Pipecuronium bromide
CAS No.: 52212-02-9
Product Name: Pipecuronium bromide
CAS#52212-02-9
Package: customize the packaging
Delivery time: in stock for prompt shipment.
Dangerous goods or not: Not
Country of origin: China
CAS#52212-02-9
Package: customize the packaging
Delivery time: in stock for prompt shipment.
Dangerous goods or not: Not
Country of origin: China
Description
Spec of Pipecuronium bromide :
| Items | Specification | Results |
| Appearance | White or almost white powder,odorless;easily deteriorate in the air and hygroscopic. | Conforms |
| easily soluble in water and ethanol,slightly soluble in chloroform,and insoluble in ether or acetone. | Conforms | |
| Specific rotation | +6.0°~+10.0° | +8.9 ° |
| Identification A | add silver nitrate test solution into the aqueous solution of this API,a pale yellow precipitate will be produced。 | Conforms |
| Identification B | In the chromatogram recorded in the assay,the retention time of the principal peak of the sample solution should be consistent with that of the reference solution | Conforms |
| Identification C | The infrared absorption pectrum of this product should be consistent with the spectrum of the reference substance. | Conforms |
| Acidity | 5.0～7.0 | 6.8 |
| Clarity and color of solution | The solution is clear and not more intensely coloured than standard solution BY7 orY7 | Conforms |
| Impurity A | Not more than 0.3%. | 0.06% |
| Impurity B | Not more than 0.3%. | Less than LOD(LOD=0.009%) |
| Impurity C | Not more than 0.15%. | Less than Disregard Limit (Disregard Limit=0.05%) |
| Impurity D | Not more than 0.15%. | Less than LOD(LOD=0.004%) |
| Impurity E | Not more than 0.3%. | Less than Disregard Limit (Disregard Limit=0.05%) |
| Other single impurity | Not more than 0.10%. | Less than Disregard Limit (Disregard Limit=0.05%) |
| Total Impurities | Not more than 1.5%. | 0.06% |
| Methanol | Not more than 0.3%. | Less than LOQ(LOQ=0.003%) |
| Acetone | Not more than 0.5%. | 0.14% |
| Acetonitrile | Not more than 0.041%. | Less than LOD(LOD=0.0005%) |
| Trichloromethane | Not more than 0.006%. | Less than LOD(LOD=0.0005%) |
| Dichloromethane | Not more than 0.06%. | 0.001% |
| Water content | Not more than 5.0%. | 1.4% |
| Heavy metal | Not more than 10ppm | Conforms |
| Bacterial endotoxin | Not more than 5.0EU/mg | ≤5.0EU/mg |
| Total Aerobic Microbial Count | Not more than 100cfu | ≤10cfu/g |
| Total Combined Mold and Yeast | Not more than 10cfu | ≤10cfu/g |
| Enterobacterias resistant to bile | Cannot be detected/g | Conforms |
| Assay | 98.0%~102.0%,calculated as anhydrous and solvent- free substances | 100.8% |
