Penicillin G Sodium

Benzylpenicillin Sodiumbuffered, sterile mixture

Molecular formula:
C16H17N2O4S.Na
Molecular weight:
356.4
CAS registry no.:
69-57-8
 Sodium

Application

Sterile mixture of Penicillin G Sodium and approx. 4.3 % of sodium citrate buffer. The mixture can be filled into vials without adding any excipients.

Antibiotic category

Short-acting penicillin for high initial blood levels

Packaging

Storage

Store below 25°C,
Protect from light and moisture

Shelf life

60 months

Specification

Appearancewhite to whitish, crystalline powder
Loss on dryingnot more than 1.5 %
Fibers & suspended matterpractically free from fibers and suspended matter
Particulate matternot more than particle level 5
Clarity of solution
(3.0 g in 10.0 ml water)		clear
pH-value6.0 - 7.5
2-Ethylhexanoic acid
(GC)		not more than 0.5 %
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
  • Penicillin G Sodium (HPLC):
    91.0 - 97.0 % 1)
  • Penicillin G (HPLC):
    1420 - 1667 USP-U/mg
    85.0 - 91.0 % 1)
1) Based on the dried substance

Pharmacopoeial quality

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