Analytical Profiles of Drug Substances and Excipients, Vol. by Harry G. Brittain

By Harry G. Brittain

Even though the authentic compendia outline a drug substance as to id, purity, energy, and caliber, they more often than not don't offer different actual or chemical info, nor do they checklist tools of synthesis or pathways of actual or organic degradation and metabolism. Such info is scattered during the clinical literature and the documents of pharmaceutical laboratories. Analytical Profiles of Drug components and Excipients, brings the newest info jointly in a single source.•Represents a crucial contribution to the perform of pharmaceutical research• provides an outstanding evaluate of actual, chemical, and biomedical homes of a few on a regular basis pharmaceuticals• each one quantity within the sequence incorporates a cumulative index

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0 mL of the Test Solution into a 100-mL volumetric flask, diluting to volume with Diluent, and mixing. Procedure: The assay is performed by injecting equal volumes (about 20 ~tL) of the Test Solution and the Diluted Test Solution into the HPLC system, recording the chromatograms, and measuring the peak responses. The method contains a directive that the elution of the Test solution is to be continued for twice the retention time of the aspartame peak. The sum of the responses of all the peaks in the chromatogram of the Test Solution, excluding the 5-benzyl-3,6-dioxo-2-piperazineacetic acid and aspartame peak responses, is not greater than the aspartame peak response obtained from the Diluted Test Solution.

T. Loftsson, and J. Baldvinsdottir, Acta Pharm. , 4, 329-330, (1992). 28. D. A. Connors, Pharm. , 10, 1174-1180 (1993). 29. D. A. Connors, J Pharm. , 83, 16901696 (1994). 30. H. Mazur, J. Tox. Environ. Health, 2, 243-249 (1976). 31. E. M. Molloy, M. Debono, P. Z. Farid, Pharm. , 6, 387-393 (1989). 32. N. Bhatt, K. T. Borchardt, Pharm. , 7, 593-599 (1990). 33. K. T. Borchardt, Pharm. , 7, 703-711 (1990). ASPARTAME 53 34. T. Tuncel and A. Araman, Acta Pharmaceutica Turcica, 31, 61-66 (1989). 35. T.

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