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Degradation-Related Impurities

Meaning

Degradation-related impurities are chemical byproducts that are unintentionally generated within a pharmaceutical product due to the breakdown of the active pharmaceutical ingredient (API) or the excipients over time or when exposed to various stress conditions such as heat, light, or humidity. These unwanted compounds are chemically distinct from process-related impurities and possess the potential to significantly compromise the potency, overall safety, and physical stability of the compounded hormonal preparation. Strict regulatory standards unequivocally mandate that these impurities must be precisely identified, accurately quantified, and maintained below established, clinically safe thresholds to ensure consistent drug quality and patient safety. Their measurable presence serves as a direct, quantifiable indicator of product instability and ultimately limits the shelf-life of the medication.