Penicillin G Sodium

Benzylpenicillin Sodiumsterile

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

Application

This quality, which is distinguished by its excellent flowability, is suitable for aseptic filling into vials using any customary filling machine. The product can be used for the manufacture of multiple or single active ingredient preparations.

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 almost white, crystalline powder
Specific optical rotation+285° to +310° 1)
Absorbances
(Ph.Eur.)
  • 264 nm: 0.80 - 0.88
  • 280 nm: not more than 0.10
  • 325 nm: not more than 0.10
Water content
(Karl Fischer)		not more than 0.3 %
Fibers & suspended matterpractically free from fibers and suspended matter
Particulate matternot more than particle level 5
Color value
(3.0 g in 10.0 ml water;
425 nm)		not more than 60
pH-value5.8 - 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
Largest impurity
(Ph.Eur./HPLC)		not more than 1.0 %
Assay
  • Penicillin G Sodium (HPLC):
    96.0 - 101.0 % 1)
  • Penicillin G (HPLC):
    90.0 -94.8 % 1)
1) Based on the anhydrous substance

Pharmacopoeial quality

USP, BP, Ph.Eur.