Pharmaceutical industry characteristics forms

Comprehensive physicochemical characterization of any raw material is a crucial and multi-phased requirement for the selection and validation of that matter as a constituent of a product or part of the product development process (Morris et al., 1998). Such demand is especially important in the pharmaceutical industry because of the presence of several compounds assembled in a formulation, such as active substances and excipients, which highlights the importance of compatibility among them. Besides, variations in raw materials due to different sources, periods of extraction and various environmental factors may lead to failures in production and/or in the dosage form performance (Morris et al., 1998). Additionally, economic issues are also related to the need for investigating the physicochemical characteristics of raw materials since those features may determine the most adequate and low-cost material for specific procedures and dosage forms. 

Uses Creosote is a flammable, oily liquid with a characteristic smoky smell, caustic burning taste, but colorless in pure form. It is primarily used as a wood preservative and as a waterproofing agent, animal dip, an ingredient in fuel oil, and in the manufacture of chemicals and lampblack. It is extensively used in the pharmaceutical industry as an antiseptic, disinfectant, antipyretic, astringent, styptic, germicide, and expectorant. 

It has been highlighted earlier in the chapter that rubber, due to its chemical structure, has excellent resilience properties. This characteristic forms the basis for its widespread use for piston and closures. A review article by Morton (1987) highlighted that there is debate within the pharmaceutical industry as to where the true seal is formed in a parenteral vial package. The true seal is defined as the primary seal and Morton confirmed the location of both primary and secondary seals as shown in Figure 12.7. 

Aldolases are a group of C—C bond forming enzymes with widespread applications. The stereoselective aldol addition reaction catalyzed by aldolases represents an attractive alternative to conventional chiral organic chemistry methods for chemical and pharmaceutical industries. Aldolases are classified according to both their proposed catalytic mechanism and the structure of the donor substrate, their sources and microbial production processes being presented in this chapter. To design appropriate bioreactors for aldol synthesis, the characteristics of aldolase biocatalysts obtained after purification procedures in free and immobilized form are discussed. 

As many biologically important analytes do not exhibit efficient detection properties (UV or visible light absorption, fluorescence, or electrochemical activity), their detection limits are relatively low. For example, drugs with chiral centers exist naturally in racemic mixtures that are optically inactive due to the nearly equal proportion of the enantiomers. The determination of enantiomeric purity is of paramount importance in the pharmaceutical industry as each enantiomer may have different therapeutic characteristics. Currently, a method that offers multiple advantages for chiral separations is by converting enantiomers to diastereomers by precolumn derivatization with a pure fluorescent enantiomer. For instance, propranolol existing in racemic form may be analyzed by precolumn derivatization with (+ )-l-(9-fluorenyl)ethyl chloroformate. Well correlated calibration plots were found up to 400pmol and a reproducibility of <2% for each derivative. 

---