Stability, testing technologies

Electrokinetics. Electrokinetics is a tested technology that has been used for over half a century to dewater and stabilize soils, and has recently been investigated for in situ use at hazardous waste sites (23). Primarily used for metals removal, the technology utilizes an electrical field to generate a flow and concentration gradient in porous and semiporous soils. 

Matsuo was the principal compiler of information for the Research and Technology Committees for Drug Standards, the Osaka Pharmaceutical Manufacturers Association and the Pharmaceutical Manufacturers Association of Tokyo s Basic Study on Establishing a Light Stability Testing Method both basic study and draft Light Stability Test. This information was published by Yatani et al. (288). 

Abstract Spectroscopic methods such as NIR, Fourier transform infrared, and Raman are becoming increasing important in pharmaceutical research and manufacturing. This chapter reviews both quantitative and qualitative applications of spectroscopic analysis for pharmaceutical products. Several applications of these technologies to stability testing are discussed. 

Spectroscopic methods can provide fast, non-destructive analytical measurements that can replace conventional analytical methods in many cases. The non-destructive nature of optical measurements makes them very attractive for stability testing. In the future, spectroscopic methods will be increasingly used for pharmaceutical stability analysis. This chapter will focus on quantitative analysis of pharmaceutical products. The second section of the chapter will provide an overview of basic vibrational spectroscopy and modern spectroscopic technology. The third section of this chapter is an introduction to multivariate analysis (MVA) and chemometrics. MVA is essential for the quantitative analysis of NIR and in many cases Raman spectral data. Growth in MVA has been aided by the availability of high quality software and powerful personal computers. Section 11.4 is a review of the qualification of NIR and Raman spectrometers. The criteria for NIR and Raman equipment qualification are described in USP chapters <1119> and < 1120>. The relevant highlights of the new USP chapter on analytical instrument qualification <1058> are also covered. Section 11.5 is a discussion of method validation for quantitative analytical methods based on multivariate statistics. Based on the USP chapter for NIR <1119>, the discussion of method validation for chemometric-based methods is also appropriate for Raman spectroscopy. The criteria for these MVA-based methods are the same as traditional analytical methods accuracy, precision, linearity, specificity, and robustness however, the ways they are described and evaluated can be different. 

Fig. 14.3 Atlas SUNTEST CPS/CPS+ photo-stability chamber, ICH option I (Courtesy of Atlas Material Testing Technology LLC)...

In order to solve this chemical stability problem, a new proprietary PFSA ionomer synthesis procedure has been developed at DuPont that results in a reduction of the reactive end groups. This approach has been referred as chemical stabilization (CS) technology. Fluoride emission from chemically stabilized polymer in a Fenton s test was found to be eight times lower than a nonchemically stabilized polymer. 

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