By Harry G. Brittain
Even if the respectable compendia outline a drug substance as to id, purity, energy, and caliber, they ordinarily don't offer different actual or chemical facts, nor do they checklist tools of synthesis or pathways of actual or organic degradation and metabolism. Such info is scattered through the medical literature and the documents of pharmaceutical laboratories. Edited through the affiliate Director of Analytical study and improvement for the yankee organization of Pharmaceutical Scientists, Analytical Profiles of Drug components and Excipients brings this data jointly into one resource. The scope of the sequence has lately been accelerated to incorporate profiles of excipient fabrics.
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Additional resources for Analytical Profiles of Drug Substances, Excipients, and Related Methodology
8, 157 (1955). BRINZOLAMIDE Rex Hall', Grey Wavner', John Baker', Glenn Stafford2, Wayne Schneider2, Way-Yu Lin2, Jesse May3, Michael Curtis4,Craig Struble4, Bette McCue4, Dan Jasheway4, and David McGee' (1) Analytical Chemistry (2) Research SuppodPharmaceutics (3) Research/Discovery Synthesis (4)PharmacokineticslDrug Metabolism ( 5 ) Toxicology Research and Development Alcon Laboratories, Inc. 00 47 Copyright 0 1999 by Academic Prrsc All nphlr ufrepruduutlon In any form recrrved 48 REX HALLETAL.
The formation of an etherinsoluble white precipitate in about 10 minutes is a second positive identification. 2 Congealing range When tested according to USP general test <65 1>, melted benzoic acid should solidify in the range of 121 - 123°C. 3 Water Content The water content of benzoic acid is tested according to USP general test <921>, Method I, using a 1 in 2 solution of methanol in pyridine as the solvent. 7% water can be present. 4 Readily Carbonizable Substances When tested according to USP general test <27 1>, the resulting solution can have no more color than Matching Fluid Q.
Were used. ) at 5"C/min. for the separation of 20 substances (including benzoic acid) in cologne . A HP-5871 mass selective detector was used. Supelco Inc. 32 mm; 1 pm film) for the analysis of 25 semi-volatile acids, including benzoic acid [3 I]). , helium carrier gas at 35 mWmin, and a MS detector. 34 G U N A W A N INDRAYANTO ETAL. 3 GUNAWAN INDRAYANTO ETAL. 6 mm column and a variable wave length UV/VIS detector was recommended . 01 M KH,PO, (pH = 2) and methanol, and ending in 25 minutes with 60 %buffer 140 % methanol.
Analytical Profiles of Drug Substances, Excipients, and Related Methodology by Harry G. Brittain