Quality control of Pharmaceuticals

Pharmaceutical microbiology may be defined as that part of microbiology which has a special bearing on pharmacy in all its aspects. This will range fiom the manufacture and quality control of pharmaceutical products to an understanding of the mode of action of antibiotics. The full extent of microbiology on the pharmaceutical area may be judged fiom the chapter contents. 

Korman, M., Vindevogel, J., and Sandra, P. (1994). Application of micellar electrokinetic chromatography to the quality-control of pharmaceutical formulations — the analysis of xanthine derivatives. Electrophoresis 15, 1304—1309. 

Extensive use has been made of NIRA in agriculture where it has been used to determine the protein, fibre, water and triglyceride contents of feedstuffs and the quality of crops. By training the computer to recognise the near-infrared (NIR) spectra of the major components making up a crop, the individual components can be monitored in the crop itself. The components that can be measured by NIRA often cannot be measured by the usual spectroscopic methods. The fundamental work done in the quality control of agricultural products can be readily extended to the quality control of pharmaceutical formulations. 

There are many GC detectors available although the flame ionisation detector remains the most widely used and the most widely applicable to quality control of pharmaceutical products. However, newer detectors such as the plasma emission detector for analysis of trace impurities or the GC-FTIR detector for the structural characterisation of components in mixtures are becoming increasingly important. 

The longest chapter deals with high-pressure liquid chromatography, which is the most widely used technique for the quality control of pharmaceuticals and which could fill several books until one realises that many analyses are based on a few... 

Corti, P., Dreassi, E., Murratzu, C., Corbini, G., Ballerini, L. and Gravina, S. (1989) Application of NIRS to the quality control of pharmaceuticals. Ketoprofen assay in different pharmaceutical formulae Pharmaceutica Acta Helvetiae 64, 140-145. 

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

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... 

TABLE 4 Analytical Methods for Characterization and Quality Control of Pharmaceutical Peptides and Proteins... 

Gilg, D., Riedl, B., Zier, A., and Zimmermann, M. F. (1996), Analytical methods for the characterization and quality control of pharmaceutical peptides and proteins, Pharm. Acta Helv., 71, 383-394. 

Sarri, A.K., Megoulas, N.C., and Koupparis M.A. Development of novel hquid chromatography evaporative hght scattering detection method for bacitracins and apphcations to quality control of pharmaceuticals. Arwl. Chim. Acta 2006, 573-574, 250-257. 

Japanese Ministry of Health and Welfare (1997), Regard to Retention of Records by Using Magnetic Media, Concerning Manufacturing Control and Quality Control of Pharmaceutical Products and Medical Devices, Open Letter to Every Prefectural Health Lead Officer, Inspection Guidance Division of Pharmaceutical and Medical Safety Bureau, September 18. 

Ar)me et al. [26] presented rapid liquid chromatographic procedures for quality control of pharmaceuticals and human serum containing antihistamines, meclizine, and buclizine alone or in combination with pyri-doxine using acetonitrile water (80 20) as a mobile phase (pH adjusted to 2.6), methylparaben as internal standard deviation and UV detection was made at 230 nm. The results obtained showed a good agreement with the declared content. The method had good linearity in the range of 0.03-10 pg/ml for pyridoxine and (0.025-10 pg/ml) for meclizine and buclizine serum concentration with a correlation coefficient of 0.9999. 

Peak purity is of utmost importance in the quality control of pharmaceutical products. The contents of... 

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. 

The Department of Pharmacy plays cin important role concerning pharmaceutical legislation on several matters such as pharmaceuticcil mcirket, distribution and quality control of pharmaceutical products, setting of reimbursement lists, and supervising the publishing of official documents on pharmaceutical products. A close cooperation with physicians and pharmacists organisation representatives exists for cdl of these matters. 

Health Minister Order No. 200. 1992. Improvement of the System for Expertise, Standardisation, Registration and Quality Control of Pharmaceuticeds, Diagnostics. 

NIR Imaging Spectroscopy for Quality Control of Pharmaceutical Drug Formulations 335... 

The simplicity and robustness of the method makes it well suited to a number of practical analytical applications, such as sensitive noninvasive in vivo disease diagnosis, security screening and the quality control of pharmaceutical tablets. The concept is also potentially applicable to fluorescence spectroscopy, NIR tomography of turbid media and other general applications, where the enhanced coupling of laser radiation into a turbid medium is beneficial an example is the case of photodynamic therapy in cancer treatment of subsurface tissues. 

A similar need exists in the quality control of pharmaceutical capsules and coated tablets, where their bulk content may be required. Although in many applications conventional Raman spectroscopy has proven to be very effective, in some cases the Raman signal or interfering fluorescence emanating from the capsule shell or tablet coating can severely reduce the sensitivity of conventional Raman spectroscopy. 

Key personnel responsible for supervising the manufacture and quality control of pharmaceutical products should possess the qualifications of a scientific education and practical experience required by national legislation. Their education should indude the study of an... 

Evaluation of the dissolution rates of drug substances from their dosage forms is extremely important in the development, formulation, and quality control of pharmaceutical agents [9,63-65]. Such evaluation is especially important in the characterization of polymorphic systems owing to the possibility of bioavailability differences that may arise from differences in dissolution rate that may themselves arise from differences in solubility [4]. The wide variety of methods for determining the dissolution rates of solids may be categorized either as batch methods or as continuous flow methods, for which detailed experimental protocols have been provided [66]. 

JaworskaM., Szulinska G, WiUc M., Tautt J., Capillary electrophoretic separation of IV-acetylcysteine and its impurities as a method for quality control of pharmaceuticals. J. Chromatogr. A, 853,479-485 (1999). 

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