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

By Harry G. Brittain

ISBN-10: 0122608283

ISBN-13: 9780122608285

Even though the reputable compendia outline a drug substance by means of its id, purity, power, and caliber, they commonly don't supply different actual or chemical info, nor do they record tools of synthesis or pathways of actual or organic degradation and metabolism. Such info is scattered in the course of the clinical literature and the records of pharmaceutical laboratories.Edited via the affiliate Director of Analytical study and improvement for the yank 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 elevated to incorporate profiles of excipient fabrics.

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Example text

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]. U of endotoxin per milligram, as regulated by the British Pharmacopoeia [7]. 11 Aluminum According to the British Pharmacopoeia [7], 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.

Three drops of phenolphthalein is added to this solution, and this is then titrated with 1 mol/L sodium hydroxide until a pink color is obtained. 50 H . POERWONO, K. HIGASHIYAMA, H. T. K. G. 3 Methods of the British and Indian Pharmacopoeias According to the British [7] and Indian [9] Pharmacopoeias, about 550 mg of analyte is accurately weighed and dissolved in 50 mL of water, or an accurately weighed of 2 g of analyte is dissolved in 100 mL of water. Each solution is titrated with 1 M sodium hydroxide using phenolphthalein solution as the indicator.

CITRIC ACID 35 Differential scann ng calorimetry thermogram of citric acid USP (anhydrate phase). -7- 36 H. POERWONO, K. HIGASHIYAMA, H. T. 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.

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