Development and validation of analytical method for determination of elemental impurities in micafungin for injection

• Main Authors: Sena Ozlem Gundogdu (Author), Seda Turhan (Author), Aynur Ozel Babacanoglu (Author), Tugce Catak (Author), Adem Sahin (Author)
• Format: Book
• Published: Polskie Towarzystwo Farmaceutyczne, 2024-06-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Elemental impurities contained in drug product create a risk for patients and potential toxic elemental impurities defined and classified in Guideline for Elemental Impurities Q3D(R1). Among the finished product dosage forms, parenteral products could be critical for elemental impurities because ele...