Appearance: White to yellowish powder Specific rotation :+60.5°~ +63.0° Solubility Sparingly :soluble in water,soluble in alcoho…
Appearance: White to yellowish powder
Specific rotation :+60.5°~ +63.0°
Solubility Sparingly :soluble in water,soluble in alcohol.
Melting point: About 125℃
Identification:
A:IR absorption spectrum:
Corresponds to the IR spectrum of Zidovudine
RS
B: HPLC
Corresponds to the retention time of major
peak in the chromatogram of the standard preparation.
Water: ≤1.0%
Residue on ignition :≤0.25%
Test A (TLC):Sum of all impurities ≤3.0%
Test B(HPLC):Zidovudine related compound B :≤1.0%
Zidovudine related compound C :≤2.0%
Sum of all impurities(A+B) :≤3.0%
Tapped density :0.55~0.7g/ml
Bulk density :<0.45g/ml
Residual solvents:
Methanol: ≤0.2%
Triethylamine: ≤0.02%
Ethyl acetate:≤0.2%
Dioxane:≤0.02%
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