ZXFPC0248 Gliclazide

CAS Number: 21187-98-4

Gliclazide

Appearance: White or almost white powder

Quality Index Standard Results

Identification: Rule of BP98 Conforms
Heavy metals: ≤10ppm <10ppm
3-Nitroso-3-azabicyclo[3.3.0]octane: ≤2ppm <2ppm
Related substances:
1-(3-abicyclo[3.3.0]oct-3-yl)-3-o-tolylsulphonylurea:≤0.1％ 0.03%
Other single impurity (max): ≤0.1％ 0.02%
Other total impurities (max): ≤0.2％ 0.08%
Loss on drying: ≤0.25％ 0.09%
Sulphated ash: ≤0.1％ 0.04%
Assay: 99.0-101.0% 99.66%

Conclusion: The Specification conforms to the rule of BP98.

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