Summary of results for the ECP quality surveya.

aProduct Labels – number indicates a different brand, where a subsequent letter indicates a different batch. Bold text indicates non-compliance. With the exception of 2a, all samples yielded compliant results for identification (TLC and confirmation of levonorgestrel through the HPLC evaluation for dextronorgestrel). No sample showed evidence of dextronorgestrel.bDissolution presented with the stage required and average result.cRelated Substances – the level of any single related substance (S) should be less than 1.0% and the total amount of related substances (T) should be less than 2.0%.dAssay and Content Uniformity results presented as the average results and the minimum / maximum result found.eOnly Stage 1 was conducted because 3 tablets were found to be below 60%.fNo active release was observed on the 6 tablets tested. Additional tablets were tested for longer periods of release (1 hour) and observed ∼2–5% release of active.gA single peak was observed in the chromatogram (other than for levonorgestrel) which made a large contribution to the level of observed impurities.h30 tablets tested.