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