In pharmaceutical preparations

As predictable from the similarity of the properties of the two gums, quince seed gum is used in the appHcations described above for psyllium seed gum. Specific appHcations are in cosmetics and hair-setting lotions. It has also been used as an emulsifier and stabilizer in pharmaceutical preparations. 

Lactic acid is generally recognized as safe (GRAS) for multipurpose food use. Lactate salts such as calcium and sodium lactates and esters such as ethyl lactate used in pharmaceutical preparations are also considered safe and nontoxic (7). The U.S. Food and Dmg Administration fists lactic acid (all isomers) as GRAS and sets no limitations on its use in food other than current good manufacturing practice (46). 

Wintergreen Oil. Water distillation of the leaves of Gaultheriaprocumbens L. yields an oil which consists of essentially one chemical constituent, methyl saUcylate. Because of this, the oil has been almost totally replaced by the synthetic chemical. Natural oil of wintergreen [68917-75-9] is a pale yellow to pinkish colored mobile Hquid of intensely sweet-aromatic odor and flavor. The oil or its synthetic replacement find extensive use in pharmaceutical preparations, candy, toothpaste, industrial products, and in rootbeer flavor. In perfumery, it is used in fougnre or forest-type fragrances. 

Gelatinous boehmite, called alumina gel in commeicial use, is used in the piepaiation of adsorbents, desiccants (qv), catalysts, and catalyst supports (see Catalysts, SUPPORTBd). A significant amount is used in pharmaceutical preparations. 

Chloroform was used chiefly as an anesthetic and in pharmaceutical preparations immediately prior to World War II. However, these uses have been banned. Annual output in both the United States and the United Kingdom was between 900 and 1350 metric tons. During the war, chloroform production in the United States tripled, largely to meet the requirement for penicillin manufacture. Demand for chloroform continued to increase in the postwar period as its technical appHcations were extended. Consumption continues to increase at a comparatively rapid rate. Chloroform is now used primarily in the manufacture of HCFC-22, monochlorodifluoromethane, a refrigerant, and as a raw material for polytetrafluoroethylene plastics. 

SPECTROPHOTOMETRIC DETERMINATION OF ATORVASTATIN AND FLUVASTATIN IN PHARMACEUTICAL PREPARATIONS AFTER DERIVATIZATION WITH 9-CHLOROMETHYLANTHRACENE... 

The combined ether extracts were washed with 5% aqueous sodium bicarbonate solution, dried over anhydrous sodium sulfate, and fractionally distilled in vacuo. The fraction boiling at about 145° to 150°C at the pressure of 0.5 mm of mercury, weighing 61 g and consisting of 1-methyl-5-allyl-5-(1-methyl-2-pentynyl) barbituric acid, was collected. The only distillate was substantially pure, and could be used as such In pharmaceutical preparation or a salt could be prepared therefrom according to the procedures disclosed hereinafter. On standing, the oil crystallized. The crystalline 1-methyl-5-allyl-5-( 1-methyl-2-pentynyl) barbituric acid melted at about 60° to 64°C after recrystallization from dilute ethanol. 

In the pharmaceutical industry, GA is used in pharmaceutical preparations and as a carrier of drugs since it is considered a physiologically harmless substance. Additionally, recent studies have highlighted GA antioxidant properties (Trommer Neubert, 2005 Ali Al Moundhri, 2006 Hinson et al., 2004), its role in the metabolism of lipids (Tiss et al., 2001, Evans et al., 1992), its positive results when being used in treatments for several degenerative diseases such as kidney failure (Matsumoto et al., 2006 Bliss et al., 1996 Ali et al., 2008), cardiovascular (Glover et al., 2009) and gastrointestinal (Wapnir et al., 2008 Rehman et al, 2003). 

Ethanol (CH3CH2OH) is widely used as a disinfectant and antiseptic. The presence of water is essential for activity, hence 100% ethanol is ineffective. Concentrations between 60 and 95% are bactericidal but a 70% solution is usually employed for the disinfection of skin, clean instruments or surfaces. At higher concentrations, e.g. 90%, ethanol is also active against most viruses, including TUV. Ethanol is also a popular choice in pharmaceutical preparations and cosmetic products as a solvent and preservative. 

One of the uses of mains water is for washing chemicals used in pharmaceutical preparations to remove impurities or imwanted by-products of a reaction, and although the bacterial count of the water may be low, the volume used is large and the material being washed may be exposed to a considerable number of bacteria. 

Chapter 10 is devoted to the preparation and purification of hydrophilic vitamins (C, Bj, Bj, Bg, B[2, nicotinic acid and nicotinamide, pantothenic acid, biotin, and folic acid) in pharmaceutical preparations, food products, and biological samples. 

Amin, M., Simultaneous determination of prostaglandins (PG) E2, A2 and B2 and stability studies of PGE2 in pharmaceutical preparations by ion-pair reversed phase HPLC, Pharm. Acta. Helv., 64, 45, 1989. 

Phyllosilicates, in addition to talc and silica, have recently been evaluated for their use as tableting excipients. These compounds include the smectites, pa-lygorskites, and sepiolites [85a]. Although they show some promise, current levels of metallic impurities are currently too high for use in pharmaceutical preparations. 

It is recommended that daily saccharin intake be maintained below 1 g because of a risk of bladder cancer. A lifetime daily diet containing 5-7.5% saccharin has induced bladder tumors in rats [69]. However, it is probable that saccharin is only a very weak carcinogen in humans. The amount contained in pharmaceutical preparations is well below the recommended maximum human daily intake. 

Insensitive to impact, it decomposes, sometimes explosively, above its m.p. [1], particularly if heated rapidly [2], Although used in aqueous solutions as a preservative in pharmaceutical preparations, application of freeze-drying techniques to such solutions has led to problems arising from volatilisation of traces of hydrazoic acid from non-neutral solutions, condensation in metal lines, traps or filters, and formation of heavy metal azides in contact with lead, copper or zinc components in the drying plant [3,4],... 

Cavrini et al. [32] reported the development of a colorimetric method for the determination of miconazole nitrate in pharmaceutical preparation. The method is based on the formation of a yellow complex between the drug and bromocresol green. The absorption peak of this complex, extracted by chloroform over the pH 2—4 range, was at 424 nm, and linear response was obtained from 3—13 pg/mL. The molar absorptivity of the complex in chloroform was 1.845 x 104. This procedure is suitable for the analysis of miconazole nitrate in commercial dosage forms. 

Lemli and Knockaert [33] described a spectrophotometric method for the determination of miconazole nitrate suspensions and other organic bases in pharmaceutical preparations by the use of cobalt thiocyanate. The drug and the amines (as their anhydrous hydrochlorides in dichloromethane) react with solid cobalt thiocyanate to form an ion-pair complex that contains two molecules of base to one [Co(SCN)4]2. The complex is determined quantitatively by spectrophotometry versus dichloromethane at 625 nm with rectilinear response for up to 400 pg/mL of the base. This method was applied to miconazole nitrate suspensions and the coefficient of variations were generally <2%. 

For identification of oxytetracycline in pharmaceutical preparations, USP 28 [1] describes Method II under identification of tetracycline <193> (see Table 1), BP 2003 [4] describes a TLC and color test. 

Perez Ruiz et al. [26] determined penicillamine and tiopronin in pharmaceutical preparations by flow injection fluorimetry. The procedure is based on the oxidation of these drugs by thallium(III), whereupon the fluorescence of T1(T) produced in the oxidation of penicillamine is monitored using excitation at 227 nm and emission at 419 nm. A linear calibration graph for penicillamine was obtained between 3 x 10-7 and 8 x 10 5 6 M. 

Garcia et al. [45] determined penicillamine in pharmaceutical preparations by FIA. Powdered tablets were dissolved in water, and the solution was filtered. Portions (70 pL) of the filtrate were injected into a carrier stream of water that merged with a stream of 1 mM PdCl2 in 1 M HC1 for determination of penicillamine. The mixture was passed though a reaction coil (180 cm long) and the absorbance was measured at 400 nm. Flow rates were 1.2 and 2.2 mL/min for the determination of penicillamine, the calibration graphs were linear for 0.01-0.7 mM, and the relative standard deviation (n = 10) for 0.17 mM analyte was 0.8%. The method was sufficiently selective, and there were no significant differences between the labeled contents and the obtained results. 

Abou-Ouf et al. [16] described a spectrophotometric method for the determination of primaquine phosphate in pharmaceutical preparation. Two color reactions for the analysis of primaquine phosphate dosage form, which are based on 2,6-dichlor-oquinone chlorimide and l,2-naphthoquinone-4-sulfonate, were described. The reactions depend on the presence of active centers in the primaquine molecule. These are the hydrogen atoms at position 5 of the quinoline nucleus and the primary amino group of the side chain. The method was applied to tablets of primaquine phosphate and a combination of primaquine phosphate and amodiaquine hydrochloride. 

Abdel-Salam et al. [21] described a sensitive and simple spectrophotometric method for the determination of primaquine and other antimalarial drugs. The method is based on the formation of complexes between iodine (as an acceptor) and the basic drug in chloroform solution. Optimum conditions were established for the determination of primaquine, in pure form or in pharmaceutical preparation. Results were accurate and precise. 

Hassan et al. [39] used a sensitive color reaction method for the determination of primaquine in pharmaceutical preparation. Primaquine was treated with diazo-p-nitroaniline in acidic medium to give an orange-yellow product with an absorbance maximum at 478 nm. When the medium was made alkaline, bathochromic, and hypochromic shifts occurred the new maximum was located at 525 nm. The mean percentage recoveries for authentic samples amounted to 100 and 100.21 by the acid and alkaline procedures, respectively (P = 0.05). Both reactions could be used to determine primaquine salts in pharmaceutical preparations. The results obtained were in good agreement with those of the official methods. Recoveries were quantitative by both methods. 

Zhan and Mao [60] used a simple, fast, and selective alternating current oscilloscop-ic polarographic titration method for the determination of primaquine and other alkaloid phosphate in pharmaceutical preparation. The titration was carried out with a standard lead solution in hexamethylene tetramine buffer containing 1 M sodium chlorate (pH 5.5). The results obtained by this method are comparable to those obtained by pharmacopoeial method. 

Zhan [61] reported the use of an oscillopolarographic method for the determination of primaquine phosphate and other drugs in pure form and in pharmaceutical preparations. The sample solution was mixed with potassium bromide and 6 M hydrochloric acid and the mixture was titrated with 0.1 M sodium nitrite. A micro platinum electrode and a platinum electrode were used as indicators and reference electrodes, respectively. The mean recoveries were 96.88-99.88%. Results agreed well with those obtained by the Chinese Pharmacopoeia method. 

Lanolin is a wax secreted by the sebaceous glands of sheep it is obtained from wool and it has been used as a lubricant and as an ingredient in pharmaceutical preparations. It contains esters of long chain alkanoic acids, both linear and branched, and of hydroxya-cids, cholesterol and lanosterol [2,83]. 

V.G. Bonifacio, L.H. Marcolino, M.F.S. Teixeira, and O. Fatibello-Filho, Voltammetric determination of isoprenaline in pharmaceutical preparations using a copper(II) hexacyanoferrate(III) modified carbon paste electrode. Microchem. J. 78, 55-59 (2004). 

The luminol reaction has also been used for the CL determination of organic substances such as penicillins [32] and tartrate ion [30] in pharmaceutical preparations by their inhibitory effect on the luminol-iodine and luminol-periodate-manganese(II)-TEA system, respectively. As can be seen from Table 1, the results were quite satisfactory. In the indirect determination of penicillins by their inhibitory effect on the luminol-iodine system, the stopped-flow technique improves the accuracy and precision of the analytical information obtained, and also the sample throughput [32], Thus, in only 2-3 s one can obtain the whole CL signal-versus-time profile and calculate the three measured parameters formation and... 

When the influence was studied of different surfactants on the CL intensity of the reaction of lucigenin with isoprenaline, it was found that while cationic surfactants such as HTAH and HTAB and anionic surfactants such as SDS decrease the CL signal, the presence of Brij-35 increases the signal by a factor of 2.1 compared to that obtained in an aqueous medium [61]. As a result, a quite sensitive analytical method has been established for determination of isoprenaline, using Brij-35 as a CL enhancer. Application of the method has been satisfactorily verified with the determination of isoprenaline in pharmaceutical preparations. 

TLC has been used to identify and quantify aspirin in pharmaceutical preparations and body fluids. Data have been summarized in Table 5. Readout by densitometers108/109 and TLC separation as student experiments110 have also been described. 

Determination in Pharmaceutical Preparations The following tabulation of references high-lights those methods (see Section 5) useful in pharmaceutical analysis. 

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