What is it about?
Two polymorphs, I and II of fenretinide drug substance were produced as a mixture during scale-up. A methodology was needed to quantitatively measure the presence of each polymorph. It became evident that form II was least stable and its presence in mixtures had to be both minimized and quantitated.
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Why is it important?
The instability of form II in mixtures would accelerate the degradation of the compound, shorten its expiration.
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This page is a summary of: Analysis of N-(4-Hydroxyphenyl)retinamide Polymorphic Forms by X-ray Powder Diffraction, Journal of Pharmaceutical Sciences, October 1984, Elsevier,
DOI: 10.1002/jps.2600731032.
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