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Test	Standard	Results
Appearance	White to off-white，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℃)	-49.4°
Residue on Ignition	NMT 0.2%	0.12%
Heavy Metals	NMT 0.002%	NMT 0.002%
Microbial limits	Total aerobic microbial：NMT 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	BaccatinⅢ                  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”，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

Paclitaxel

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

Docetaxel
[Product type]: pharmaceutical raw material
[English name]: Docetaxel
[Molecular formula]: C43H53NO14
[Molecular weight]: 807.88
[ C A S ]: 114977-28-5
[Quality standard]: Enterprise Standard
[ Content]: ≥99.0%
[ Appearance]: White powder
[Function and use]: The mechanism strengthens the microtubule protein polymerization and suppresses depolimerization causing stable non-functionality and thus destructing cell's mitosis.
[Usage]: Pharmaceutical raw material, be for preparation's using only
[Packing]: 200g/tin, 100g/tin
[ Storage]: Shade, airtight and cold place.