Penicillin G Benzathine Fortified

Benzylpenicillin mixturebuffered, sterile mixture
Penicillin G Benzathine/Procaine/Potassium; 6:3:3

Penicillin G Benzathine:

Molecular formula:
2(C16H18N2O4S).C16H20N2.4H2O
Molecular weight:
981.2

Penicillin G Procaine:

Molecular formula:
C16H18N2O4S.C13H20N2O2.H2O
Molecular weight:
588.7

Penicillin G Potassium:

Molecular formula:
C16H17N2O4S.K
Molecular weight:
372.5
 Benzathine Fortified

Application

This mixture, which contains approx. 0.85 % of sodium citrate buffer and suspending agents, can be filled into vials using any customary filling machine without adding any excipients. A homogeneous suspension for injection is prepared by adding water for injection and shaking briefly.

Antibiotic category

Favorable combination of depot penicillin and short-acting penicillin; blood levels up to one week

Packaging

Storage

Store below 25°C,
Protect from light and moisture

Shelf life

48 months

Specification

Appearancewhite to cream-colored, crystalline powder
Injection testcorresponding (needle diameter: not more than 400 µm)
Water content
(Karl Fischer)		not more than 6.0 %
pH-value6.0 - 7.5
Sterility
(USP/Ph.Eur.)		sterile
Bacterial endotoxins
(LAL-test/USP)		not more than 0.010 EU/100 IU
Assay/Content
  • Penicillin G (HPLC):
    1130 - 1250 IU/mg
  • Penicillin G Procaine:
    283 - 312 IU/mg
  • Penicillin G Benzathine:
    565 - 625 IU/mg

Pharmacopoeial quality

The active substances correspond to USP, BP, Ph.Eur.