Control of pharmaceutical preparations

Specifications for the Quality Control of Pharmaceutical Preparations", 2nd Ed., World Health Organization,... 

Padl, T. and E. Liptak-Csekey. 1990b. Toxic Degradation Products of Active Ingredients A New Target for Quality Control of Pharmaceutical Preparations. Acta Pharmaceutica Jugoslavica 40 199-206. 

Microbiological quality control of pharmaceutical preparations and monitoring of production areas depend on the detection and quantification of micro-organisms. The classical, growth based, methods and some of the commercially available alternative methods are discussed. 

Food control, making use of electrochemical methods possesses many features In common with the drug control and the control of pharmaceutical preparations. One may conclude, however, that the problems are often even more complicated and more difficult. The reason is the more complex matrix (except for the drug analysis In biological samples described In some of the preceding paragraphs) and the presence of high concentration levels of surface-active compounds which usually adversely affect the course of the electrode processes. 

Related to the foregoing observations, the Board again recommends to all Governments that they should send pre-export notifications for shipments of pharmaceutical preparations containing ephedrines, control such preparations in the same way as they control the raw material and adopt adequate controls over the licit manufacture and distribution of precursors. The Board also draws the attention of competent authorities to the non-scheduled substances that traffickers search for when the monitoring of scheduled substances frequently used in illicit drug manufacture has been strengthened. 

The quality control of pharmaceuticals is particularly important. Care must be taken to limit the levels of toxic metals in the final product. The acid dissolution. procedures described above (e.g. 6 M hydrochloric acid) are often equally applicable for the determination of impurities. Complete destruction of the matrix by wet oxidation or dry ashing may be necessary to obtain a completely independent method. Raw materials, catalysts, preparative equipment and containers are all possible sources of contamination. Lead, arsenic, mercury, copper, iron, zinc and several other metals may be subject to prescribed limits. Greater sensitivity is often required for lead and arsenic determinations and this can be achieved by electrothermal atomisation. Kovar etal. [112] brought samples into solution using 65% nitric acid under pressure at 170—180° C and, after adding ammonium and lanthanum nitrate, determined arsenic in the range 10—200 ng in a graphite... 

Prior to the commercial availability of pharmaceutically prepared saline solutions, they were prepared by the lenswearer using salt tablets and distilled water. This method was undesirable and created many problems as the pH and osmolarity of such solutions were not controlled, which often resulted in parameter changes in some soft lenses. The major problem... 

Tbe Handbook of Pharmaceutical Excipients is a comprehensive, uniform guide to the uses, properties, and safety of pharmaceutical excipients, and is an essential reference source for those involved in the development, production, control, or regulation of pharmaceutical preparations. Since many pharmaceutical excipients are also used in other applications, the Handbook of Pharmaceutical Excipients will also be of value to persons with an interest in the formulation or production of confectionery, cosmetics, and food products. 

Chemicals and solutions. NFLX was obtained from the National Institute for the Control of Pharmaceutical and Biological Products. All the reagents were of analytical grade, and solutions were prepared with de-ionized, distilled water obtained from SZ-93 automatic double-distilled water (Shanghai, China). 

Chemicals. All chemicals used were of analytical grade doubly distilled water was used throughout. Rutin was obtained from the National Institute for the Control of Pharmaceutical and Biological Products of China. Other chemicals were the products of Xi an Chemical Plant. Rutin stock solution (500 mg/L) was prepared in methanol. Working solutions were freshly prepared by the dilution of the stock solution with water. NBS solution (0.01 mol/L) and H2O2 solution (0.1 mol/L) was prepared in water. CTMAB solution (0.2 %) was prepared in pH of 12.5 NaOH solution. 

Human serum albumin (HSA, essentially fatty acid-free) was obtained from Sino-American Biotechnology Company and used without further purification. Kaempferol (analytical grade) was obtained from the National Institute for Control of Pharmaceutical and Products, China. 0.5 mol/L NaCl solution was used to keep the ion strength at 0.1. Tris-HCl buffer was selected to keep the pH of the solution at 7.40. HSA solution of 1.5x1 O 5 mol/L was prepared in pH 7.40 Tris-HCl buffer solution. Kaempferol (l.OxlO"3 mol/L) solution was obtained by dissolving it in 50 mL ethanol. All other chemicals were of analytical reagent grade. Fluorescence spectra were recorded using a RF-5301 PC spectrofluorophotometer (Shimadzu) with a 150 W Xenon lamp and a 1 cm... 

The control of raw materials intended for the manufacture of pharmaceutical preparations is an important operation in the general organization of the preparation of medicines it... 

The second part of the chapter deals with the effects that are achieved when using surfactants to increase the standard of living of an individual - body care, enhancement of the action of pharmaceuticals, improvement of food quality (natural surfactants). Examples of the stability control of foams and emulsions using surfactant formulations as well as of the flow properties control of finished preparations are given. 

The control of pharmaceutics is the field where analytical isotachophorcsis has already proved to be advantageous, particularly due to its rapid and simplicity. Inorganic and organic components may be determined in one analysis only. This is illustrated by the analysis of a pharmaceutical preparation in which the sodium, calcium and ethyl morphine content must be controlled (Fig. 30) and by the analysis of an infusion solution in which the sodiiun, calcium and procaine contents are controlled (Fig. 31). 

It was proved that the derivative spectrophotometry can be recommended as a method for routine control analysis of pharmaceutical preparation of p-lactam antibiotics. Derivative spectrophotometry ensured the rapid analysis of parenteral dosage forms and also removed a "background" excipients in oral pharmaceutical dosage forms. 

Yu, W. Preparation and quality control of pharmaceutical composition for treating cardiovascular and cerebrovascular diseases. Faming Zhuanli Shenqing Gongkai Shuomingshu CN 1569156, 2005 Chem. Abstr. 2005,144, 57405. 

Final inspection is an essential element in controlling the quality of pharmaceutical preparations. In the first place, the final control comprises of the control of the batch documentation. In a larger organisation, such as a hospital, this is often the task of the production pharmacist. 

For quality control of the preparation process several references may be relevant. For production quality the EU-GMP is applicable for pharmaceutical industry. For product quality of pharmacy preparations, the monograph Pharmaceutical Preparations is applicable. It is a general monograph for the preparation or production of pharmaceutical preparations and it explicitly mentions pharmacy preparation, as preparation of unlicensed medicines. 

Ozkan, S A. Ozkan, Y. Aboul-Enein, H.Y. Quality control and drug dissolution studies of pharmaceutical preparations containing cerivastatin sodium by means of RP-HPLC, J.Liq.ChromcUogr.Rel.TechnoL, 2002, 25, 251-262. 

Sparidans, R.W. Den Hartigh, J. Vermeij, P. High-performance ion-exchange chromatography with in-line complexation of bisphosphonates and their quality control in pharmaceutical preparations, J.Pharm.Biomed.Anal., 1995,13, 1545-1550. 

The techniques described in this section may be applied to fermentation broths, concentrates obtained from recovery steps, control of pharmaceuticals, and antibiotic concentrates prepared for fortification of various animal feeds. 

In addition to its use as a central and respiratory stimulant, usually as caffeine, U.S.R, and caffeine and sodium henzoate injection, U.S.P., caffeine is extensively used as an ingredient in many types of pharmaceutical preparations, particularly internal analgesics, cold and allergy products, weight-control formulations (appetite depressants), and others. 

In the assay of pharmaceutical preparations containing calciferol in the absence of vitamin A interference may be due to decomposition products of calciferol or the vehicle used in the preparation. The subject has been investigated by Brealey and Stross. A spectrophotometric procedure has been shown to be free from interference from decomposition products of calciferol since they no longer show its selective absorption and their minor effect can be corrected for by application of a geometric three-point correction. However, the absorption peak of calciferol is rather flat and the correction is of limited value unless the composition of the preparations is known and blank readings are available, but the method is of particular value for control purposes. 

The last five years has seen a very rapid advance in the field of pharmaceutical analysis and the need for revision of the previous edition has become evident. Further, the claims for incorporation of all methods used in the examination of drugs—chemical, physical, microbiological and biological—cannot be denied any longer since each type of determination is sometimes necessary for the adequate control of medicinal preparations. 

Water Treatment. Water and steam chemistry must be rigorously controlled to prevent deposition of impurities and corrosion of the steam cycle. Deposition on boiler tubing walls reduces heat transfer and can lead to overheating, creep, and eventual failure. Additionally, corrosion can develop under the deposits and lead to failure. If steam is used for chemical processes or as a heat-transfer medium for food and pharmaceutical preparation there are limitations on the additives that may be used. Steam purity requirements set the allowable impurity concentrations for the rest of most cycles. Once contaminants enter the steam, there is no practical way to remove them. Thus all purification must be carried out in the boiler or preboiler part of the cycle. The principal exception is in the case of nuclear steam generators, which require very pure water. These tend to provide steam that is considerably lower in most impurities than the turbine requires. A variety of water treatments are summarized in Table 5. Although the subtieties of water treatment in steam systems are beyond the scope of this article, uses of various additives maybe summarized as follows ... 

Pharmaceutical Applications. Sucrose has a long history in the manufacture of pharmaceuticals. It imparts body to symps and medicinal hquids and masks unpleasant tastes. Sucrose also functions as a diluent to control dmg concentrations in medicines, as an ingredient binder for tablets, and to impart chewiness to the latter. Sustained-release medications and protective tablet glazes are prepared using sucrose (41). Sucrose-based sugar pastes are used to promote wound healing (58). 

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