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Fludarabine Phosphate
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CERTIFICATE OF ANALYSIS

Name: Fludarabine phosphate CAS: 75607-67-9

Batch No: 040905

Quantity: 0.050kg MFG.Date: 2004.10.5

Re-Test Date: 2009.9

Items

Specifications

Results

01

Appearance

White or almost white,crystalline powder

White crystalline powder

02

ID

IR

Complies with the reference spectrum

Complies

UV

Complies with the reference spectrum

Complies

03

Specific Rotations

+10 。 - +14 。

Complies

04

Microbial limits

NMT1000cfu/g

Complies

05

Water

NMT3.0%

Complies

06

Chloride

NMT0.2%

Complies

07

Ethanol

NMT1.0%

Complies

08

Free phosphate

NMT0.1%

Complies

09

Sodium

NMT0.2%

Complies

10

Loss on drying

≤ 0.5%

0.12%

11

Impurity content

≤ 1.5%

0.1%

12

Heavy metal content

≤ 20ppm

Conform

13

Assay

98.0~102.0%

On basis fo anhydrous,solvent free basis

99.3.0%

Conclusion

The product meets the standards of Enterprise standard.

Analyst:

QC manager:

QA/QC manager:

Date: 2004.10.8

Date: 2004.10.8

Date: 2004.10.8

 

   
　 　Key Intermediate 　 　
　
Fludarabine Base           CAS: CAS:21679-14-1
 
9- ? -D-arubinofuranosyl-2-fluoro-9H-purin-6-amine
 
Molecular Structure:
 
 
 
 
 
 
 
 
 
 
Specifications:
 
Items Tested Specifications
Appearance White crystal powder
Purity% 98%MIN
Melting Point 253.5
255.0 °C
 
 

2-Fluoro-2',3',5'-tri-o-acetyladenosine(Fludarabine Intermediate)  

 CAS: 15811-32-2

 
Molecular Structure:
 
 
 
 
 
 
 
 
 
Specifications:
 
Items Tested Specifications
Appearance White crystal powder
Purity% 85%MIN
Melting Point 194
197 °C
 
2-Fluoroadenosine(Fludarabine Intermediate)          CAS: 146-78-1
 
Molecular Structure:
 
 
 
 
 
 
 
 
 
Specifications:
 
Items Tested Specifications
Appearance Off-white crystal powder
Purity 98%MIN
Melting Point 222~228°C
　 　
  Applications    
　 　 　 　
　 Packing &loading 　 　
　 　 　 　
　       This data is only for your information purposes and does not imply guarantee for a certain application. 　 　
　      If you need an indicative price to your country, please kindly advise the annual quantity needed, destination port and we will send you our soonest CNF(Cost + Freight) price. Your indication for a workable price level will sure speed up our fastest service for you 　 　
　

     We really need to get feed back from our customers in order to improve our performances.
Any information about quotations from competitors will be welcomed since we hope to work as a team with you.
Your kind help will be very much appreciated.

     Best regards from SHENZHEN , China

                                                       Mr. JEFFERY TSUI

 　 　
　 　 　 　
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