Penicillin V Benzathine

Benzathine Phenoxymethylpenicillinmicrofine, oral

Molecular Formula:
2(C16H18N2O5S).C16H20N2.4H2O
Molecular Weight:
1013.2
CAS registry no.:
63690-57-3
 Benzathine

Application

Microfine powder used in the manufacture of all oral dosage forms.

Category

Oral penicillin

Packaging

Storage

Store below 25°C,
Protect from light and moisture

Shelf life

48 months

Specification

Appearancewhite to whitish, crystalline powder
Particle size
(mass distribution, image analysis)		x(50,3): 5 - 9 µm
80 %: 3 - 20 µm
exceeding 125 µm:
not more than 0.5 %
Water content
(Karl Fischer)		5.0 - 8.0 %
pH-value4.0 - 6.5
Sulfated ashnot more than 0.2 %
Assay
  • Penicillin V Benzathine (HPLC):
    1060 - 1240 IU/mg
  • Penicillin V (HPLC):
    62.3 - 72.5 %
    67.0 - 76.0 % 1)
  • Benzathine (HPLC):
    23.0 - 26.0 % 1)
1) Based on the anhydrous substance

Pharmacopoeial quality

USP