中文
Amiodarone Hydrochloride
CAS Number: 19774-82-4
Molecular Formula: C25H29I2NO3·HCl;C25H30ClI2
Standard: BP2010/EP6
Package: 25kg/drum
Amiodarone Hydrochloride
CAS Number: 19774-82-4
Molecular Formula: C25H29I2NO3·HCl;C25H30ClI2
Standard: BP2010/EP6
Package: 25kg/drum
| ITEMS | LIMIT |
| 1.appearance | White or almost white,fine crystalline powder |
| 2.solubility | |
| water | Very slightly soluble |
| methanol | Soluble |
| methylene chloride | Freely soluble |
| ethanol | Sparingly soluble |
| identification | |
| infrared absorpion | positive |
| chlorides | positive |
| appearance of solution | Clear and NMT GY5 or BY3 |
| ph | 3.2-3.8 |
| related substances(hplc) | |
| total impurity(%) | ≤0.5 |
| any impurity(%) | ≤0.2 |
| impurity h (tlc)(%) | ≤0.02 |
| iodides(%) | ≤0.015 |
| heavy metals(ppm) | ≤20 |
| loss on drying(%) | ≤0.5 |
| sulphated ash(%) | ≤0.1 |
| Assay(%) | 98.5-101.0 |