Pangamic acid (vitamin B 15, pangametin, sopangamine): Its composition and determination in pharmaceutical dosage forms.

Pangamic acid is shown to be a mixture of variable composition. Criteria of identity and methods of analysis are described for five pharmaceutical dosage forms. Experimental results indicate that the products are not uniform in composition and that composition does not conform to label claims. No satisfactory preclinical drug application for any such preparation has so far been submitted to the Food and Drug Directorate.