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PHR1287

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Glyburide (Glibenclamide)

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Glybenclamide, 5-Chloro-N-[4-(cyclohexylureidosulfonyl)phenethyl]-2-methoxybenzamide, Glyburide, N-p-[2-(5-Chloro-2-methoxybenzamido)ethyl]benzenesulfonyl-N′-cyclohexylurea
Empirical Formula (Hill Notation):
C23H28ClN3O5S
CAS Number:
10238-21-8
Molecular Weight:
494.00
EC Number:
233-570-6
MDL number:
MFCD00056625
UNSPSC Code:
41116107
PubChem Substance ID:
329823281
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

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

human ... ABCC8(6833) , KCNJ11(3767)

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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.

related product

Product No.
Description
Pricing

G0325010

Glibenclamide impurity A, European Pharmacopoeia (EP) Reference Standard

Y0000242

Glibenclamide impurity B, European Pharmacopoeia (EP) Reference Standard

Y0001511

Glibenclamide for peak identification, European Pharmacopoeia (EP) Reference Standard

1295505

Glyburide, United States Pharmacopeia (USP) Reference Standard

1295516

Glyburide Related Compound A, United States Pharmacopeia (USP) Reference Standard

1295527

Glyburide Related Compound B, United States Pharmacopeia (USP) Reference Standard

BP237

Methyl N-4-[2-(5-chloro-2-methoxybenzamido)ethyl]benzenesulfonylcarbamate, British Pharmacopoeia (BP) Reference Standard

BP071

4-[2-(5-Chloro-2-methoxybenzamido)ethyl]benzenesulfonamide, British Pharmacopoeia (BP) Reference Standard

PHR2414

Glyburide Related Compound A, Pharmaceutical Secondary Standard; Certified Reference Material

Hazard Statements

H413

Precautionary Statements

P273 - P501

Hazard Classifications

Aquatic Chronic 4

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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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)
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)
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)
Alfredo Juárez-Saldivar et al.
International journal of molecular sciences, 21(12) (2020-06-21)
Chagas disease, caused by Trypanosoma cruzi (T. cruzi), affects nearly eight million people worldwide. There are currently only limited treatment options, which cause several side effects and have drug resistance. Thus, there is a great need for a novel, improved
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