Determination and Characterization of Two Degradant Impurities in Bendamustine Hydrochloride Drug Product

Determination and characterization of two degradant impurities in bendamustine hydrochloride drug product.

Bendamustine hydrochloride is an alkylating antitumor agent with a good efficacy in the treatment of chronic lymphocytic leukemia (CLL) and B-cell non-Hodgkin's lymphoma (B-NHL). Under the stressed conditions, two degradant impurities in bendamustine hydrochloride drug product were detected by high-performance liquid chromatography. These two degradant impurities were isolated from preparative ...

Identification and Characterization of Potential Impurities in Raloxifene Hydrochloride

During the synthesis of the bulk drug Raloxifene hydrochloride, eight impurities were observed, four of which were found to be new. All of the impurities were detected using the gradient high performance liquid chromatographic (HPLC) method, whose area percentages ranged from 0.05 to 0.1%. LCMS was performed to identify the mass number of these impurities, and a systematic study was carried out...

Synthesis and characterization of impurities of barnidipine hydrochloride, an antihypertensive drug substance.

Barnidipine hydrochloride is a long term dihydropyridine calcium channel blocker used for the treatment of hypertension. During the process development of barnidipine hydrochloride, four barnidipine impurities were detected by high-performance liquid chromatography (HPLC) with an ordinary column (Agilent ZORBAX Eclipse XDB-C18, 150 mm×4.6 mm, 5 µm). All these impurities were identified, synthes...

RP-HPLC as an analytical method for the determination of bendamustine and its related impurities in bulk drug

comparison of the amount of debris extruded apically in two rotary techniques: flexmaster and m2

چکیده ندارد.