Analytical Methods for Drug Product

Very often the HPLC methods (assay and impurities) developed for the API are directly transferable to use with the drug product, depending upon the complexity of the product. The methods to consider for the drug product are:

• Identity
• Appearance
• Assay
• Degradation products
  
• Dissolution/Disintegration (for solid oral dosage forms)
  
• Uniformity of content (content uniformity using USP <905)>
• Residual solvents (if they are used in processing the dosage form)

The degradation products of drug products do not include the impurities from the API unless the degradation products of the product are the same as the impurities. In this case, the compounds need to be tracked.

Reporting of impurities/degradation products is a recurring topic of discussion between industry and the FDA. The FDA seems to always be pushing for lower and lower reporting limits. However, ICH Q3B clearly defines the reporting limits for deg products in drug product. This is dependent on the daily dosage and the reader is refered to the guidance for industry, http://www.fda.gov/cder/guidance/1317fnl.pdf

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