Product Name：Paclitaxel
Molecular Formula： C47H51NO14
Molecular Weight： 853.92
CAS Registry number： 33069-62-4
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Appearance
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white to off-white powder
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Specific optical rotation
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-49.0°~-55.0°
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UV maximum absorption wavelength
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λmax227nm±2nm
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IR
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IR chromatograph Conforms to the characteristic peak of RS.
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HPLC
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The retention time of the major peak in the chromatogram Conforms to the characteristic peak of RS.
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Microbial Limits
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Not more than 100cfu/g
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Bacterial endotoxins
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Not more than 0.4EU/mg
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Solubility
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Insoluble in water. Soluble in alcohol.
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Water
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Not more than 4.0%
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Heavy metals
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Not more than 20ppm
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Residue on ignition
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Not more than 0.2%
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Related compound(HPLC)
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10-Deacetyl baccatin Ⅲ[RRT:0.11]
Baccatin Ⅲ [RRT:0.20]
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Not more than 0.1%
Not more than 0.2%
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Photodegradant [RRT:0.47]
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Not more than 0.1%
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10-Debenzoylapaclitaxel [RRT:0.47]
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Not more than 0.5%
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2-Debenzoylapaclitaxel-2-pentenoate
[RRT:0.80]
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Not more than 0.7%
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Oxetane ring opened. acetyl and benzoyl xl[RRT:0.92]
10-Acetoacetylpaclitaxel x2[RRT:0.92]
10-Deacetyi-7-epipaclitaxel x3[RRT:0.94]
Sum of x1,x2,x3;0.4%max
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Not more than 0.4%
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7-Epipaclitaxel[RRT:1.45]
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Not more than 0.4%
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10,13-Bissidechainpaclitaxel[RRT:1.45]
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Not more than 0.5%
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7-Acetylpaclitaxel [RRT:1.54]
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Not more than 0.6%
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13-Tes-baccatin Ⅲ [RRT:1.8]
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Not more than 0.1%
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7-Tes-pacltaxel [RRT:2.14]
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Not more than 0.3%
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Any other single
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Not more than 0.1%
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Total
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Not more than 2.0%
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Assay (HPLC)
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97%~102.0%
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Residue solvents(GC)
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Methanol
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3000ppm max
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Acetlne
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5000 ppm max
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n-Heptane:
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5000ppm max
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n-Hexane:
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290ppm max
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Ethylacetate
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5000ppm max
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Dichloromethane
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600ppm max
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Pyridine
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200ppm max
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THF
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720ppm max
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>>Alphabetical order
