Naproxen Sodium 26159-34-2 (S)-Naproxen Sodium Salt
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Name: Naproxen Sodium
Synonyms: (S)-6-Methoxy-alpha-methyl-2-naphthaleneacetic acid sodium salt
C.A.S NO. : 26159-34-2
Specification: 98.5% to 101.5%
Standard: EP/BP/USP
Molecular formula: C14H13NaO3
Characteristic: White to almost white crystalline powder
Solubility: Soluble in water, methanol; slightly soluble in ethanol
Melting point: 250-251℃
Boiling point: 403.9℃ at 760 mmHg
tem |
Specifications |
Results |
|
Appearance |
White to almost white crystalline powder |
Almost white crystalline |
|
Identification |
A. Infrared absorption |
The infrared absorption spectrum is concordant with the reference spectrum |
Conform |
B. Ultraviolet Absorption |
Absorptivities at 272nm, calculated on the dried base, do not differ by more than 3% |
<1% |
|
Specific rotation |
-17.0°to -15.3° |
-16.7° |
|
Loss on drying |
≤1.0% |
0.2% |
|
Heavy metals |
≤0.002% |
<0.002% |
|
Free Naproxen |
≤1.0% |
0.1% |
|
Related substances (HPLC) |
Impurity D(in-house) |
≤0.10% |
<0.01% |
Impurity E(in-house, Impurity C in EP) |
≤0.10% |
<0.01% |
|
Any other impurity |
≤0.10% |
<0.01% |
|
Total impurities |
≤0.5% |
<0.01% |
|
Residual Solvents |
Toluene |
≤50ppm |
<1ppm |
Methanol |
≤50ppm |
<12ppm |
|
Ethanol |
≤100ppm |
<8ppm |
|
[Assay] (On the dried basis) It contains C14H13NaO3 |
98.5% to 101.5% |
99.7% |
|
Conclusion |
The results conforms with USP35 standards |
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