The chemical reaction rate for solid-state product formation in a pharmaceutical case study was monitored by equilibration with either a 75%, 21.5%, 75% relative humidity (RH) cycle ("high-low-high", HLH) or a 21.5%, 75%, 21.5% RH cycle ("low-high-low", LHL). For the HLH cycle, it was found that the degradant formation rate was reversible; that is, the rate at the final 75% RH step was equivale...

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 ...

Active pharmaceutical ingredients (APIs) can be assured to safe and effective with the help of stability-indicating procedures. An accurate comparison comprising utilization capillary zone electrophoresis (CZE) ultra-performance liquid chromatography (UPLC) for sensitive measurement ciprofloxacin (CPF) in presence its major photo-degradation product was conducted. The CZE UPLC working condition...

A detailed investigation of Valsartan`s light-induced degradation is reported. Based on UPLC-HRMS studies stressed solutions several pathways are proposed. Some the proposed structures were obtained by forced experiments. Examination analytical data including crystal allowed for structural revision one literature-known degradant. In addition, irradiation under aerobic conditions revealed furthe...

Abstract Background Tuberculosis is an infection that has high mortality rate in human as well animals if it remains unattained for long time. Scientists are always desirous to discover new molecules against Mycobacterium tuberculosis ; one of them bedaquiline which was recently approved treat multidrug resistance TB. During the clinical study molecule stability and impurity key aspects develop...

Abstract Zn-doped NaA molecular sieves were prepared by hydrothermal method using zinc nitrate, sodium metaaluminate, silica sol, etc. as raw materials. The samples characterized XRD, SEM, FT-IR, etc., 300W xenon lamp the light source. Rhodamine B (RhB) was used target degradant for photocatalytic experiments its activity. results showed that ion doping increased number of active sites on sieve...