Analytical strategies for pharmaceutical products:

Chromatography and MS are extensively used in the formulation development stage of generic drug products. The ICH Q3B guidelines address the reporting threshold, identification threshold, and qualification threshold for impurities in the drug product. Chromatography (LC) and Gas Chromatography (GC) are extensively used to analyze stable compounds. However, for labile compounds require derivatization prior to LC or GC analysis. For certain selected analyses, Liquid Chromatography- Ultraviolet Detection (LC-UVD) and Gas Chromatography-Flame Ionization Detection (GC-FID) techniques may be deemed suitable. However, Liquid Chromatography-Mass Spectrometry (LC-MS) and Gas Chromatography-Mass Spectrometry (GC-MS) are usually the techniques of choice when higher specificity and sensitivity are required. Gas Chromatography-Electron Capture Detection (GC-ECD) techniques are commonly used for halogenated PGIs/GIs to enhance sensitivity and selectivity. Occasionally, some spectroscopic techniques like Nuclear Magnetic Resonance (NMR), light scattering, and Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) are used in analyzing PGIs/GIs.

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