Solubility 溶解性

在水中易溶，在乙醇中溶解，乙醚和苯中不溶  Very soluble in water, soluble in alcohol, insoluble in ether and in benzene

符合規(guī)定

Complies

鑒別 Identification

A.紅外應(yīng)與對(duì)照品一致

By IR, should be corresponds to the standard solution.

符合規(guī)定

Complies

B. 應(yīng)顯氯化物的鑒別反應(yīng)

Should identify significant chloride reaction

符合規(guī)定

Complies

C. 含量測(cè)定項(xiàng)下，樣品中主峰的保留時(shí)間與對(duì)照品 一致

The retention time of the major peak of the sample solution corresponds to that of the Standard solution, as obtained in tha Assay.

符合規(guī)定

Complies

Heavy metal

重金屬

≤10ppm

Complies

符合規(guī)定

Residue on ignition 熾灼殘?jiān)?/span>

≤ 0.1%

0.06%

Related Substances 有關(guān)物質(zhì)

Aminobenzoic acid ≤ 0.4%

Related compound B  ≤ 0.4% 

Related compound C  ≤ 0.4%

Individual unspecified impurity ≤ 0.4%

Total impurity ≤ 0.8%

Not detected

0.044%

0.024%

0.054%

0.32%

水分 Water

≤2.0%

0.10%

熔點(diǎn)    Melting range

About 148℃

148℃～149℃

殘留溶劑 Residual Solvents

乙醇 Ethanol≤0.5%

0.043%

丙酮 Acetone≤0.5%

未檢出Not detected

甲苯 Toluine ≤ 0.089%

未檢出Not detected

含量 Assay

98.0～102.0%

99.62%

結(jié)論 Conclusion

The Sample Complies With Specification of USP43