By Harry G. Brittain
Even supposing the reputable compendia outline a drug substance through its identification, purity, energy, and caliber, they quite often don't offer different actual or chemical info, nor do they record equipment of synthesis or pathways of actual or organic degradation and metabolism. Such info is scattered through the medical literature and the records of pharmaceutical laboratories.Edited by way of the affiliate Director of Analytical examine and improvement for the yankee organization of Pharmaceutical Scientists, Analytical Profiles of Drug ingredients and Excipients brings this data jointly in a single resource. The scope of the sequence has lately been extended to incorporate profiles of excipient fabrics.
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Additional info for Analytical Profiles of Drug Substances and Excipients, Vol. 28
15"C. The monohydrate crystals, which are colorless and translucent, belong to the orthorhombic system [ 1,2,4,6,29]. The morphology of citric acid monohydrate crystal was obtained using the Crystal Observation Technique and Scanning Electron Microscopy (JSM - TlOO), and is shown in Figure 3 . 1 Single Crystal Structure The single crystal structure of citric acid monohydrate was established by X-ray analysis. All measurements were made on a Rigaku AFC7R diffractometer with filtered Cu-K radiation and a rotating anode generator.
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. 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.
K. SUDIANA, G. G. BRITTAIN Figure 7. 001 N HCl. Figure 8. UTRIC ACID Infrared absorpticn spectrum of citric acid. 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.
Analytical Profiles of Drug Substances and Excipients, Vol. 28 by Harry G. Brittain