Manufacturer Supply API 99% Purity Pharmaceutical Intermediate Gliclazide

• Powder: Yes
• Customized: Non-Customized
• Certification: GMP, ISO 9001, USP, BP
• Suitable for: Adult
• State: Solid
• Purity: >99%
• Model NO.: Gliclazide
• CAS Number: 21187-98-4
• Common Name: Gliclazide
• Appearance: White Powder
• Assay: 100%
• Loss on Drying: 0.11%
• Heavy Metals: <10ppm
• Transport Package: Bag, Drum
• Specification: 25kg/drum
• Trademark: Arshine
• Origin: China
• HS Code: 2935900090
• Production Capacity: 200 Tons/Year

Product Description

Manufacturer Supply API 99% Purity Pharmaceutical Intermediate Gliclazide

Gliclazide is a 2nd generation oral sulfonylurea hypoglycemic agent with strong action. Its mechanism is similar to that of toluenosulfonylurea, i.e., it selectively acts on pancreatic β-cells to promote insulin secretion and enhance insulin release after eating glucose, which can not only improve the metabolism of diabetic patients, but also improve or delay the occurrence of diabetic vascular complications.
Gliclazide is mainly used for mild and moderate type II diabetes mellitus with adult-onset where diet and exercise control alone are ineffective and without a tendency to ketosis, and also improves fundus lesions and metabolic and vascular dysfunctions in diabetic patients.

Test	Specifications	Results of analysis
Appearance	White or almost white powder.	White powder
Solubility	Practically insoluble in water; freely soluble in methylene chloride; sparingly soluble in acetone; slightly soluble in ethanol(96 percent).	Meets the requirements
Identifications	The infrared absorption spectrum is concordant with that obtained with gliclazide CRS.	Meets the requirements
Impurity B (By HPLC)	≤2ppm	0.5ppm
Heavy metals	≤10ppm	<10ppm
Related substances (By HPLC)	Impurity F ≤0.1%	Non-detected
	Each unspecified impurity ≤0.10%	0.04%
	Sum of impurities other than F ≤0.2%	0.11%
Loss on drying	≤0.25%	0.11%
Sulfated ash	≤0.1%	0.03%
Residual solvents (By GC)	Ethyl acetate NMT 2500 ppm	265ppm
	N,N-Dimethylformamide NMT 880 ppm	Non-detected
Assay	99.0-101.0%, on dried basis.	100.0%