Penicillin G Potassium

Benzylpenicillin Potassiumsterile

Molecular Formula:
C16H17N2O4S.K
Molecular Weight:
372.5
CAS registry no.:
113-98-4
 Potassium

Application

Suitable for aseptic filling into vials using any customary filling machine. The product can be used for the manufacture of mixtures, as well as for 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

48 months

Specification

Appearancewhite to whitish, crystalline powder
Specific optical rotation:+270° to +300° 1)
Absorbances
(Ph.Eur.)		264 nm: 0.80 - 0.88
280 nm: not more than 0.10
325 nm: not more than 0.10
Loss on dryingnot more than 1.0 %
Water content
(Karl Fischer)		not more than 0.5 %
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-value5.5 - 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
  • Penicillin G Potassium (HPLC):
    96.0 - 102.0 % 1)
  • Penicillin G (HPLC):
    86.0 - 91.3 % 1)
    1440 - 1680 USP-U/mg
1) Based on the anhydrous substance

Pharmacopoeial quality

USP, BP, Ph.Eur.