Comparative HPLC-UV and LC-MS/MS studies of impurity profiles of a reference sample (Xenical®, F. Hoffmann-La Roche Ltd., Switzerland) vs. generic (Lipiblock®, EMS-Sigma Pharma, a generic drug) were carried out with ethanol extracts of commercial samples. The generic formulation contained higher levels of common impurities as well as a considerable number of impurities not found in the reference product. The detected impurity profile of Lipiblock® revealed that it most likely is based on fermentation. Since the effect of the impurities is unknown, at this point fully synthetic Xenical® appears to offer a better safety margin than Lipiblock® which, however, compares quite well to other generic formulations.Colegio de Farmacéuticos de la Prov...
Impurity profiling is the process of acquiring and evaluating data that establishes biological safet...
LC-MS has become an important tool in all areas of drug discovery and development within pharmaceuti...
Objective: To investigate the pharmaceutical equivalence of ten brands of ibuprofen tablets (400 mg)...
Comparative HPLC-UV and LC-MS/MS studies of impurity profiles of a reference sample (Xenical®, F. Ho...
Comparative HPLC-UV and LC-MS/MS studies of impurity profiles of a reference sample (Xenical®, F. Ho...
Comparative HPLC-UV and LC-MS/MS studies of impurity profiles of a reference sample (Xenical (R), F....
In view of an increasing number of generic drugs emerging, a comparative study was performed includi...
As the drug safety and efficacy is hampered in the presence of an impurity, the international regula...
Purpose: Three different generic vancomycin products were compared using liquid chromatography–mass ...
Impurity is not a much-liked word by pharmaceutical and industry people, because they are concerned ...
Abdel Naser Zaid,1 Nihal Zohud,1 Bushra E’layan,1 Tasneem Aburadi,1 Nidal Jaradat,1 Iyad Ali,2...
Pegfilgrastim is administered as an adjunct to chemotherapy to reduce the incidence of febrile neutr...
Now a day’s qualification of impurities has become a major task for pharmaceutical industry in order...
Impurities are always an ‘essential evil’, that will however be present with the drug products with ...
The performance of five curve resolution methods was compared systematically for the identification ...
Impurity profiling is the process of acquiring and evaluating data that establishes biological safet...
LC-MS has become an important tool in all areas of drug discovery and development within pharmaceuti...
Objective: To investigate the pharmaceutical equivalence of ten brands of ibuprofen tablets (400 mg)...
Comparative HPLC-UV and LC-MS/MS studies of impurity profiles of a reference sample (Xenical®, F. Ho...
Comparative HPLC-UV and LC-MS/MS studies of impurity profiles of a reference sample (Xenical®, F. Ho...
Comparative HPLC-UV and LC-MS/MS studies of impurity profiles of a reference sample (Xenical (R), F....
In view of an increasing number of generic drugs emerging, a comparative study was performed includi...
As the drug safety and efficacy is hampered in the presence of an impurity, the international regula...
Purpose: Three different generic vancomycin products were compared using liquid chromatography–mass ...
Impurity is not a much-liked word by pharmaceutical and industry people, because they are concerned ...
Abdel Naser Zaid,1 Nihal Zohud,1 Bushra E’layan,1 Tasneem Aburadi,1 Nidal Jaradat,1 Iyad Ali,2...
Pegfilgrastim is administered as an adjunct to chemotherapy to reduce the incidence of febrile neutr...
Now a day’s qualification of impurities has become a major task for pharmaceutical industry in order...
Impurities are always an ‘essential evil’, that will however be present with the drug products with ...
The performance of five curve resolution methods was compared systematically for the identification ...
Impurity profiling is the process of acquiring and evaluating data that establishes biological safet...
LC-MS has become an important tool in all areas of drug discovery and development within pharmaceuti...
Objective: To investigate the pharmaceutical equivalence of ten brands of ibuprofen tablets (400 mg)...