§ 436.214 - Heat stability.

Store an accurately weighed portion of the sample of approximately 30 milligrams in an unstoppered 50-milliliter Erlenmeyer flask for 4 days in an electric oven at 100° C±1° C. At the end of this period, remove the flask from the oven and allow to cool in a desiccator. Accurately weigh an unheated portion of the original sample of approximately 30 milligrams. Assay both the heated and unheated samples for potency as directed in § 436.204 or § 436.205 of this chapter. Determine the percent loss from the difference in potency between the unheated original sample and the heat-treated sample.