Complaint
Name: Naproxen Sodium powder Cas 26159-34-2
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,; slightly soluble in ethanol
Melting point: 250-251ºC
Boiling point: 403.9ºC at 760 mmHg
Function and Application
Naproxen sodium is anti-inflammatory drug. It is suitable for relieving all kinds of mild to moderate pain,such as tooth extraction and other post-operative pain, primary dysmenorrhea and headache. Naproxen sodium can also be used to treat rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, Juvenilearthritis, tendinitis, bursitis and acute gouty arthritis. Naproxen sodium can relieve symptoms of swelling and limited activity in arthritis.
Item | 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 | Toluen | ≤50ppm | <1ppm |
Methano | ≤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 | ||
