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FLUDARABINE PHOSPHATE
Chemical name: 9-bata-D-Arabinofuranosyl-2-fluoroadenine phosphate
CAS: 75607-67-9
Molecular formula: C10H13FN5O7P
Molecular weight: 365.21
Structural formula:
Specification:
| Items |
Specification |
Product standard |
EP5.4 |
Description |
white crystalline powder |
Specific rotation |
+10.0°- +14.0° |
Microbial limits |
=1000cfu/g |
Limit of free phosphate |
=0.1% |
Limit of sodium |
=0.2% |
Water |
=3.0% |
Individual impurities |
Iso-ara-guanine-monophosphate=0.8%(w/w) 0.4%
Isoguanine =0.2%(w/w)
3',5'-Diphosphate analog =0.4%(w/w)
2-Fluoroadenine =0.1%(w/w)
2-Fluoro-ara-adenine =0.2%(w/w)
2-Ethoxyphosphate analog =0.2%(w/w) |
Residue solvents |
DMF=0.0020%
Methylene chloride=0.0020%
Ethanol=1.0% |
Chloride |
=.2% |
Ethanol |
= 1.0% |
Related substances |
Single substance: =0.2% |
Other substances:= 0.5% |
Heavy metals |
=20ppm |
Any other impurity
Sum of all other impurities
Sum of all impurities |
=0.1%
=0.5%
=1.5% |
Assay(HPLC) |
98.0%-102.0% |
Use |
Antineoplastic API |
Fludarabine base
Chemical Name: 9-ß-D-Arabinofuranosyl-2-fluoroadenine
CAS NO.: 21679-14-1 (phosphate: 75607-67-9)
Molecular Formula: C10H12FN5O4
Molecular Weight285.23
Structural Formula
| Tests |
Specification |
Product standard |
EP5.4 |
Description |
White or off-white powder, odorless |
Water |
=3.0% |
Chloride |
=.2% |
Ethanol |
= 1.0% |
Related substances |
Single substance: =0.2% |
Other substances:= 0.5% |
Heavy metals |
=20ppm |
Assay(HPLC) |
98.0%-102.0% |
Use |
Intermediate of fludarabine |
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