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Latest Headlines
Xcelience and IriSys business alliance agreement strengthens regional access to CMC/Regulatory expertise
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Case Studies
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Case Study 6
Analytical Method Development for a Low Dose, Poorly Extractable Drug in a Semi-Solid
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Formulation of an NME below 10ug/gram for a topical application was requested by the sponsor. The resultant semi-solid dosage form was found to be suitable but difficulty in extracting the NME from the drug product was experienced.
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A series of experiments identified one of the components in the drug product was deteriorating the HPLC column and needed to be removed prior to analysis.
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An extraction method was developed and included a step to precipitate out the interfering excipient. The supernatant was collected, rinsed, and evaporated before being brought to a total volume of 5 mL. This low total volume was necessary for analysis of related compounds at a very low level.
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The recovery of the NME from the drug product is 100% and the method has been validated for use in routine testing of clinical supplies.
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