A validated HPLC method with UV detection for the assay and identification of Compound X was provided to Metrics Contract Services (MCS) for the release testing of Phase II clinical trial material. The method demonstrated consistent chromatography with the validating laboratory and met typical requirements for precision and linearity. A single main peak was present in the chromatogram and no impurities were observed. MCS scientists noted, during review of the chemical structure, that Compound X contained no major UV chromophores, and a very low wavelength (210 nm) was used for the analysis. Compound X is a drug substance-maleate salt. To ensure that the method with UV detection was appropriate for the identification, assay, and quantitation of impurities of Compound X, the drug substance was analyzed using an HPLC method with charged aerosol detection (CAD). Two peaks were observed in the CAD chromatogram, suggesting that the peak identified as Compound X in the original method was the maleate ion and not the active ingredient. Peak identification was further confirmed by HPLC-MS. HPLC-CAD methods for assay, identification, related substances and dissolution testing were developed and validated prior to release testing of Phase II clinical trial material, ensuring the safety and efficacy of the clinical trial material.
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