Spiramycin

Spiramycin Base
4100 iu/mg
25kg/drum
Product:
Spiramycin Base
Mfg Date:
Apr., 2010
Expiry Date:
Mar. 2013
Batch No.:
100430120M
Analysis Items:
Congealing point and Assay
Standard code:
EP2002

Items
Specification
Results
Characteristics
A slightly yellowish or white powder
Conform
Identification
(1)(2)(3)
Conform
PH
8.5 – 10.5
9.8
Specific optical rotation
-85° - -80°
-82°
Related substances
Largest impurity not more than 2.0%
1.5%
Loss on drying
≤3.5%
0.8%
Heavy metal
≤20ppm
Conform
Sulphated ash
Not more than 0.1%
0.06%
Composition
Spiramycin 1 : not less than 80.0%
91.7%
Spiramycin 2: not more than 5.0%
0.2%
Spiramycin 3: not more than 10.0%
0.8%
Total Spiramycin 1,2,3: not less than 90.0%
92.7%
Assay
Not less than 4100iu/mg calculated with reference to the anhydrous substances
4721 iu/mg
Conclusion:
The above certificate of analysis is in compliance with EP2002