Product name

Paclitaxel

Molecular Weight

Batch No.

2020.05.10

Certificate No.

Manu.date

May 10,2020

Expiry

May 09,2022

Molecular Formular

C₄₇H₅₁NO₁₄

Quantity

500g

Text Item

Specifications

Results

Appearance

White to Off-white crystalline powder

conform

Solubility

Solube in alcohol,methanol,chloroform,hardly

Solube in water

conform

Specific optical rotation

-48^o～-54^o

-52.2^o

moisture

≤4.0%

0.44%

Identification

A: IR spectrum of the sample preparation should be identical to that of to the standard sample

conform

B: The 0.002% w/v solution in methanol exhibits manima 283,275,230nm

positive

Chioride

≤0.1%

conform

Purity(HPLC)

≥99%

99.8%

Related substances

A:Single Impurity ≤0.3%

0.03%

B:Total Impurities ≤1.0%

0.20%

Residue of ignition

≤0.2%

0.02%

Residual solvents

Meet the requirement of ICH

conform

Heavy metals

≤20ppm

conform

Assay

98%～102%

99.8%

Conclusion

The above product conforms to USP38