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Paclitaxel (Natural) USP30
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Fludarabine phosphate
 
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   
   

 
:::Fludarabine phosphate:::
Product Information
Product Name Fludarabine phosphate

Molecular Formula

C10H13FN5O7P(365.21)

Cas No.

75607-67-9

Analysis

Standard

Assay (by dried substance)

98.0~102.0%

Physical Control

Appearance

White or almost white powder

Identification(by IR and HPLC)

Conforms

Specific optical rotation

+10º~+14º

Water(K.F.)

NMT3.0%

Chemical Control

Chloride

NMT 0.2%

Free phosphate

NMT 0.1%

Ethanol

Not more than 0.5%

Limit of Sodium

Not more than 0.2%

Heavy metals

Less than 20ppm

Microbial limits

The total aerobic microbial count shall not exceed 1000cfu/gm

Chromatographic Impurities

Relative Impurities

NMT1.5%

Iso-ara-guanine-monophosphate

≤0.8%

Isoguanine

≤0.2%

3’,5’-Diphosphate

≤0.4%

2-Fluoroadenine

≤0.1%

2-Fluoro-ara-adenine

≤0.2%

2-Ethoxyphosphate analog

≤0.2%

Other individual impurity

≤0.1%

Storage

Cold storage in well closed containers and protect from light and moisture.






 

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