Pharmaceutical Raw Material
Production Specifications :
Description : White to almost white crystalline powder.
Identification : Positive.
Absorbance (450 nm) : Less than 0.5.
Solubility : Soluble in DMF.
pH : Between 2.0 to 3.0.
Water Content : Not more than 4.0%.
Specific rotations : Between -115o to -125o.
Residue on ignition : Not more than 0.5%.
Purity : Individual impurity: Not more than 0.8%.
Total impurities: Not more than 2.0%.
Bacterial Endotoxins : Not more than 0.05 EU/mg.
Sterility : Meet the requirements.
Assay : Not less than 98%.
Particle size : 90% smaller than 10 microns.
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