Penicillin V

Phenoxymethylpenicillinmicrofine, oral

Molecular formula:
C16H18N2O5S
Molecular weight:
350.4
CAS registry no.:
87-08-1

Application

Suitable for the manufacture of oral dosage forms, especially tablets, and film-coated tablets. Good bioavailability values are achieved due to the small particle size of the substance.

Antibiotic category

Oral penicillin with reliable absorption

Packaging

Storage

Store below 25°C,
Protect from light and moisture

Shelf life

60 months

Specification

Appearancewhite, crystalline powder
Specific optical rotation+186° to +200° 1)
Absorbances
  • 274 nm:
    not less than 0.56
  • 306 nm:
    not more than 0.36
Particle size
(mass distribution, image analysis)		x(50,3): 4 – 12 µm
80 %: 2 – 26 µm
exceeding 50 µm:
not more than 5 %
exceeding 125 µm:
not more than 1.0 %
Water content
(Karl Fischer)		not more than 0.5 %
Clarity of solutionclear
Colour valuenot more than 20
pH-value2.5 - 4.0
Phenoxyacetic acid
(HPTLC)		not more than 0.5 %
4-Hydroxyphenoxymethylpenicillin
(HPLC)		not more than 4.0 %
Largest impurity individually
(Ph.Eur./HPLC)		not more than 1.0 %
AssayPenicillin V (HPLC):
95.0 - 100.5 % 1)
1) Based on the anhydrous substance

Pharmacopoeial quality

USP, BP, Ph.Eur.