Paclitaxel CAS 33069-62-4 MSDS
Batch Number: 08shop II Analysis Date: 5th MAY, 2009
Batch Quantity: 1900Gs Certificate Date: 5th MAY, 2009
Manufacture Date: 3rd MAY, 2009 Expire Date: 2nd MAY 2013
|
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 |
|
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|
|
|
|
Conclusion Conforms to the USP28-NF23 Specification.
Storage Store in cool and dry places, keep away from strong direct light |