Penicillin V Potassium

Phenoxymethylpenicillin PotassiumFor Direct Compression, oral

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

Application

Granules with an increased bulk density and excellent flowability and compressibility. The material is particularly suitable for direct compression after blending with tableting excipients like lubricants and dry binders.

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 granules
Specific optical rotation+223° to +230° 1)
Absorbances
  • 274 nm:
    not less than 0.50
  • 306 nm:
    not more than 0.33
Bulk density
(DIN EN ISO 60)		0.60 - 0.70 g/ml
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.