For impurity profiles

Process validation should be extended to those steps determined to be critical to the quality and purity of the enantiopure drug. Establishing impurity profiles is an important aspect of process validation. One should consider chemical purity, enantiomeric excess by quantitative assays for impurity profiles, physical characteristics such as particle size, polymorphic forms, moisture and solvent content, and homogeneity. In principle, the SMB process validation should provide conclusive evidence that the levels of contaminants (chemical impurities, enantioenrichment of unwanted enantiomer) is reduced as processing proceeds during the purification process. 

Hammitzsch, M., Rao, R. N., and Scriba, G. K. E. (2006). Development and validation of a robust capillary electrophoresis method for impurity profiling of etomidate including the determination of chiral purity using a dual cyclodextrin system. Electrophoresis 27(21), 4334—4344. 

Recently, a CE method was introduced for impurity profiling of the human growth hormone somatropin produced by the recombinant DNA (rDNA) technology. ... 

CASE STUDY 2 EXAMPLE OF A FEASIBILITY STUDY FOR IMPURITY PROFILING... 

Very effective for impurity profiling due to its high resolving power. 

This second updated, revised and expanded edition of this book on LC-MS was written and finished in a period when interface innovations somewhat calmed down. Electrospray and APCl have become the interfaces of choice. At present, no major developments in interface technology can be foreseen that will lead to another breaktluough in LC-MS. In terms of applications and versatility, innovations continue to appear, e.g., in the use of LC-MS in characterization of combinatorial libraries and in other phases of dmg development, in the advent of electrospray time-of-flight instramentation for impurity profiling, in applications in the field of biochemistiy and biotechnology. 

As noted in Section 4.2.4.2, NMR may be particularly useful for impurity profiling because of the simplicity of the fluorine spectrum. Mistry etal. showed that fluorine-containing impurities in bulk dmg could be detected and quantitated down to approximately 0.1 mole% (by comparison with HPLC-UV traces) [205]. 

R479 O. D. Sherikar, P. J. Mehta and D. M. Khatri, Various Approaches for Impurity Profiling of Pharmaceuticals An Overview , J. Pharm. Res., [online computer file], 2011, 4, 1937, AvaU. URL http //jpronline.info/ article/view/8036/4121. 

With the increasing number, diversity, and complexity of compounds being analyzed, UPLC presents the possibility to extend and expand the utility of separation science. Today, UPLC is widely used for metabolite identification analysis of natural products and herbal medicines pharmacokinetic, toxicity, degradation, bioanalysis, and bioequivalence studies quality control and in drug discovery determination of pesticides and separation of various pharmaceutical-related small organic molecules, proteins, and peptides. UPLC is also used for impurity profiling, method development, and validation performed in quality assurance and quality control laboratories [46,47,56-69]. 

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