Product Brief Introduction
Product name: Abacavir Sulfate
CAS： 188062-50-2
MF: C28H38N12O6S
MW: 670.74
Product Specification
|
Item |
Specification |
|
Appearance |
White to off-white powder |
|
Identification |
HPLC(Referred to isomer): The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the Enantiomeric purity. |
|
IR: The infrared absorption spectrum of the sample complies with the reference standard. |
|
|
Sulfate identification: Meets the standard |
|
|
Solubility |
Soluble in water,practically insoluble in Ethanol (96%) and in methylene chloride |
|
Moisture |
≤ 0.5% |
|
Residue on Ignition |
≤ 0.2% |
|
Specific Rotation |
-58.0°~ -54.0° |
|
Related Substances |
Impurity A (Enantiomeric Purity) ≤ 0.3% |
|
Impurity B (O-Pyrimidine Derivative Abacavir) ≤ 0.2% |
|
|
Impurity C (Descyclopropyl Abacavir) ≤ 0.2% |
|
|
Impurity D (Trans-Abacavir) ≤ 0.2% |
|
|
Impurity F (t-Butyl derivative Abacavir) ≤ 0.2% |
|
|
Impurity 3 (Disubstituted impurity) ≤ 0.1% |
|
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Single maximum unspecified impurity ≤ 0.1% |
|
|
Total impurities ≤ 0.8% |
|
|
Heavy Metals |
≤ 20ppm |
|
Residual Solvent |
Methanol ≤ 3000ppm |
|
Ethanol ≤ 5000ppm |
|
|
Isobutanol ≤ 5000ppm |
|
|
Benzene ≤ 2ppm |
|
|
Total Plate Count |
≤ 1000cfu/g |
|
Yeasts&Molds |
≤ 100cfu/g |
|
E.Coli |
Negative/g |
|
Assay (HPLC) (on dried basis) |
97.0%-102.0% |
