Spiramycin

Test  Item

Analysis  Specification

Result

Description

A slightly yellowish or white power

A slightly yellowish  power

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%

Loss on drying

≤3.5%

0.9%

Sulphated ash

Not more than 0.1%

0.06%

Heavy metals

≤20ppm

<20ppm

Butyl acetate

≤5000ppm

30ppm

Assay

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

4892iu/mg

Packaging details:

25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum.

Storage:

Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat

Shelf Life:

5 years if sealed and store away from direct sun light.