|
Test
|
Standard
|
Results
|
|
Appearance
|
White to off-white??/span>crystalline 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??/span>)
|
-49.4°
|
|
Residue on Ignition
|
NMT 0.2%
|
0.12%
|
|
Heavy Metals
|
NMT 0.002%
|
NMT 0.002%
|
|
Microbial limits
|
Total aerobic microbial??/span>NMT 100cfu/g.
Absence of Staphaureusn aureus,
Pseudomonas aeruginos, Salmonella species,
and Escherichia coli.
|
Conform
|
|
Bacterial endotoxins
|
≤0.4EU/mg
|
??/span>0.2EU/mg
|
|
Related Compounds
Related Compounds
|
Baccatin??/span> 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 and3”??/span>4”Dehydropaclitaxel 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
|