Common Name of Material Glimepiride Batch No. 041024 Quantity 12kgs Packing 5kg/tin Manufacturing Date Oct.-24-2004 Basis of Quality Standard Enterprise Standard Expiry Date Oct.-24-2007
Analysis Items
Specification Limits
Analysis Results
Appearance :
white or almost whitecrystal
qualified
Solubility :
sparingly soluble in chloroform, slightly soluble in methanol and ethanol. Insoluble in water
qualified, Identification
HPLC :
similar to standard
qualified
UV :
similar to standard max.at 228nm
qualified
Loss on Drying :
not more than 0.5%
0.42%
Residue on Ignition:
not more than 0.2%
0.08%
Sulfate :
not more than0.04%
qualified
Heavy Metals :
not more than 20ppm
qualified
Related Impurities :
total impurities not more than 1.0%
0.47%
(HPLC) :
individual impurity not more than 0.5%
0.26%
methyl benzene :
not more than 0.04%
qualified
Assay :
not less than 98.5% on dried basic
99.37%
CAS No.: 93479-97-1
Conclusion:It complies with all the requirements of the Enterprise Standard.
