Penicillin G Procaine

Procaine Benzylpenicillin1 % lec., microfine, sterile

Molecular Formula:
C16H18N2O4S.C13H20N2O2.H2O
Molecular Weight:
588.7
CAS registry no.:
6130-64-9
 Procaine

Application

Mainly used for the manufacture of ready-for-use aqueous suspensions for injection. Due to the optimized particle size of the material a homogeneous, agglomerate-free, and physically stable suspension is obtained by mixing the substance into water using an agitator. In order to improve the wettability and suspendibility the material is coated with lecithin.

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): 6 - 12 µm
80 %: 3 - 25 µm
exceeding 50 µm:
not more than 3 %
exceeding 125 µm:
not more than 0.5 %
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
Largest impurity
(Ph.Eur./HPLC)		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.