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Paclitaxel (Semi-synthetic)
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:::Paclitaxel (Semi-synthetic) USP34:::

Product Information
Product Name Paclitaxel (Semi-synthetic) 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

NMT0.5%

10-DAB Ⅲ

NMT0.1%

Baccatin Ⅲ

NMT0.2%

Photodegradant

NMT0.1%

10-Deacetylpaclitaxel

NMT0.5%

2-Debenzoylpaclitaxel-2-pentenoate

NMT0.7%

10-deacetyl-7-epi-paclitaxel

NMT0.4%

7-epi-paclitaxel

NMT0.4%

10,13-bissidechainpaclitaxel

NMT0.5%

7-Acetylpaclitaxel

NMT0.6%

13-tes-baccatin Ⅲ

NMT0.1%

7-tes-paclitaxel

NMT0.3%

Other Individual Impurities

NMT0.1%

Storage

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

 
 
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