Penicillin G Procaine

Procaine Benzylpenicillin1 % lec., semimicrofine, sterile

Molecular formula:
C16H18N2O4S.C13H20N2O2.H2O
Molecular weight:
588.7
CAS registry no.:
6130-64-9
 Procaine

Application

Mainly used for the manufacture of powders for injections (vials). The product can be filled into vials using any customary filling machine. A homogeneous solution is prepared by adding water for injection and shaking briefly.

Antibiotic category

One-day depot penicillin

Packaging

Storage

Store below 25°C,
Protect from light and moisture

Shelf life

60 months

Specification

Appearancewhite to whitish, crystalline powder
Specific optical rotation+165° to +180° 1)
Particle size
(mass distribution, image analysis)		x(50,3): 9 -16 µm
80 %: 2 - 48 µm
exceeding 50 µm:
not more than 10 %
exceeding 125 µm:
not more than 0.5 %
Injection testcorresponding (needle diameter: not more than 300 µm)
Water content
(Karl Fischer)		2.8 - 4.2 %
pH-value5.0 - 7.5
Sterility
(USP/Ph.Eur.)		sterile
Bacterial endotoxins
(LAL-test/USP)		not more than 0.010 EU/100 IU
Related substances
(HPLC)		individually: not more than 1.0 %
Assay/Content
  • Penicillin G Procaine (HPLC):
    96.0 - 102.0 % 1)
  • Penicillin G (HPLC):
    900 - 1050 USP-U/mg
    51.0 - 59.6
    55.7 - 60.5 % 1)
  • Procaine (HPLC):
    37.5 - 43.0 %
    39.0 - 42.0 % 1)
  • Lecithin (HPTLC):
    0.5 - 1.5 %
1) Based on the anhydrous substance

Pharmacopoeial quality

The active substance corresponds to USP, BP, Ph.Eur.