Appearnce: white to almost white powder |
|
Specific rotation : +290-315o ( anhydrous substance) | |
Sulphated ash: no more than 1.0% |
|
Water (karl Fisher): 11.5-14.5% | |
Assay (HPLC anhydrous): 95.0-100.5% |
|
Potency (anhydrous basis): 950-1005 mcg/mg |
|
Dimethylaniline: N.M.T 20 ppm | |
Bulk density: 0.55-0.75 g/cc |
|
Related substance: Total: N.M.T 5.0% Individual: N.M.T 1.0% |
|
Identification: Positive by IR or NIR |
Crystallinity: crystalline |
Clarity of solution: HCL: N.M.T slightly opalescent NH3: N.M.T slightly opalescent |
pH: 3.5-5.5 |
Solubility: Water: slightly soluble |