Application Notes

Estimating Return on Investment with
   Portable Raw Material Identification

Written by: Dan Klevisha, Polychromix, Inc.

Moving raw material identification testing out of the laboratory and into the warehouse can save valuable time and money. The PHAZIR^TM handheld NIR system even makes possible 100% identification inspection, while simultaneously reducing the cost of testing compared to conventional laboratory based testing systems.

Detecting Counterfeit Pharmaceuticals using    Handheld Near-Infrared Spectroscopy

Written by: S. Assi, R. Watt and A. Moffat, The School of Pharmacy, University of London

Pharmaceutical counterfeiting is a critical issue accounting for 10% of the world market by revenue. The impact of pharmaceutical counterfeiting can be counted in monetary loss, delayed healing, and increased morbidity and mortality. The World Health Organization and national regulatory agencies worldwide attempt to identify and prevent the sale of potentially lethal counterfeits. The problem is complex because of the vast number of pharmaceutical formulations, global manufacturing and buying patterns and the wide variety of counterfeiting techniques.

Using    Handheld near-infrared spectroscopy    used as an authentication technology for    pharmaceuticals

Written by: F.G. Haibach

Near infrared diffuse reflectance is a rapid, non-invasive method of investigating pharmaceutical raw materials and finished forms. The use of near-nfrared to distinguish placebo and active formations is over 15 years old. It is not suprising that in early 2001 a few independent groups presented results for counterfeit identification.

Identification of Hydrate Raw Materials

Written by: S. K. Schreyer and F. G. Haibach

NIR spectroscopy has wide applicability in the pharmaceutical process, from incoming inspection through to final product evaluation. As an integral part of PAT, the use of a portable handheld inspection unit such as the PHAZIRTM, can rapidly evaluate incoming materials. Along with material identification, the PHAZIR can also evaluate physical and chemical properties. In this application we present a method to determine the phase state of a sugar, as part of an incoming inspection of material.

At-line Blend Analysis Using Handheld    Near-Infrared Spectroscopy

Written by: F. G. Haibach and S. K. Schreyer

Near-infrared (NIR) spectroscopy is a powerful tool for assessing the homogeneity of industrial powder blends. In this study, blend homogeneity was followed on a small scale, using a commercial blender. Small-scale blending trials can form the basis for determining the scale of variability in a fully blended product. With some additional effort, other measures of blend uniformity can be implemented.

Identification of Particle Size of Excipients

Written by: S. K. Schreyer and F. G. Haibach

NIR spectroscopy has wide applicability in the pharmaceutical process, from incoming inspection through to final product evaluation. As an integral part of PAT, the use of a portable handheld inspection unit such as the PHAZIRTM, can rapidly evaluate incoming materials. Along with material identification, the PHAZIR can also evaluate physical and chemical properties. In this application we present a method to determine the particle size of a common excipient, as part of an incoming inspection of material.

Evaluation of Tablet Coating Thickness

Written by: S. K. Schreyer and F. G. Haibach

At-line analysis using portable instrumentation can provide rapid diagnostics off processes. Near-infrared haas been shown to bee rapid, non-destructive, accurate and precise method off measuring many parameters within the manufacturing process of tablets. Measuring coating thickness is a type off meassurement that handheld NIR instruments aare particularlyy suited for. Near-infrared measurements can probe the thickness of the coating on both tablet faces independently. This type of information allows for rapid monitoring andd adjustment of several coaters.

Satisfying GMP with Handheld Near-Infrared    Analyzers in the Pharmaceutical Industry

Written by: Dr. F.G. Haibach

Identification and qualification of incoming pharmaceutical raw materials as well as properties of finished forms can be rapidly determined. Handheld near-infrared analyzers significantly enhance workflow and productivity.

Determination of Moisture Content in    Pharmaceutical Raw Materials.

Written by: Dr. Suzanne Schreyer & Dr. F.G. Haibach

Moisture content determination is important for the processing of many powders. Powders have a large surface area and can absorb a large fraction of water by weight. The absorbed water changes the interactions between individual particles changing the way the powder processes. Water changes the flow, compaction and response to heat of the material. Hygroscopic materials, like sugar, starch and, to a lesser degree, cellulose can absorb relatively large quantities of water.

InfraTrac and the Polychromix PHAZIR^TM   Combating Counterfeit Pharmaceuticals:
   A Tag and Track Solution

Written by: Dr. Sharon Flank, University of Maryland School of Pharmacy

Companies need reliable ways to ensure the integrity of the pharmaceutical supply chain. Patients are in danger from counterfeiting and diversion, errors, and impure or counterfeit ingredients.