An impurity of Ampicillin sodium formed during a gradient reverse phase high performance liquid chromatography (HPLC) analysis of stress stability samples of the drug substance Ampicillin sodium, and the level of this impurity was found at up to 0.9%. This impurity was identified by LC-MS and characterized by (1H NMR, LC/MS/MS, elemental analysis). Based on the spectral data, the impurity was n...

We investigate velocity statistics of an impurity immersed in a uniform granular fluid. We consider the cooling phase, and obtain scaling solutions of the inelastic Maxwell model analytically. First, we analyze identical fluid-fluid and fluid-impurity collision rates. We show that light impurities have similar velocity statistics as the fluid background, although their temperature is generally ...

Impurity profiling is a highly intelligent, tedious and expensive task in standardizing the drug products for marketing Authorization. This task usually more complex when the proper impurity standards are not available and synthesis of the same require extra ordinary high cost and time. It has been observed that many a time application for ANDA/DMF/CEP is delayed due to extra ordinary delay in ...