|
|
|
|
 |
|
 About Genexol > Information > Specification |
|
|
|
| Test |
Specification |
Method |
| Appearance |
White to white-yellowish,
practically odorless, powder |
Visual |
| Residue on Ignition |
Not more than 0.2% |
USP 26 |
| Heavy Metals |
NMT 0.002 |
USP 26 |
| Assay |
97 .0¡© 102.0% |
USP 26 |
| Related Compounds |
Total NMT 2.0% |
USP 26 |
| Baccatin III |
NMT 0.2% |
| 10-Deacetylpaclitaxel |
NMT 0.5% |
| 7-Xylosylpaclitaxel |
NMT 0.2% |
| Cephalomannine |
a1 1 |
| 2¡±,3¡±-Dihydrocephalomannine |
a1 1 |
| 10-Deacety-7-Epipaclitaxel |
NMT 0.5% |
| Benzyl Analog |
b1 2 |
| 3¡±4¡±-Dehydropaclitaxel C |
b1 2 |
| 7-Epicephalomannine |
NMT 0.3% |
| 7-Epipaclitaxel |
NMT 0.5% |
| Organic volatile Impurities |
|
USP 26 |
| Chloroform |
NMT 60 PPM |
| 1,4-Dioxane |
NMT 380 PPM |
| Methylene Chloride |
NMT 600 PPM |
| Trichloroethylene |
NMT 80 PPM |
| Methanol |
NMT 3000 PPM |
| Hexane 3 |
NMT 29 PPM |
| Water Content |
NMT 4.0% |
USP 26 |
| Bacterial Endotoxins |
NMT 0.4 EU/mg |
USP 26a |
| Microbial Limit |
NMT 100 CFU/g 3 |
USP 26 |
| Identitfication |
Idenfical to Standard |
USP 26 |
| Specific Rotation |
-49.0¢ª -55.0¢ª |
USP 26 |
|
|
 The sum of a1 and a2 is not more than 0.5%. |
| The sum of b1 and b2 is not more than 0.5%. |
It must meet the requirements of the tests for the absence of Staphylococcus
aureus, Pseudomonas aeruginosa, Salmonella species, and Escherichia coli.
Storage Condition Store at room temperature in desiccator. |
|
 |
|
|
|
|
|
|
|
|
|
|
