Variasi: | Other |
---|---|
Komponen: | Kimia Synthetic Drugs |
Tipe: | Other |
Faktor-faktor yang berpengaruh dalam Farmakodinamik: | Other |
Metode Penyimpanan: | Mencegah melebihi periode Jaminan Kualitas |
Veteriner Tidak.: | Other |
Pemasok dengan izin usaha terverifikasi
Items | Standard | Result |
Characters and Solubility | A white or almost white,crystalline powder .Freely soluble in water and sparingly soluble in methanol | Complies |
Identification | 1.IR | Complies |
2.Chemical reaction | ||
Crystallinity | meets the requirements | pass |
Specific optical rotation | +58°~ +64° | +63° |
Assay | 916~964 ug/mg (on anhydrous acid basis) | 954ug/mg |
Loss on drying | ≤3.0% | 1.50% |
pH | 4.5~6.5 | 5 |
Clarity and color of solution | Clear | Clear |
max0.20(430nm) | 0.07 | |
Foreign matter | 10um:≤6000 | 493 |
25um:≤600 | 3 | |
Related substance | Any peak :≤1.0% | 0.50% |
Total Peak:≤3.0% | 1.2% | |
Bacterial endotoxin | less than 0.20EU/mg | Complies |
Sterility | sterile | Complies |
Pemasok dengan izin usaha terverifikasi