Naproxen
We have GMP.
Characteristics:A white or almost white, crystalline powder
[Identification:
A: Infrared Absorption
The infrared absorption spectrum is concordant with the reference spectrum
B: Ultraviolet Absorption
Absorptivities at 271nm,
calculated on the dried base,
do not differ by more than
[Specific rotation] :+83.0°to +89.5°
[Loss on drying] :≤0.5%
[Heavy metals] :≤0.002%
[Chromatographic purity] 1
Impurity D(in-house) :≤0.10%
Impurity E(in-house, Impurity C in EP) :≤0.10%
Any other impurity: ≤0.10%
Total impurities: ≤1.0%
[Organic residual solvent] 2
Toluene:NMT 45ppm
Methanol:NMT 50ppm
[Assay] (On dry basis)It contains C14H14O3:98.5% ~ 101.5%
It conforms to USP35.
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