Analytical Profiles of Drug Substances, Excipients, and - download pdf or read online

By Harry G. Brittain

ISBN-10: 0122608267

ISBN-13: 9780122608261

Even though the authentic compendia outline a drug substance as to id, purity, energy, and caliber, they often don't supply different actual or chemical information, 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 means of the affiliate Director of Analytical study and improvement for the yank organization of Pharmaceutical Scientists, Analytical Profiles of Drug elements and Excipients brings this knowledge jointly into one resource. The scope of the sequence has lately been multiplied to incorporate profiles of excipient fabrics.

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Example text

90 MHz 'H-NMR spectrum of benzoic acid in chloroform-d. I . 1 Hz) 2 H,, H, GUNAWAN INDRAYANTO ET AL. 22 coupling observed was the coupling between ortho protons (H2 and H,; H, and H,; J = 7-8 Hz). The coupling of meta protons was not observed. 2 I3C-NMR Spectrum The broad band decoupled I3C-NMR spectrum of benzoic acid is shown in Figure 8. 6 MHz. Chemical shifts were measured relative to tetramethylsilane, and assignments for the observed peaks are found in Table 5. 4. Mass Spectrometry The electron impact (Figure 9) and chemical ionization (figures 10 and 1 1) spectra of benzoic acid were obtained using a Finnigan Mat 8200 mass spectrometer.

4. Determination of Benzoic Acid in the Presence of Salicylic Acid The British P 1993 [ 151 describes a procedure to determine benzoic acid in benzoic acid ointment that also contains salicylic acid. In this method, 2 g of the ointment is added to 150 mL water, and warmed until melted. 1 M NaOH, using phenolphthalein solution as the indicator. Salicylic acid is assayed by a spectrophotometric procedure, and its content subtracted from the total acid value to obtain the benzoic acid content. 5 Spectrophotometric Methods of Analysis The AOAC 16'h edition describes a difference spectrophotometric method for the analysis of benzoic acid in various food preparations, such as jam, jellies, soft drinks, catsup, beverages, and fruit juices [ 141.

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


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