Paclitaxel

Description:
Test    Standard    Results
Appearance    White to off-whitecrystalline powder    White crystalline powder
Identification    Infrared Absorption     Conform
   HPLC    Conform
Solubility    Insoluble in water, soluble I alcohol.    Conform
Assay    Not less than 97.0 bercen1. and not more than102.0 percent of calculated on the anhydrous, solvent free badis.    99.5%
Water    NMT 4.0%    0.96%
Specific Rotation    -49.0~ -55.0(at 20)    -49.4
Residue on Ignition    NMT 0.2%    0.12%
Heavy Metals    NMT 0.002%    NMT 0.002%


Microbial limits    Total aerobic microbialNMT 100cfu/g.
Absence of Staphaureusn aureus,
Pseudomonas aeruginos, Salmonella species,
and Escherichia coli.    Conform
Bacterial endotoxins    0.4EU/mg    0.2EU/mg




Related  Compounds











Related  Compounds    Baccatin                  NMT0.2%    Conform
   Cephalomannine             NMT 0.5%    0.05%

   10-Deacetyl-7-epipaclitaxel (paclitaxcl related compound B)                NMT 0.5%    
0.121%
   Sum of cephalomannine (paclitaxcl related compoundA)and2,3-Dihydrocephalomannine;                         NMT 0.5%    Conform
   7-Xylosypaclitaxel;           NMT0.2%    0.13%
   10-Deacetylpaclitaxcl;         NMT0.5%    Conform
   Sum of Benzyl analog3 and34Dehydropaclitaxel C;        NMT0.5%    Conform
   7-Epipaclitaxel              NMT 0.5%
Other                      NMT 0.1%
Total impurities              NMT 2.0%    0.127%
NMT 0.1%
NMT 0.55%





Residue Solvents    Dichloromethane           NMT 100ppm
Chloroform               NMT 50ppm
Acetonitrile               NMT 410ppm
Ethyl acetate              NMT 5000ppm
Methanol                 NMT 3000ppm
Acetone                  NMT 5000ppm    Conform
Conform
Conform
Conform
Conform
Absence
Conclusion:  Conforms with the repuirements of  U.S.P 30-NF 25 page 2844

Place of Origin:	China(Mainland)
Price Terms :	FOB