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Paclitaxel

Function

  1. Pharmaceutical intermediates
  2. Antitumor
  3. Phytochemicals
  4. Herbal medicine

Product Name: Paclitaxel
Assay :99%
Appearance: White crystalline powder
CAS No.: 33069-62-4
Specification: 98%
Molecular Formula: C47H51NO14
Molecular Weight: 853.92

    CERTIFICATE OF ANALYSIS

Product name
Paclitaxel
CAS No.
114977-28-5
Outer Packing
10g\50g\100g
Production date
2017.03.18
Shelf life
2019.03.17
Standard adopted
EP7.5
Items of analysis
Specification
Results
APPEARANCE
Conforms
IDENTIFICATION
Infrared Absorption:In accordance with the reference Standard spectrum of paclitaxel
Conforms
SPECIFIC ROTATION
-41.5°~-38.5°
-39.2°
APPEARANCE OF SOLUTION
The solution is not more opalescent than reference suspension II(2.2.1)and not more intensely coloured than reference solution B5(2.2.2,method I )
Conforms
WATER
NMT 1.5%
0.66%
HEAVY METALS
NMT20ppm
Conforms
ASSAY
98.0%~ 102.0%
99.8%
BACTERIAL ENDOTOXINS
NMT 0.3 IU/mg
Conforms
ORGANIC VOLATILE IMPURITIES
Acetone NMT 5000ppm
1616 ppm
ORGANIC VOLATILE IMPURITIES
n-hexane NMT 290ppm
5 ppm
ORGANIC VOLATILE IMPURITIES
Dichloromethane NMT 600ppm
Conforms
APPEARANCE
Conforms
IDENTIFICATION
Infrared Absorption:In accordance with the reference Standard spectrum of paclitaxel
Conforms
SPECIFIC ROTATION
-41.5°~-38.5°
-39.2°
APPEARANCE OF SOLUTION
The solution is not more opalescent than reference suspension II(2.2.1)and not more intensely coloured than reference solution B5(2.2.2,method I )
Conforms
WATER
NMT 1.5%
0.66%
HEAVY METALS
NMT20ppm
Conforms
ASSAY
98.0%~ 102.0%
99.8%
BACTERIAL ENDOTOXINS
NMT 0.3 IU/mg
Conforms
ORGANIC VOLATILE IMPURITIES
Acetone NMT 5000ppm
1616 ppm
ORGANIC VOLATILE IMPURITIES
n-hexane NMT 290ppm
5 ppm
ORGANIC VOLATILE IMPURITIES
Dichloromethane NMT 600ppm
Conforms
Conclusion
Qualified

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