Method for pharmaceutical

G. Lunn, HPLC Methods for Pharmaceutical Analysis, Vol. 4, Wiley-Interscience Publication, John Wiley Sons, Inc., New York, 2000, pp. 1250-1256. 

Gad, S.C. (1989b). A tier testing strategy incorporating in vitro testing methods for pharmaceutical safety assessment. Flumane Innovations and Alternatives in Animal Experimentation 3 75-79. 

Bergman, S.W. and Gittins, J.C. (1985). Screening procedures for discovering active compounds. In Statistical Methods for Pharmaceutical Research Planning. (Peace, K. Ed.). Marcel Dekker, New York. 

Gad, S.C. (1989). A Tier Testing Strategy Incorporating In Vitro Testing Methods for Pharmaceutical Safety Assessment. Humane Innovations Alternatives Anim. Exp. 3 75-79. 

The residual titration method for pharmaceutical substances using potassium permanganate solution are mainly of two categories, namely ... 

Can one make use of NMR-Spectroscopy as an identification testing method for pharmaceutical substances Explain with typical examples. 

In summary, enzyme immobilization is extremely important in the scale-up of many biocatalytic processes. The preferred method for pharmaceutical production involves covalent binding through cross-linking or attachment to a support. Noncovalent attachment is less attractive, but it is heavily utihzed owing to the commercial availabihty of industrial quantities of some enzymes immobilized using this technique. 

Zhou, L., Thompson, R., Song, S., Elhson, D., Wyvratf J.M. A strategic approach to the development of capillary electrophoresis methods for pharmaceutical basic compounds nsing sulfated cyclodextrins. J. Pharm. Biomed. An. 2002, 27, 541-553. 

Capillary Electrophoresis Methods for Pharmaceutical Analysis, Volume 9 S. Ahuja and M.I. Jimidar, editors. 

Capillary electrophoresis (CE) methods for pharmaceutical quality control (QC) analysis are developed and applied in early to late phase of development. Although there are many application areas in early development as will be covered in other chapters of this book, this chapter will emphasize the late phase development of low-molecular-weight compounds. Nevertheless, the approaches that are discussed for late phase development may also be applied for early methods and to high-molecular-weight compounds. 

Table 12 gives an orientation help for CE separations sorted by pharmaceutical substances published in review articles. As this chapter focuses on the technical development of drug substances and products, only drug substances and drug formulations are covered. A useful compendium of CE applications in the pharmaceutical environment can be found in the book Capillary Electrophoresis Methods for Pharmaceutical Analysis written by G. Lunn. The book covers more than 700 active pharmaceutical ingredients and contains short method descriptions, sample preparation steps, and references. 

In Table 1, the typical validation parameters required for the different types of analytical procedures are listed. For all these analytical procedures CE might be an appropriate analytical technique. In fact numerous validated CE methods for pharmaceutical analysis have been described in literature during the last decade.In Table 2, an overview is listed of the ICH validation parameters included in several reported CE validation studies. Since chiral purity determination is an important application area of CE methods, this test is listed separately as a specific analytical procedure. In addition, the determination of drug counterions has been included as a separate application. This overview illustrates that in general the required validation parameters are addressed in reported CE validation studies. It should be noted, however, that the validation parameters included in Table 2 are not necessarily evaluated exactly according ICH requirements in the reported references. Many pharmaceutical companies apply a phase-related validation approach in which the depth of validation depends on the clinical phase of development of the product involved. 

T. Mirza, Q. Liu, R. Vivilecchia, Y. Joshi, Comprehensive validation scheme for in situ fiber optics dissolntion method for pharmaceutical drug product testing, J. Pharm. Sci., 98(3), 1086-1094 (2009). 

Shabir, G. A. Validation of high-performance liquid chromatography methods for pharmaceutical analysis. Understanding the differences and similarities between validation requirements of the U S Food and Drug Administration, the US Pharmacopeia and the International Conference on Harmonization. 

G. Lunn and N. Schmuff. HPLC methods for pharmaceutical analysis. Wiley Interscience. 

Figure 4.12. Configuration of large-scale, cell cultivation methods for pharmaceutical scale production...

Lunn. G. Capillary Elet tmphoresis Methods for Pharmaceutical Analysis. John Wiley Suns. Inc, New York. NY. 1999. 

---