EP Standard
EP Standard
| item | specification |
|---|---|
| Appearance | White or almost white, hygroscopic powder. |
| Identification | (A) infrared absorption (2.2.24) (B) gives reaction (b) of sodium (2.3.1) (C) the principal band in the electropherogram obtained with the test solution is similar in position to that obtained with reference solution (a) |
| pH (2.2.3) | 5.5~7.5 |
| Specific optical rotation (2.2.7) | -20 °~ -30.0 ° |
| Intrinsic viscosity | 0.01 m3/kg ~ 0.15 m3/kg |
| "Related substance Electrophoresis (2.2.31)" | Any individual impurity: not more than 2% |
| "Protein (2.5.33，Method 2)" | not more than 3.0% |
| Chlorides (2.4.4) | not more than 5.0% |
| Heavy metals (2.4.8) | not more than 20 ppm |
| Loss on drying (2.2.32) | not more than 12.0% |
| Microbial contamination | Total viable aerobic count (2.6.12) not more than 103 micro-organisms per gram. It complies with the tests for Staphylococus aureus, Pseudomonas aeruginosa, Escherichia coli, Salmonella and Enterobacteria and certain other gram-negative bacteria (2.6.13). |
| Residual solvent | Ethanol: not more than 0.5% |
| Assay | 95% ~ 105% |
Copyright © 2008 - 2010
鲁ICP备12033505号-1
Shandong Zhongyuan Greentech Co., Ltd Copyright
鲁ICP备12033505号-1
鲁公网安备 37012602000139号
Shandong Zhongyuan Greentech Co., Ltd Copyright