检查项目

Test items

规格

Specifications

结果

Results

性状

Characters

白色或无色结晶性粉末，微溶于水，

易溶于乙醇（96%）微溶于氯仿

A white, crystalline powder or white or colourless, acicular crystals, slightly soluble in water, freely soluble in ethanol (96 per cent), sparingly soluble in methylene chloride.

符合规定

Complies

鉴别A

Identification A

熔点158 °C -161 °C

Melting point158 °C to 161 °C

160.3°C

鉴别B

Identification B

红外吸收图谱应与标准品图谱一致

The IR spectrum of sample complies with

 salicylic acid CRS

符合规定

Complies

外观

Appearance of solution

溶液应澄清

Solution is clear and colourless

溶液应澄清

Solution is clear and colourless

有关物质

Related substances

  4-羟基苯甲酸

   4-hydroxybenzoic acid

≤0.1%

0.03%

  4-羟基间苯二甲酸

  4-hydroxyisophthalic acid

≤0.05%

0.02%

苯酚

Phenol

≤0.02%

0.01%

其它杂质

Other impurities

≤0.05%

0%

总杂质

Total impurities

≤0.2%

0.06%

氯化物

Chloride

≤100ppm

NMT100ppm

＜100ppm

硫酸盐

Sulfate

≤200ppm

NMT200ppm

＜200ppm

重金属

Heavy metals

≤20ppm

NMT20ppm

＜20ppm

干燥失重

Loss on drying

≤0.5%

NMT0.5%

0.28%

硫酸盐灰分

Sulphated ash

≤0.1%

NMT0.1% 

0.06%

含量（以干品计）

Assay（dried substance）

含C₇H₆O₃为99.0%-100.5%

ContainsC₇H₆O₃99.0%-100.5%

99.6%

【结论】：

Conclusion

本品按《英国药典》2010检验。结果[ 符 ]合规定。

The product comply with the requirements of BP2010