| ≥1 piece |
|
Items of Analysis
|
Specification
|
Results
|
|||
|
Assay (by HPLC)
|
97% to 102%
|
99.54%
|
|||
|
Identification
|
IR
|
Concordant With R.S.
|
Conform
|
||
|
HPLC
|
Concordant With R.S.
|
Conform
|
|||
|
Heavy Metals
|
0.002%max
|
Conform
|
|||
|
Appearance
|
Fine powder
|
Conform
|
|||
|
Colour
|
White
|
Conform
|
|||
|
Odor
|
Characteristic
|
Conform
|
|||
|
Melting Point
|
213 to 217
|
213
|
|||
|
Specific Rotation
|
-49 to -55
|
-51
|
|||
|
Water
|
4.0%max
|
0.49%
|
|||
|
Residue on Ignition
|
0.2%max
|
0.10%
|
|||
|
Related
Substances
|
2-Debenzoylpaclitaxel
-2-pentenoate
|
0.7%max
|
0.11%
|
||
|
10-Deacetylpaclitaxel
|
0.5%max
|
0.10%
|
|||
|
7-Acetylaclitaxel
|
0.6%max
|
0.007%
|
|||
|
others
|
0.1% each max
|
conform
|
|||
|
organic Volatile Impurities
|
Meet the requirements
|
Conform
|
|||
|
Microbial
|
Microbial Limits
|
100cfu/g max
|
Conform
|
||
|
Bacterial Endotoxins
|
0.4EU/mg max
|
Conform
|
|||