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Isolation, Identification and Characterization of Unknown Impurity in Fermentation Based Active Pharmaceutical Ingredient Lovastatin.

Chandrakant Belwal, Divyesh Patel, Kamlesh Chauhan, Yogendrasinh Parmar, Ajay Singh Rawat, and Anand Vardhan

An unknown impurity in fermentation based drug substance lovastatin at 1.06 RRT was observed invariably in all batches when analyzed by HPLC as per Ph Eur. monograph. This impurity was isolated from the impurity enriched sample using reversed phase preparative HPLC and characterized by using spectroscopic (PMR, CMR, MASS and UV) and thermal analysis (DSC) techniques.