China Rocuronium Bromide Intermediate, Rocuronium Impurity Reference Standard, Find details about China Rocuronium, Rocuronium Bromide from Rocuronium Bromide Intermediate, Rocuronium Impurity Reference Standard
| Product name/CAS | Rocuronium Bromide/119302-91-9 | ||
| Batch No | 191206 | Batch Qty | 3.28kg |
| MFG. Date | 2019.12.06 | Report Date | 2019.12.08 |
| Ref. Standard | USP41 | EXP. Date | 2021.12.05 |
| Items | Specifications | Results | |
| Description | Almost white or pale yellow, slightly pink, slightly hygroscopic crystalline powder | Almost white or pale yellow | |
| Solubility | Freely soluble in water and in anhydrous ethanol | Complies | |
| Identification | (1)IR Spectrum conforms with RS | Complies | |
| (2)gives reaction of bromides | Complies | ||
| Appearance of solution | Dissolve 0.10 g in carbon dioxide-free water R and dilute to 10 ml with the same solvent. Solution is clear | Complies | |
| Solution is not more intensely colored than reference solution | Complies | ||
| pH | 7.0~9.5 | 9.18 | |
| Specific optical rotation | + 28.5°~ + 32.0° | +29.6° | |
| Related substances | individual known impurities A≤0.2%;(B, C)≤0.3%;(D, E, F, G, H)≤0.1% | A0.02%;C:0.05%; F: 0.08%; D,E,H,B,G: not found(≤0.05%); | |
| Individual unknown impurity ≤0.1% | Complies | ||
| Total impurities ≤1.5% | <0.5%, Complies | ||
| Chlorides | ≤0.1% | 0.06% | |
| Residual solvents | Methylene chloride ≤600ppm | 90ppm | |
| Methanol≤3000ppm | 560ppm | ||
| Ethyl ether ≤5000ppm | ≤30ppm | ||
| MTBE ≤5000ppm | 60ppm | ||
| Ethyl acetate≤5000ppm | ≤30ppm | ||
| Elemental Impurities | (Cd,Pb,As,Hg,Co,V,Ni,Li,Sb)≤0.5ppm,Cu≤2.5ppm | Complies | |
| Water | ≤4.0% | 2.99% | |
| Sulphated ash | ≤0.1% | 0.03% | |
| Endotoxins | ≤7EU/mg | <1EU/mg | |
| Assay | 98.0%~102.0% | 99.7% | |
| Conclusion | The material complies to specifications given above | ||