Appearance: White or almost white crystalline powder Identincation: A:IR comparison didanosine CRS B:HPLC Should meet the requi…
Appearance: White or almost white crystalline powder
Identincation:
A:IR comparison didanosine CRS
B:HPLC Should meet the requirement
Water(K.F): ≤2.0%
Residue on ignition :≤0.2%
Heavy Metals :≤20ppm
Specific rotation :-24.0°∽-28.0°(anhydrous)
Related compounds:
Hypoxanthine≤0.5%
Inosine≤0.2%
2’-Deoxyinosine≤0.3%
3’-Deoxyinosine≤0.2%
2’,3’-anhydroinosine≤0.2%
Dideoxydidehydroinosine≤0.2%
2’,3’-dideoxyadenosine≤0.2%
5’-Deoxydideoxyadenosine≤0.2%
Any other impurity ≤0.1%
total≤1.0%
Assay (on the anhydrous basis) :98.0%~102.0%
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