Scientific Information
1.1 Intended use
Reference Standard for laboratory tests as prescribed in the European Pharmacopoeia only.
Established for use with the monograph(s): 20702, 0179, 1982, 0293.

1.2 Analytical information related to intended use
Chromatogram(s)/spectrum : see annex
The “as is” content is : 4000 IU per milligram for microbiological assay (for 0293 and 20702)
Spiramycin I: 82.8%, Spiramycin II: 0.2%, Spiramycin III:4.1% (for 0293)

1.3 Uncertainty of the assigned value, when applicable
The uncertainty of the assigned value is not stated since it is considered to be negligible in relation to the defined limits of the method-specific assays for which the reference standard is used. Please also refer to Ph. Eur. chapter 5.12.