Penicillin V Potassium

Phenoxymethylpenicillin Potassiumoral

Molecular Formula:
C16H17N2O5S.K
Molecular Weight:
388.5
CAS registry no.:
132-98-9
 Potassium

Application

Universal quality used for the manufacture of oral dosage forms. It is mainly used for the manufacture of granules for suspension with the help of conventional technologies, and for the production of tablets, as well as film-coated tablets.

Category

Oral penicillin with reliable absorption

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+223° to +230° 1)
Absorbances
  • 274 nm:
    not less than 0.50
  • 306 nm:
    not more than 0.33
Water content
(Karl Fischer)		not more than 0.5 %
Clarity of solution
(3 g in 10 ml water)		clear
pH-value5.5 - 7.5
Phenoxyacetic acid
(HPTLC)		not more than 0.5 %
4-Hydroxyphenoxymethylpenicillin potassium
(HPLC)		not more than 4.0 %
Largest impurity (Ph.Eur./HPLC)not more than 1.0 % 2)
Assay
  • Penicillin V (HPLC):
    1444 - 1536 USP-U/mg
  • Penicillin V Potassium (HPLC):
    95.0 - 100.5 % 1)
1) Based on the anhydrous substance
2) The value of the largest peak referring to specified or unspecified by-products and degradation products, calculated as phenoxymethylpenicillin potassium

Pharmacopoeial quality

USP, BP, Ph.Eur.