ITEMS | STANDARD |
Purity % | 98.0%-102.0% |
Identification | A. IR spectrum obtained with sample corresponds to that obtained with reference. |
B. The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay. | |
C. GC: Positive | |
DMSO Content | ≤ 0.1 |
Appearance | White Crystalline Powder |
Odor | Odorless |
Melting Point ºC | 108.5-110.5 |
Bulk Density | ≥0.65 |
Mesh size | 60-80MESH |
Water Content | 0.10%Max |
Heavy Metal(as bp)s : PPM | 3ppmMax |
Any Other Individual Impurity | ≤ 0.05% |
Total Impurity | ≤ 0.20% |
Residual Solvents | Free |
Residue on Ignition% | <0.10 |
Coliform(CFU/g) | Negative |
E.Coli(CFU/g) | Negative |
Yeast/Mold(CFU/g) | <10 |
Salmonella | Negative |
Standard Aerobic Plate Count(CFU/g) | <10 |
Solubility | Freely soluble in water, in methanol, in alcohol, and in acetone. Sparingly soluble in ether. |