Specifications
Items | Standards | Results | Method |
Appearance | White crystalline fine powder | Conforms | Visual |
Sulfate | ≤0.05% | 0.06% | USP |
Odor | Characteristic | Conforms | Organoleptic |
Heavy metals | ≤10ppm | Conforms | AAS |
Melting point | 194ºC-202ºC | 196.4ºC-198.4ºC | USP |
Residue on Ignition | ≤0.1% | 0.05% | 75ºC/5hrs |
Related subtances | ≤0.5% | 0.34% | HPLC |
Loss on drying | ≤0.5% | 0.26% | 105ºC/3hrs |
Ph value | 2.3-2.7 | 2.47 | USP |
Iron | <60ppm | Conforms | AAS |
Lead | <1ppm | Conforms | AAS |
Casmium | <1ppm | Conforms | AAS |
E.coli | Negative | Conforms | CP2005 |
Yeast & Mold | <100cfu/g | 25cfu/g | CP2005 |
Salmonella | Negative | Conforms | CP2005 |
Total plate count | <1000cfu/g | 80cfu/g | CP2005 |
Assay phenibut | ≥99.0% | 99.31% | HPLC |
Usage
Considering the history of alopecia areata drug development, rituximab is the second mature drug for the treatment of alopecia areata. It is a kinase inhibitor. Unlike the first drug Olumiant, rituximab is approved not only for adult patients, but also for adolescent patients aged 12 years and above.