1538-09-6 BENZYLPENICILLIN BENZATHINE with EP9 STERILE
Items |
Specifications |
Characters (Ph.Eur.) |
White or almost white powder |
Identification(IR) (Ph.Eur.) |
IR spectrum complies with that of reference standard(IR) |
Acidity or Alkalinity (Ph.Eur.) |
≤0.2ml |
Related Substances(HPLC) (Ph.Eur.) |
Impurity C: Not more than twice the sum of the areas of the 2 principal peaks (2%) Any other impurity: Not more than the sum of the areas of the 2 principal peaks (1%) |
Water (Karl Fischer) (Ph.Eur.) |
5.0 ~ 8.0% |
N’N-Dibenzylethylenediamine Benzathine (HPLC) (Ph.Eur.) |
24.0 ~ 27.0% (Calculated with reference to the anhydrous substance) |
Benzathine Benzylpenicillin (HPLC) (Ph.Eur.) |
96.0 ~ 102.0 % (Calculated with reference to the anhydrous substance) |
Lecithin |
1% |
Bacterial Endotoxins (Ph.Eur.) |
<0.13 IU/ml |
Sterility (Ph.Eur.) |
Sterile |
Residual Solvents (GC) (Ph.Eur.) Ethanol Ethyl Acetate |
≤5000ppm ≤5000ppm |