PhenoxymethylPenicilin Potassium; Pen V Potassium

Appearnce: white crystalline powder

Specific rotation: 223-230^o

Absorption

   274 nm         no less than 0.50

   306 nm         no less than 0.33

Water:   no more than 0.5%

Crystallinity: cystalline

Clarity of solution (water): clear

pH:  5.5-7.5

Phenoxyacetic acid: no more than 4.0%

4-Hydroxyphenoxymethylpenicilin potassium: no more than 4.0%

Related substance (individually): no more than 1.0%

Assay:

  Phenoxymethylpenicillin (HPLC): 1444 USP-U/mg - 1536 USP-U/mg

  Phenoxymethylpenicillin (HPLC, anhydrous substance): 95.0%-100.5%