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

By Harry G. Brittain

Even though the reliable compendia outline a drug substance via its id, purity, energy, and caliber, they as a rule don't supply different actual or chemical information, nor do they checklist equipment of synthesis or pathways of actual or organic degradation and metabolism. Such details is scattered in the course of the clinical literature and the documents of pharmaceutical laboratories.Edited by means of the affiliate Director of Analytical examine and improvement for the yankee organization of Pharmaceutical Scientists, Analytical Profiles of Drug elements and Excipients brings this knowledge jointly in a single resource. The scope of the sequence has lately been extended to incorporate profiles of excipient fabrics.

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Unsaturated atmosphere. 54 H. POERWONO, K. HIGASHIYAMA, H. T. POERNOMO. K. SUDIANA, G. G. 3 High Performance Liquid Chromatography A food analysis handbook cited that citric acid can be determined by HPLC using reverse phase ion exchange and on proprietary columns for organic acids [56]. There is also an issue [61] that describes a liquid chromatographic assay for citric acid in over the counter carbamide peroxide products that uses indirect UV detection. The AOAC Official Method describes the determination of quinic, malic.

T. K. SUDIANA, G. G. BRITTAIN Figure 1. pH dependence of the distribution coefficient of citric acid. 0 -1 -2 -3 -4 n -al 0 -5 -6 -7 -a -9 I I I I I I 2 4 6 8 10 12 CITRIC ACID Figure 2. 23 Morphology of citric acid anhydrate, obtained using optical microscopy at a magnification of 40x. 24 H. POERWONO, K. HIGASHIYAMA, H. T. K. SUDIANA, G. G. BMTTAIN Figure 3. Morphology of citric acid monohydrate, obtained using scanning electron microscopy at (a) 35x and (b) 350x. CITRIC ACID Figure 4. Molecular structure of citric acid monohydrate.

Tiis yields a more distinct end-point, and its use is preferable to that of phcnolphthalein. 05 mg of the monohydrate. 1 Methods of the United States and Indonesian Pharmacopoeias Both the Indonesian Pharmacopcseia 1995 [ 101 and the Unites States Pharmacopoeia 24 [46] use the scimeprocedure. About 3 g of citric acid (accurately weighed) is dissolvec in 40 mL of water, phenolphthalein TS is added, and the resulting solution is titrated with 1 N sodium hydroxide to a pink end-point. 5 g of citric acid sample is accurately weighed and dissolved in 40 mL sf freshly boiled and cooled water.

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