Erlotinib intermediates manufacturer

2-Amino-4,5-bis(2-methoxyethoxy)benzonitrile
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Sodium Erythorbate

Inspect Item

Specification

Results

Appearance

White crystalline powder or granules

Conform

Identification

Passes Test A,B,C

Conform

Assay  %

98.0~100.5

99.09

Specific Rtation  [a]25D

+95.5°~+98.0°

96.30°

PH Value

5.5~8.0

7.4

Lead  mg/kg

5 max

1.0

Loss on drying  %

0.25 max

0.11

Oxalate

Passes Test

Conform

 

Conclusion

Conform

Basis of Analysis:FCC(VI) Standard of USA and Client’s Requirements

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