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Henry Industry Co.,Ltd
[China]
Address:
Room 402,Building 20 DingAn Yuan Hangzhou, Zhejiang, China Hangzhou ZheJiang 310003 China
Phone:
86-135-88477542
Contact name:
Henry Fang , sales manager
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Henry Industry Co.,Ltd



 
Chemcials & Raw Pharmaceuticals

Paclitaxel

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Paclitaxel

Click to enlarge image


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


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