Items |
Specification |
Method |
Appearance |
Light Yellow Crystalline Powder |
Organoleptic |
Identification |
Meets The Requirements |
HPLC |
Melting Point |
60-62ºC |
USP |
Specific Rotation |
-1.0°to +1.0° |
USP |
Loss On Drying |
≤0.20% |
USP |
Residue On Ignition |
≤0.10% |
USP |
Heavy Metals |
≤10ppm |
USP |
Lead |
≤3ppm |
USP |
Cadmium |
≤1ppm |
USP |
Mercury |
≤0.1ppm |
USP |
Chromatographic Purity |
||
Single Impurity |
≤0.10% |
HPLC |
Total Impurities |
≤2.0% |
HPLC |
Residual Solvent By GC |
||
Cyclohexane |
≤1000ppm |
GC |
Ethyl Acetate |
≤250ppm |
GC |
Toluene |
≤20ppm |
GC |
Microbiology |
||
Total Plate Counts |
≤1000cfu/g |
USP |
Moulds And Yeasts |
≤100cfu/g |
USP |
E.Coli And Salmonella |
Absence/g |
USP |
Staphylococcus Aureus |
Absence/g |
USP |
Particle Size |
100% Through 20 Mesh |
USP |
Assay |
98.5%-101.0% |
HPLC |