ITEMS
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STANDARDS
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RESULTS
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Appearance
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White or slightly yellowish-white hygoscopic powder
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Slightly yellowish-white hygoscopic powder
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Solubility
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Very soluble to freely soluble in water, and freely soluble in anhydrous ethanol, practically insoluble in heptane.
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Complies
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Identification
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Infrared absorption spectrum is identical to that of rebeprazole sodium reference standard.
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Complies
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It gives reaction (a) of sodium
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Complies
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pH
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9.5-11.5
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10.5
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Related substances
(HPLC)
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Impurity A: NMT 0.8%
|
0.05%
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Unspecified impurities: NMT 0.10%
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0.09%
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Total impurities: NMT 1.0%
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0.28%
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Related substances
(GC)
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Methylene chloride: NMT 600ppm
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<LOD(LOD=62ppm)
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Ethanol: NMT5000ppm
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<LOD(LOD=62ppm)
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Isopropyl ether: NMT5000ppm
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10ppm
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Acetone: NMT5000ppm
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26ppm
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Assay
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97.0%-102.0%, calculated on the dried basis
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100.6%
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Microbial limit
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Total aerobic microbial count ≤ 1000cfu/g
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< 10cfu/g
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Total combined yeasts and molds count ≤ 100cfu/g
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< 10cfu/g
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Escherichia coli: absence in 1g
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Complies
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Conclusion
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Complies with the requirements of EP8.7
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