Penicillin G Procaine Fortified

Benzylpenicillin mixturebuffered, sterile mixturePenicillin G Procaine / Sodium; 3:1

Penicillin G Procaine:

Molecular Formula:
C16H18N2O4S.C13H20N2O2.H2O
Molecular Weight:
588.7

Penicillin G Sodium:

Molecular Formula:
C16H17N2O4S.Na
Molecular Weight:
356.4
 Procaine Fortified

Application

Sterile mixture of Penicillin G Procaine and Penicillin G Sodium, with approx. 7.7 % of sodium citrate buffer. The mixture can be filled into vials without adding any excipients. It complies with the BP-monograph "Fortified Procaine Penicillin Injection". A homogeneous solution is prepared by adding water for injection and shaking briefly.

Category

One-day depot penicillin with elevated blood levels

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 3.5 %
pH-value6.0 - 7.5
Sterility
(USP/Ph.Eur.)		sterile
Bacterial endotoxins
(LAL-test/USP)		not more than 0.01 EU/100 IU
Assay/Content
  • Penicillin G (HPLC):
    975 - 1075 IU/mg
  • Penicillin G Procaine (HPLC):
    730 - 810 IU/mg

Pharmacopoeial quality

The mixture corresponds to BP; the active substances correspond to USP, BP, Ph.Eur.

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