By Harry G. Brittain
Even if the respectable compendia outline a drug substance by means of its id, purity, power, and caliber, they often don't supply different actual or chemical facts, nor do they record equipment of synthesis or pathways of actual or organic degradation and metabolism. Such details is scattered through the clinical literature and the records of pharmaceutical laboratories.Edited through the affiliate Director of Analytical examine and improvement for the yankee organization of Pharmaceutical Scientists, Analytical Profiles of Drug ingredients and Excipients brings this knowledge jointly in a single resource. The scope of the sequence has lately been multiplied to incorporate profiles of excipient fabrics.
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Additional resources for Analytical Profiles of Drug Substances and Excipients, Vol. 28
1 c 3 5 % 31 H. POERWONO. K. HIGASHIYAMA, H. T. K. SUDIANA, G. G. 2 H. POERWONO, K. HIGASHIYAMA, H. T. K. SUDIANA, G. G. BRlTTAIN Differential Scanning Calorimetry Differential scanning calorimetry was obtained on citric acid USP (anhydrate phase) using a TA Instruments model 9020. The thermogram is shown in Figure 6, and consists of a single endotherm identified as the melting phase transition. 2"C. The enthalpy of fusion computed for this sample was calculated as 229 J/g. 5 kcal/mol) and -1972 kJ/mol ( 4 7 1 .
Citric acid monohydrate loses its water of crystallization in dry air, in a vacuum over sulfuric acid, or when heated at about 40 to 50°C. On gentle heating, the monohydrate crystals soften at about 75°C with the loss of water, and finally melt completely in the range of 135 - 150°C. On rapid heating, the crystals melt at 100°C. solidify as they become anhydrous. 44-451. Figure 5. CITRIC ACID X-ray powder diffractionpattern of citric acid USP (anhydrate phase). 1 c 3 5 % 31 H. POERWONO. K. HIGASHIYAMA, H.
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. 04 mg of citric acid. 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  use the scimeprocedure.