
|
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 |