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PHR1288

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Gliclazide

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Gliclazide, N-[[(hexahydrocylopenta[c]pyrrol-2(1H)-yl)amino]carbony]-4-methylbenzene sulfonamide
CAS Number:
EC Number:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to BP 368
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

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)

InChI key

BOVGTQGAOIONJV-UHFFFAOYSA-N

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PHR1617PHR1813PHR1632
Gliclazide Pharmaceutical Secondary Standard; Certified Reference Material

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PHR1288

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technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

format

neat

format

neat

format

neat

format

neat

storage temp.

2-8°C

storage temp.

2-30°C

storage temp.

2-30°C

storage temp.

2-8°C

Quality Level

300

Quality Level

300

Quality Level

300

Quality Level

300

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, 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 LRAC3531 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Exclamation mark

Signal Word

Warning

Hazard Statements

Precautionary Statements

Hazard Classifications

Acute Tox. 4 Oral

Storage Class Code

11 - Combustible Solids

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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Sigma-Aldrich

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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)
Rajendra Awasthi et al.
Current drug delivery, 9(5), 437-451 (2012-08-28)
The objective of present project was to improve the dissolution profile of gliclazide by developing floating alginate beads using various biodegradable polymers like gelatin, pectin and hydroxypropylmethylcellulose (HPMC). The floating beads were prepared by a simple ionotropic gelatin method using
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
P C Lim et al.
The Medical journal of Malaysia, 67(1), 21-24 (2012-05-16)
Type-2 diabetes mellitus (T2DM) patients who were on gliclazide co-administered with metformin were changed to pre-combined glibenclamide-metformin tablets in the Endocrine Clinic, Penang Hospital. We conducted a retrospective study to evaluate the differences in glycaemic control and treatment cost following

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