Budesonid EP Verunreinigung H (CAS 313474-58-7) ist eine definierte prozess- und/oder abbauassoziierte Verunreinigung des Budesonid-Gerüsts mit der Summenformel C25H32O5 und einer Molekülmasse von 412,52 g/mol. Die strukturelle Nähe zum parenten Glucocorticoid spricht für eine Entstehung durch ortsselektive Oxidation, Acetalumlagerung oder als Rückstand aus synthetischen Zwischenstufen während Veresterungs- und Entschützungsschritten. Aufgrund der erforderlichen Trennung im Spurenbereich stützt sich die Charakterisierung typischerweise auf LC-MS/MS, hochauflösende LC-MS und orthogonale HPLC mit UV-Detektion; zur Strukturzuordnung kann NMR notwendig sein. Regulatorisch wird derartige Verunreinigung über pharmakopöische Spezifikationen und Impuritätsprofile überwacht.
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