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

By Harry G. Brittain

Even supposing the authentic compendia outline a drug substance by way of its identification, purity, power, and caliber, they ordinarily don't supply different actual or chemical facts, nor do they checklist tools 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 by way of the affiliate Director of Analytical learn and improvement for the yank organization of Pharmaceutical Scientists, Analytical Profiles of Drug components 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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37 38 H. POERWONO, K. HIGASHIYAMA, H. T. K. SUDIANA, G . G. 1 1 H-NMR Spectrum The 270 MHz 'H-NMR spectrum of citric acid was obtained in deuterated methanol using a JEOL JNM LA-270 spectrometer, and is shown in Figure 9. All chemical shifts arc: reported as 6 values (ppm) relative to tetramethylsilane (TMS) and re: idual CD30D as internal standards. The assignments for the observed bands are found in Table 13, together with multiplicities and coupling constants. 2 13 C-NMR Spectrum The broadband decoupled I3C-NMR spectrum of citric acid is shown in Figure 10.

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].

83 C(2), (34) Figure 1 1. CITRIC ACID Chemical ionization mass spectrum of citric acid. 43 44 Electron impact mass spectrum of citric acid. H. POERWONO, K. HIGASHIYAMA, H. T. K. SUDIANA, G. G. BRITTAIN Figure 12. 5) [M + 1 (H) - 90 (2 x C02H)I' CI (Isobutane) 46 H. POERWONO. K. HIGASHIYAMA, H. KUBO. T. K. SUDIANA, G. G. 1 Identification According to the United States Pharmacopoeia 24 [46], citric acid is identified by using a solution of the analyte responds to the test for Citrate (pyridine - acetic anhydride test) <191>.

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