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:::Paclitaxel (Natural) USP34:::

Product Information
Product Name Paclitaxel (Natural) USP34

Molecular Formula

C47H51NO14 (853.9)

Cas No.

33069-62-4

Quality standard

complies with USP34

Analysis Standard
Assay (W/W) 97.0- 102.0%

Paclitaxel (HPLC)

NLT99.5%

Physical Control

Appearance

White crystalline powder

Identification (By IR)

Complies

Identification (By HPLC)

Complies

Specific Optical Rotation

-49.0°~-55.0°

Water

NMT4.0%

Chemical Control

Residue of solvents

Complies with ICH requirement

Residue on Ignition

NMT0.2%

Bacteria Endotoxins

NMT0.4USP EU/mg

Heavy Metal

NMT20ppm

Microbial Limits

NMT100cfu/g

Impurity

Total Impurities

NMT 0.5%

Individual Impurities

NMT 0.1%

Baccatin Ⅲ

NMT0.2%

10-Deacetylpaclitaxel

NMT0.5%

7-Xylosylpaclitaxel

NMT0.2%

Cephalomannine and 2,3-Dihydrocephalomannine

NMT0.5%

10-deacetyl-7-epi-paclitaxel

NMT0.5%

Benzyl analog and 3,4-Dehydropaclitaxel C

NMT0.5%

7-Epicephalomannine

NMT0.3%

7-epi-paclitaxel

NMT0.5%

Other Individual Impurities

NMT0.1%

Storage

Store in well closed containers and perfect from light and moisture.


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