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PHR1617

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Glimepiride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

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

Empirical Formula (Hill Notation):
C24H34N4O5S
CAS Number:
93479-97-1
Molecular Weight:
490.62
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

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

API family

glimepiride

CofA

current certificate can be downloaded

packaging

pkg of 1 g

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)

InChI key

WIGIZIANZCJQQY-UHFFFAOYSA-N

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General description

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.

Application

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.

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 LRAb7813 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

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

Y0000516

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

Y0000515

Glimepiride, European Pharmacopoeia (EP) Reference Standard

1292314

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

1292336

Glimepiride Related Compound C, United States Pharmacopeia (USP) Reference Standard

1292347

Glimepiride Related Compound D, United States Pharmacopeia (USP) Reference Standard

Y0001742

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

PHR1727

Glimepiride Related Compound C, Pharmaceutical Secondary Standard; Certified Reference Material

PHR1725

Glimepiride cis-Isomer (Glimepiride Related Compound A), Pharmaceutical Secondary Standard; Certified Reference Material

BP1144

Glimepiride, British Pharmacopoeia (BP) Reference Standard

PHR1726

Glimepiride Sulfonamide, pharmaceutical secondary standard, certified reference material

Pictograms

Health hazard
GHS08

Signal Word

Warning

Hazard Statements

H361

Hazard Classifications

Repr. 2

Storage Class Code

11 - Combustible Solids

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
LRAC2892
LRAB7813
LRAA4876
LRAC2892
LRAB7813

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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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