Grade: Pharmaceutical Grade

Factory Location: Hunan

Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa

Sample Provided: no

GMP Gliclazide pharmaceutical raw materials/21187-98-4/Gliclazide powder /gliclazide made in China : 

1.USP/BP/EP 
2.offer the Documents (GMP, DMF ,COA and so on) 
3.Place of origin:china

gliclazide specification

Items	Acceptable criteria	Results
Characteristics	A white or almost white powder	A white powder
Solubility	Practically insoluble in water: freely soluble in methylene chloride; Sparingly soluble in acetone(96%); slightly soluble in alcohol (96%)	Conforms
M.P	162-166°C	164.0-164.5°C
Identification	Conform to the spectrum of the CRS Gliclazide	Conforms
Heavy metals	≤10ppm	<10ppm
Impurity B	≤2ppm	0.3ppm
Related substances	Impurity F ≤0.10%	<0.10%
	Other single impurity ≤0.10%	<0.10%
	Total of other impurities ≤0.2%	0.13%
Loss on drying	≤0.25%	0.1%
Sulphated ash	≤0.1%	0.01%
Residual solvents	Ethyl acetate ≤0.5%	Below LOQ
	Toluene ≤0.089%	Below LOQ
Assay (on dried basis)	99.0%-101.0%	99.5%
Conclusion	The test results conform with EP7.0/BP2009/CP2010

 

Storage:

kept in a light-proof,well-colsed,dry and cool place.

Packaging & Shipping

25kg/fiber drum, or 25kg/carton 

MOQ: 1 DRUM

delivery time: 7-15 days after payment.

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Certifications: 

• GMP
• COS