.
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.

Applicazioni

Glimepiride may be used as a pharmaceutical reference standard for the determination of the analyte in bulk drug and pharmaceutical formulations by high performance liquid chromatography.
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.

Risultati analitici

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

Altre note

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.

Nota a piè di pagina

To see an example of a Certificate of Analysis for this material enter LRAb7813 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Pittogrammi

Health hazard

Avvertenze

Warning

Indicazioni di pericolo

Classi di pericolo

Repr. 2

Codice della classe di stoccaggio

11 - Combustible Solids

Classe di pericolosità dell'acqua (WGK)

WGK 3

Punto d’infiammabilità (°F)

Not applicable

Punto d’infiammabilità (°C)

Not applicable


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Certificati d'analisi (COA)

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Reversed phase HPLC method for determination of glimepiride in tablet dosage form
Wanjari DB and Gaikwad NJ
Indian Journal of Pharmaceutical Sciences, 67(2), 253-253 (2005)
Glimepiride
USP42/NF37: United States Pharmacopeia and National Formulary
United States Pharmacopeia/National Formulary, 42(6)(6), 2062-2062 (2018)
Simultaneous estimation of metformin hydrochloride, pioglitazone hydrochloride, and glimepiride by RP-HPLC in tablet formulation.
Jain D, et al.
Journal of Chromatographic Science, 46(6), 501-504 (2008)
R K Campbell
The Annals of pharmacotherapy, 32(10), 1044-1052 (1998-10-30)
To review the clinical pharmacology data regarding the sulfonylurea glimepiride, and to summarize the clinical trials of glimepiride efficacy and safety alone and in combination with insulin for the treatment of type 2 diabetes mellitus. A MEDLINE database search (English

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