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PHR1288

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Gliclazide

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

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

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About This Item

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

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

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

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
GHS07

Signal Word

Warning

Hazard Statements

H302

Precautionary Statements

P264 - P270 - P301 + P312 - P501

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

Choose from one of the most recent versions:

Certificates of Analysis (COA)

Lot/Batch Number
LRAC9797
LRAC3531
LRAA9085
LRAA0301

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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
Georgia Ragia et al.
Diabetes research and clinical practice, 98(1), 119-124 (2012-05-18)
In addition to sulfonylurea-induced severe hypoglycemia, which however is not common in T2DM patients treated solely with oral hypoglycemic drugs, mild hypoglycemia is a frequent adverse event affecting many patients treated with oral hypoglycemic drugs and has a serious impact
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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