high quality Paclitaxel powder

Items

Specifications

Results

Description

White to off-white powder

White to off-white powder

Identification:

A: Infrared Absorption (IR) 

B: The retention time  (HPLC) 

Conforms to reference spectrum

Conforms to the chromatogram of the 

Standard preparation

Conforms

Conforms

Specific rotation  á 

(on the anhydrous, solvent-free basis)

-49.0° to   -55.0°

-51.17°

Microbial limits 

The total aerobic microbial

Staphylococcus aureus ,

 Pseudomonas aeruginosa, 

Salmonella species and Escherichia coli.  

≤100 CFU/g

meets the requirements of the tests for the absence

Not found

Not found

Bacterial endotoxins 

≤0.4 USP Endotoxin Unit per mg

Complies

Water

≤4.0%

0.62%

Residue on Ignition

≤0.2%

0.09%

Heavy Metals 

≤0.002%

<0.001%

Related compounds

Baccatin III 

≤0.2%

Less than LOD (0.003%)

10-Deacetylpaclitaxel 

≤0.5%

Less than LOD (0.003%)

7-Xylosylpaclitaxel 

≤0.2%

Less than LOD (0.003%)

Cephalomannine 

2¢¢,3¢¢-Dihydrocephalomannine

a1

a2         a1+ a2 ≤0.5 %

0.11%

10-Deacetyl-7-epipaclitaxel  

≤0.5%

Less than LOD (0.003%)

Benzyl analog3 

3¢¢,4¢¢-Dehydropaclitaxel C

b1

b2         b1+ b2 ≤0.5 %

Less than LOD (0.003%)

7-Epicephalomannine 

≤0.3%

Less than LOD (0.003%)

7-Epipaclitaxel 

≤0.5%

0.04%

Any Other single impurity

≤0.1%

0.01%,0.006%,0.03%,0.006%,0.04%

(RRT=1.24,1.26,1.31,1.41,1.44)

Total impurities

≤2.0%

0.24%

Organic Volatile Impurities (OVI)

Meets current USP requirement

Meets current USP requirement

Assay (on the anhydrous, solvent-free basis) 

97.0%~102.0%

100.48%

Residual Solvents

  Acetone

≤2000ppm

52ppm

  Dichloromethane 

≤100ppm

20ppm

  Ethyl acetate

≤1000ppm

71ppm

Cyclohexane

≤1000ppm

712ppm

Conclusion:   The product Complies with the requirement of USP29