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Merck

PHR1287

Supelco

Glyburide (Glibenclamide)

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

Glybenclamide, 5-Chloro-N-[4-(cyclohexylureidosulfonyl)phenethyl]-2-methoxybenzamide, Glyburide, N-p-[2-(5-Chloro-2-methoxybenzamido)ethyl]benzenesulfonyl-N′-cyclohexylurea

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About This Item

Fórmula empírica (notación de Hill):
C23H28ClN3O5S
Número de CAS:
Peso molecular:
494.00
EC Number:
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

agency

traceable to BP 175
traceable to Ph. Eur. G0325000
traceable to USP 1295505

API family

glyburide, glibenclamide

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

COc1ccc(Cl)cc1C(=O)NCCc2ccc(cc2)S(=O)(=O)NC(=O)NC3CCCCC3

InChI

1S/C23H28ClN3O5S/c1-32-21-12-9-17(24)15-20(21)22(28)25-14-13-16-7-10-19(11-8-16)33(30,31)27-23(29)26-18-5-3-2-4-6-18/h7-12,15,18H,2-6,13-14H2,1H3,(H,25,28)(H2,26,27,29)

InChI key

ZNNLBTZKUZBEKO-UHFFFAOYSA-N

Gene Information

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General description

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.
Glyburide (Glibenclamide) is a potent second-generation sulfonylurea widely utilized as an anti-diabetic drug, typically against type 2 diabetes. Its mode of action majorly involves the stimulation of endogenous insulin release from beta cells of pancreas.

Application

Glyburide (Glibenclamide) may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and plasma samples 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 (PhEur) 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 LRAC3255 in the slot below. This is an example certificate only and may not be the lot that you receive.

hcodes

Hazard Classifications

Aquatic Chronic 4

Storage Class

11 - Combustible Solids

wgk_germany

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable


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Certificados de análisis (COA)

Lot/Batch Number

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Visite la Librería de documentos

Detection of phenformin and glyburide illegally mixed into traditional Chinese medicine antidiabetic preparations by the liquid chromatography-mass spectrometry method [J]
Yu D, et al.
Journal of Shenyang Pharmaceutical University, 1 (2005)
Simultaneous assay of metformin and glibenclamide in human plasma based on extraction-less sample preparation procedure and LC/(APCI) MS
Georgita C, et al.
Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 854(1-2), 211-218 (2007)
Application of liquid chromatography atmospheric pressure chemical ionization tandem mass spectrometry in the quantitative analysis of glyburide (glibenclamide) in human plasma
Ramos L, et al.
Rapid Communications in Mass Spectrometry, 13(24), 2439-2443 (1999)
A validated high-performance liquid chromatographic method for the determination of glibenclamide in human plasma and its application to pharmacokinetic studies
Niopas I, et al.
Journal of Pharmaceutical and Biomedical Analysis, 28(3-4), 653-657 (2002)
George E Dailey
Expert opinion on pharmacotherapy, 4(8), 1417-1430 (2003-07-25)
Oral antidiabetic combination therapy is a proven means of establishing glycaemic control in the hyperglycaemic, Type 2 diabetic patient, but co-administering two oral antidiabetic agents separately may hinder compliance with therapy. A new single-tablet of glyburide/metformin combination therapy (Glucovance), Bristol-Myers

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