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Molecular Identity Testing

Meaning

Molecular identity testing is a rigorous, high-precision quality control procedure that employs advanced analytical chemistry techniques, such as High-Performance Liquid Chromatography (HPLC) or Mass Spectrometry, to unequivocally confirm the precise chemical structure and purity of an Active Pharmaceutical Ingredient (API). This mandatory testing ensures that the raw material is chemically identical to the claimed compound at the molecular level, thereby preventing the accidental or deliberate use of incorrect, substituted, or contaminated substances in compounded medications. It represents a fundamental and non-negotiable safeguard in pharmaceutical quality assurance and patient safety.