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

By Harry G. Brittain

Even though the reputable compendia outline a drug substance through its id, purity, power, and caliber, they in most cases don't offer different actual or chemical facts, nor do they checklist equipment of synthesis or pathways of actual or organic degradation and metabolism. Such details is scattered during the medical literature and the records of pharmaceutical laboratories.Edited by means of the affiliate Director of Analytical examine and improvement for the yank organization of Pharmaceutical Scientists, Analytical Profiles of Drug elements and Excipients brings this data jointly in a single resource. The scope of the sequence has lately been multiplied to incorporate profiles of excipient fabrics.

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001%. 8 Limit of Oxalate The oxalate content of citric acid is determined using the following procedure [46]. To 10 mL of a 1 in 10 solution of the acid, which has been neutralized with 6 N ammonium hydroxide, add 5 drops of 3 N hydrochloric acid. The mixture is cooled, and then 2 niL of calcium chloride TS is added. No turbidity owing to precipitation of calcium oxalate is produced. 9 Organic Volatile Impurities When examined according to USP general procedure <467>, Method IV, the organic volatile content of a citric acid sample must meet the requirements [46].

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 . 4 kcal/mol), respectively [4]. 6 kal/mol) for citric acid anhydrous and monohydrate, respectively [6].

In addition to the citrate test, the Chinese pharmacopoeia [8] includes the test of igniting the crystal that should decompose gradually, but for which no caramel odor is perceptible (this is a distinction from tartaric acid). Identification test in to the British Pharmacopoeia [7] are arranged in two tiers, classified as the: first identification (tests B and E) and the second identification (tests A, C, D, and E). Test A: About 1 g of the acid sample is dissolved in 10 mL of water. The resulting solution is strongly acidic.

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