By Harry G. Brittain
Even if the legitimate compendia outline a drug substance via its id, purity, energy, and caliber, they typically don't supply different actual or chemical info, nor do they checklist tools of synthesis or pathways of actual or organic degradation and metabolism. Such details is scattered through the medical literature and the records of pharmaceutical laboratories.Edited by means of the affiliate Director of Analytical learn 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 accelerated to incorporate profiles of excipient fabrics.
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Additional info for Analytical Profiles of Drug Substances and Excipients, Vol. 28
The powder pattern is shown in Figure 5, while a summary of the observed scattering angles, dspacings, and relative intensities is found in Table 1 1. X-ray diffractometer has been used to determine the composition in bulkprepared solidified citric acid melt, using a powdered sample as the reference standard. The powder pattern of anhydrous citric acid and bulkprepared solidified citric acid melt indicated that the bulk-prepared citric acid melt consisted of an amorphous and crystalline citric acid mixture ~401.
11 Aluminum According to the British Pharmacopoeia , if the citric acid under consideration is intended for use in the manufacture of dialysis solutions, the acid sample should comply with the test for aluminum. 0) is added. 2 ppm). 0, and 98 mL CITRIC ACID 49 of water is used as the reference solution. 0 is used tc prepare the blank. 12 Assay Citric acid is assayed by titratiori with 1 N sodium hydroxide VS to a pink phenolphthalein endpoint. The procedure calls for the dissolution of about 3 g of accurately weighed sample in 40 mL of water.
In the second, the sample is injected into the carrier system through a sampling valve (Flow Injection Analysis, FIA) . The method of elemental analysis uses ion selective electrodes (ISE) for the determination of elements in organic substances. The usual CITRIC ACID 51 decomposition procedures are used, and measurement with the ISE is used as the final step to simplify the determination of the decomposition products. In the determination of carbon, the citric acid is mineralized in a stream of oxygen and volatile decomposition products are passed over a suitable catalyst on which the ca-bon is converted quantitatively into carbon dioxide.
Analytical Profiles of Drug Substances and Excipients, Vol. 28 by Harry G. Brittain