Test  Item

Analysis  Specification

Result

Description

A slightly yellowish or white power

A slightly yellowish  power

Identification

UV spectrum according to Ph.Eur.7.0

TLC according to Ph.Eur.7.0

Colorimetric test according to Ph.Eur.7.0

Conform

Solubility

Slightly soluble I water, freely soluble in acetone in ethanol(96%)and in methanol

Conform

pH

8.5~10.5

10.0

Specific optical rotation

-85°~ -80°

-82°

Related Substances

Impurity A  ≤2.0%

Impurity B  ≤2.0%

Impurity D  ≤2.0%

Impurity E  ≤2.0%

Impurity F  ≤2.0%

Impurity G  ≤2.0%

Impurity H  ≤2.0%

Any other impurity  ≤2.0%

Total impurities ≤10.0%

0.1%

1.0%

1.2%

Not detected

1.6%

0.1%

Not detected

0.12,0.19%

0.26,0.37%

4.5%

Conforms

Loss on drying

≤3.5%

0.9%

Sulphated ash

Not more than 0.1%

0.06%

Heavy metals

≤20ppm

<20ppm

Butyl acetate

≤5000ppm

30ppm

Composition

SpiramycinⅠ:not less than80.0%

SpiramycinⅡ: not more than5.0%

Spiramycin Ⅲ: not more than10.0%

Total SpiramycinⅠ,Ⅱ,Ⅲ: not less than90.0%

95.8%

0.2%

0.3%

96.3%

Assay

Not less than 4100iu/mg calculated with reference to the substances

4892iu/mg

Conclusion

The above certificate of analysis is in compliance with Ph.Eur.7.0