Product Category

Gliclazide

  • Product Name : Gliclazide
  • Grade : IP / BP / USP
  • Therapeutic Category : Antidiabetic
  • CAS No : 21187-98-4
  • COA : Available
  • MSDS : Available
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Description

Description

Gliclazide is used for control of hyperglycemia in gliclazide-responsive diabetes mellitus of stable, mild, non-ketosis prone, type 2 diabetes. It is used when diabetes cannot be controlled by proper dietary management and exercise or when insulin therapy is not appropriate.

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 IP/BP

 Packaging details:

Packaging details: 25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum.
Storage: Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat
Shelf Life: 5 years if sealed and store away from direct sun light.

Additional Information

The most widely recognized markets for this item incorporate the accompanying nations. If you don’t mind ask with us if your nation or district isn’t recorded:

ASIA: Afghanistan, Israel, Jordan, Pakistan, Russia, Saudi Arabia, Singapore, Syria, Philippines, Turkey, Turkmenistan, Uzbekistan, Yemen, Vietnam, Indonesia, Malaysia, Iran, Tajikistan, and so forth.

AFRICA: South Africa, Uganda, Nigeria, Ghana, Kenya, Mauritius, Botswana, Egypt, Ethiopia, Libya, Sudan, Congo, Gambia, Ivory Coast , and so forth.

NORTH & SOUTH AMERICA: USA, Canada, Panama, Trinidad and Tobago, Costa Rica, Puerto Rico, Dominican Republic, Argentina, Guatemala, Guyana, Peru, Bolivia, Venezuela , Brazil, Bahamas, Ecuador, and so forth .

EUROPE: Austria , Azerbaijan, Belarus, Belgium, Cyprus, Czech Republic, Denmark, France, Georgia, Germany, Hungary, Ireland, Iceland, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, Ukraine, United Kingdom (UK) , Latvia, and so forth.

OCEANIA: Australia, New Zealand, Fiji, and so forth.