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Gliclazide

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

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 common markets for this product include the following countries. Please inquire with us if your country or region is not listed:

Asia: Afghanistan, Israel, Jordan, Pakistan, Russia, Saudi Arabia, Singapore, Syria, Philippines, Turkey, Turkmenistan, Uzbekistan, Yemen, Vietnam, Indonesia, Malaysia, Iran, Tajikistan, etc.

Africa: South Africa, Uganda, Nigeria, Ghana, Kenya, Mauritius, Botswana, Egypt, Ethiopia, Libya, Sudan, Congo, Gambia, Ivory Coast , etc.

North & South America: USA, Canada, Panama, Trinidad and Tobago, Costa Rica, Puerto Rico, Dominican Republic, Argentina, Guatemala, Guyana, Peru, Bolivia, Venezuela , Brazil, Bahamas, Ecuador, etc .

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, etc.

OCEANIA: Australia, New Zealand, Fiji, etc.

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