Pharmaceutical analysis definition

Presently there is no definitive text in HPLC that specifically addresses the needs of the busy pharmaceutical scientist on the pivotal subject of pharmaceutical analysis. This handbook strives to offer a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. The Handbook of Pharmaceutical Analysis by HPLC can be broadly classified into six major sections ... 

According to this definition, impurities also include all excipients used to form the dmg formulation, giving it adequate consistency, stability, solubility, taste, and other factors. This brings us to an apparent contradiction with the existing definition of chemical impurity in pharmaceutical analysis and analysis of dmgs, all excipients are treated the same as the active substance. This means that they have to meet the same standards in terms of their purity, cannot contain impurities in quantities larger than that of the active substance, and have to meet other standards referring to the chemical structure, properties, and so on. 

Validation is defined as the formal determination of the suitabUity of a given analytical method for an intended apphcation, achieving this by determining the rehabUity of results obtained [144], The following extract from the paper Vahdation of Analytical Results in Pharmaceutical Analysis by Renger et al. serves as the basis of this Chapter. Briefly, based on differences in requirements and even in definitions of terms used in the United States and Europe, experts from these coimtries and from Japan, who have been attending meetings of the International Conference for Harmonization (ICH 1-1CH 3) since 1993, have prepared a scheme of imiform requirements for the vahdation of analytical results [145]. The framework of the present book would be exceeded if all the details and commentaries were discussed here. The interested reader is therefore referred to the hterature [144]. 

This book has been designed to be particularly useful for both novice and experienced method development chemists in the pharmaceutical industry who are seeking to update their knowledge. It should continue to serve as a definitive reference source on pharmaceutical analysis for researchers, analysts, managers, and pharmaceutical industry regulators. 

A general definition of log P and log D, in its simplest form, can be given as the logarithm of the ratio (P or D) of the concentration of species of interest (the drug in a pharmaceutical context) in each phase, assuming the phases are immiscible and well separated prior to analysis. P is defined as the partition coefficient, whereas D is the distribution coefficient. However, the simplest form does not reveal some of the intricacies of the determination and use of these parameters, and further explanation is necessary. 

This wider definition can be summarized as the analysis of the process and had been developing in the pharmaceutical industry since around 2004-2006 to encourage better use of the information content of classical process analytical methods for the improvement of process development and connol. Particularly in the pharmaceutical industry, the acronym PAT for Process Analytical Technology was often being used to describe this newer definition of process analytics. 

Since factors other than innovation, such as commercial considerations affecting foreign entry onto the U.S. market, influence the observed patterns, analysis of the national origin of NCEs using the definitions employed here is not a highly sensitive or specific measure of pharmaceutical innovation. However, the observed trends are consistent with the tightening of regulatory policies first in the U.S. and then subsequently abroad. 

This definition can be described as analysis in the process and is closely related to the traditional role of analytical chemistry in process control. The classical scope of a process analytical method is to supplement the control scheme of a chemical, pharmaceutical or agricultural manufacturing process with data from a process analyzer that directly measures chemical or physical attributes of the sample. 

Panderi and Parissi-Poulou developed a microbore liquid chromatographic method for the simultaneous determination of benazepril hydrochloride and hydrochlorothiazide in pharmaceutical dosage forms [30]. The use of a BDS C-18 microbore analytical column was found to result in substantial reduction in solvent consumption and in increased sensitivity. The mobile phase consisted of a mixture of 25 mM sodium dihydrogen phosphate buffer (pH 4.8) and acetonitrile (11 9 v/v), pumped at a flow rate of 0.4 mL/min. Detection was effected at 250 nm using an ultraviolet absorbance detector. The intra- and inter-day relative standard deviation values were less than 1.25% (n = 5), while the relative percentage error was less than 0.9% (n = 5). The detection limits obtained according to the IUPAC definition were 0.88 and 0.58 pg/mL for benazepril hydrochloride and hydrochlorothiazide, respectively. The method was applied to the quality control of commercial tablets and content uniformity test, and proved to be suitable for rapid and reliable analysis. 

All of these sources, however, have their limitations. Franke s dissertation covers only Confederate pharmacy Smith focused only on the Union laboratories Evans book provides an interesting perspective and much useful data, but it offers little historical analysis and does not place pharmaceutical care in its larger social, political, and economic contexts and Hasegawa s article, despite being an extremely helpful start at a comprehensive study, serves principally as a blueprint for further work rather than as the final and definitive word on the subject. 

Of all the methods available for the physical characterization of solid materials, it is generally agreed that crystallography, microscopy, thermal analysis, solubility studies, vibrational spectroscopy, and nuclear magnetic resonance are the most useful for characterization of polymorphs and solvates. However, it cannot be overemphasized that the defining criterion for the existence of polymorphic types must always be a non-equivalence of crystal structures. For compounds of pharmaceutical interest, this ordinarily implies that a non-equivalent X-ray powder diffraction pattern is observed for each suspected polymorphic variation. All other methodologies must be considered as sources of supporting and ancillary information, but cannot be taken as definitive proof for the existence of polymorphism by themselves. 

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