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.

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 & particulate matterpractically free from fibers and particulate matter
Particulate contamination
( Hiac Royco)
  • >= 10 µm: not more than 1000 per g
  • >= 25 µm: not more than 100 per g
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 % 2)
Assay
  • Penicillin G Sodium (HPLC):
    96.0 - 102.0 % 1)
  • Penicillin G (HPLC):
    90.0 -94.8 % 1)
  • Pencillin G Sodium (HPLC):
    1600 - 1690 IU/mg
1) Based on the anhydrous substance
2) The value obtained for the largest peak referring to a specified or unspecified by-product or degradation product, calculated as benzylpenicillin sodium, is stated as the result.

Pharmacopoeial quality

USP, BP, Ph.Eur.