|
Items |
Specification |
|
Appearance: |
White or off-white crystalline powder. |
|
Identification: UV Absorption |
Complies |
|
Water (by KF) |
Not more than 1.0% |
|
Arsenic |
Not more than 2ppm |
|
Heavy metals |
Not more than 5ppm |
|
Specific rotation: |
-48 to -52 |
|
Melting point: |
215-217 Celsius degree |
|
Impurities:
Cephalomannine
10-Deacetyl-7-Epi-Taxol
7-Epi-Taxol
Individual Unknown:
Total Unknown:
Total Impurities |
Not more than 0.5%
Not more than 0.5%
Not more than 0.5%
Not more than 0.1%
Not more than 0.5%
Not more than 1.0% |
|
Organic Volatile Impurities:
Chloroform
Methylene Chloride
Petroleum Ether
Ethanol
Acetone
Ethyl Acetate |
Not more than 60ppm
Not more than 100ppm
Not more than 100ppm
Not more than 100ppm
Not more than 100ppm
Not more than 100ppm |
|
Assay (by HPLC): |
Not less than 99.5% |