法莫替丁 Famotidine
76824-35-6
为白色至淡黄白色结晶粉末 White to pale yellowish-white crystalline powder
有关物质 Related substances 总杂质 Total impurities≤1.0%
干燥失重 Loss on drying ≤0.5%
炽灼残渣 Residue on ignition ≤0.1%
重金属 Heavy metals ≤10ppm
残留溶剂 Residual solvent 乙醇 Ethanol≤0.5% 丙酮 Acetone≤0.5%
含量 Assay 98.5~101.0%
结论 Conclusion 本品符合 USP42/EP9 质量标准 Complies with USP42/EP9 standard
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