Audited Supplier
Ibrutinib
Anti-Viral
GMP, FDA, ISO
Medicine Grade
Chemicals
Solid
Not Volatile
White to off-White Solid Powder
More Than 99%
Sjar-Tech
Cardboard Drums or Cartons
gram, kilogram
China
2934999099
Product Description
| Items | Standards | Results |
| Appearance | White to off-white solid powder | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| Solubility | Freely soluble in Tetrahydrofuran; soluble in Methanol, Dichloromethane and Acetonitrile, slightly soluble in Toluene, and practically insoluble in water. | Complies |
| Loss on Drying | ≤ 0.50% | 0.15% |
| Heavy Metal | ≤ 10ppm | Complies |
| Residue on Ignition | ≤ 0.10% | 0.08% |
| Residual Solvent | Tetrahydrofuran: ≤ 720ppm | 90ppm |
| Methylbenzene: ≤ 890ppm | ND | |
| Methanol: ≤ 3000ppm | 180ppm | |
| Dichloromethane: ≤ 600ppm | ND | |
| Ethyl Acetate: ≤ 5000ppm | 580ppm | |
| Related Substances | Any single impurity: ≤0.10% | 0.08% |
| Total Impurities: ≤0.50% | 0.35% | |
| Assay | 99.0%~101.0% on anhydrous basis | 99.82% |
| Reference Standard | In-house Standard | |
| Conclusion | The product complied to In-house standard. | |
| Storage | Preserve in tight,light-resistant containers in a cool place | |
