Paclitaxel

ASSAY （HPLC）

97.0%～102.0% (calculated on the anhydrous, solvent-free basis)

99.88%

SPECIFIC ROTATION

-49.0°～-55.0°

-54.6°

Identification

IR:Infrared Absorption:In accordance with the reference Standard spectrum of paclitaxel

Conforms

HPLC:The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.

Conforms

RELATED COMPOUNDS

  (HPLC)

10-Deacetylbaccatin Ⅲ≤0.1%  

N.D.

Baccatin III≤0.2%

N.D.

Photodegradant≤0.1%

N.D.

10-Deacetylpaclitaxel≤T 0.5%

N.D.

2-Debenzoylpaclitaxel-2-pentenoate  ≤ 0.7%

N.D.

Oxetane ring opened, acetyl and benzoyl migrated≤ 0.4%

N.D.

10-Acetoacetylpaclitaxel≤ 0.4%

N.D.

10-Deacetyl-7-epipaclitaxel≤0.4%

N.D.

7-Epipaclitaxel≤ 0.4%

032%

10,13-Bissidechainpaclitaxel≤0.5%

N.D.

7-Acetylpaclitaxel≤0.6%

N.D.

13-Tes-baccatin III≤ 0.1%

N.D.

7-Tes-paclitaxel  ≤0.3%

N.D.

Others≤ 0.1% (each)

N.D.

Total≤2.0%

0.032%

ORGANIC VOLATILE IMPURITIE

Acetone≤5000ppm

360ppm

n-heptane≤ 5000ppm

180ppm

Dichloromethane≤600ppm

N.D.

Ethanol≤ 5000ppm

N.D.

WATER

≤ 4.0%

0.86%

CONCLUSION: The product is in accordance with USP43 to test the above-mentioned items, the test results conform to the specification.