Gliclazide

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:

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.