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Merck

PHR1288

Gliclazide

Pharmaceutical Secondary Standard; Certified Reference Material

Sinónimos:

Gliclazide, N-[[(hexahydrocylopenta[c]pyrrol-2(1H)-yl)amino]carbony]-4-methylbenzene sulfonamide

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Número CAS:
21187-98-4
UNSPSC Code:
41116107
EC Number:
244-260-5
NACRES:
NA.24

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SMILES string

[S](=O)(=O)(NC(=O)NN2CC3C(C2)CCC3)c1ccc(cc1)C

InChI key

BOVGTQGAOIONJV-UHFFFAOYSA-N

InChI

1S/C15H21N3O3S/c1-11-5-7-14(8-6-11)22(20,21)17-15(19)16-18-9-12-3-2-4-13(12)10-18/h5-8,12-13H,2-4,9-10H2,1H3,(H2,16,17,19)

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. G0326000

API family

gliclazide

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

Quality Level

300

Categorías relacionadas

General description

Gliclazide is an orally administered antidiabetic medication used in the treatment of type 2 diabetes mellitus, mainly for elderly patients.
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

Gliclazide may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using spectrophotometric technique and spectrofluorimetric technique.
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 and EP 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.
To see an example of a Certificate of Analysis for this material enter LRAC3531 in the slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Exclamation mark
GHS07

signalword

Warning

hcodes

H302

Hazard Classifications

Acute Tox. 4 Oral

Clase de almacenamiento

11 - Combustible Solids

wgk

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificados de análisis (COA)

Busque Certificados de análisis (COA) introduciendo el número de lote del producto. Los números de lote se encuentran en la etiqueta del producto después de las palabras «Lot» o «Batch»

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Spectrophotometric determination of gliclazide in pharmaceuticals and biological fluids through ternary complex formation with eosin and palladium (II)
El-Enany N
Il Farmaco (Societa Chimica Italiana : 1989), 59(1), 63-69 (2004)
Spectrofluorimetric and spectrophotometric determination of gliclazide in pharmaceuticals by derivatization with 4-chloro-7-nitrobenzo-2-oxa-1, 3-diazole
El-Enany N
Journal of AOAC (Association of Official Analytical Chemists) International, 86(2), 209-214 (2003)
M V Shestakova
Vestnik Rossiiskoi akademii meditsinskikh nauk, (1)(1), 45-49 (2012-05-04)
Diabetic nephropathy (DN)--is a leading cause of terminal renal failure in the developed countries. Kidney pathology development undergoes several stages--from preclinical structural changes in the first years of the disease to diffuse or nodular glomerulosclerosis 15-20 years after the diabetes
Vipulkumar D Prajapati et al.
International journal of biological macromolecules, 55, 6-14 (2013-01-12)
Modified release biological macromolecules (beads) of gliclazide using sodium alginate combined with either gellan gum or pectin in different ratios were prepared by Ionotropic gelation method. Biological macromolecules were evaluated for different physico-chemical parameters. Increase in polymers proportion showed difficulty
K Adibkia et al.
Drug research, 63(2), 94-97 (2013-02-22)
Gliclazide is practically insoluble in water and its GI absorption is limited by its dissolution rate. Our previously published works indicated that preparing gliclazide-crosspovidone solid dispersion in the drug/ carrier ratio of 1:1 using cogrinding technique is able to enhance
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