Several samples of Corn Starch supplied by four commercial companies were investigated for compliance with the United States Pharmacopeia XVIII specifications for granule size. Non were found to possess granules which exceeded the upper limit of 35 microns specified by the monograph.
Two methods of analysis for measuring the granule sizes are described: 1) a ”︁Variables Sampling Plan for Normally Distributed Lots with Single Specification Limit and with Specified Acceptable Quality Level (AQL), Lot Tolerance Percent Defective Level (LTPD), a and β″; and 2) a ”︁Single‐Sample Fraction‐Defective Plan (AQL, LTPD, α and β Specified)„.
It is suggested that manufacturers consider the use of a Single‐Sample Fraction‐Defective Plan (AQL, LTPD, α and β Specified) in particular for certifying lots which are to be labelled U.S.P. Starch.