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    Drug Fraud

Pharmaceutical

The pharmaceutical industry places high demands on instrument manufacturers. Highest accuracy, speed, sophisticated automation, unsupervised operation, low maintenance, and absence of downtime are required in this high value product market. Over many decades of production of dedicated analytical instrumentation for the pharmaceutical industry, Elementar has listened and has learned from its market-leading customers. Through patented technology we have optimized our elemental analyzers for delivering the right results with the highest possible convenience.

CHNOS combustion analysis for product quality control

The concentrations of carbon, hydrogen, nitrogen, oxygen and sulfur in pharmaceutical products often serve as important parameters for quality control of the production process. The concentration of an active substance with a specific elemental composition which is mixed into a carrier material with a different elemental composition can for example easily and cost-efficiently be detected by means of elemental analysis.

Industry-leading analytical performance

Through quantitative high temperature combustion followed by patented cleaning and gas separation technology, solid or liquid substances are quantitatively converted into gaseous compounds and measured by efficient detectors with a precision and accuracy of up to ± 0.1 % relative. There is no technology which is more accurate in the determination of the concentrations of carbon, hydrogen, nitrogen, oxygen and sulfur.

 

Regulated environments in the pharmaceutical industry

To adapt to the special needs which regulatory bodies impose on manufacturers in the pharmaceutical industry, Elementar provides special optional features like uninterruptible power supply, software compliant to 21 CFR part 11 and installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). System uptime and ease of use is guaranteed through sophisticated self-diagnosis, tool-free maintenance and full automatization for remote and unattended operation.

1 results:

Isotopic ratios to detect infringements of patents or proprietary processes of pharmaceuticals: Two case studies
Journal of Pharmaceutical and Biomedical Analysis (2008)
E. Deconinck, a. M. van Nederkassel, I. Stanimirova, M. Daszykowski, F. Bensaid, M. Lees, G. J. Martin, J. R. Desmurs, J. Smeyers-Verbeke, Y. Vander Heyden

Because of the increasing problem of drug counterfeiting and the potential danger related as well as the economic losses involved, the pharmaceutical industry and the regulatory instances are interested in the development of anti-counterfeiting and patent protection methodologies. In this paper, the evaluation of measured isotopic ratios by means of explorative chemometric techniques was performed to distinguish groups in two data sets containing samples of acetyl salicylic acid and ibuprofen, respectively. The samples in the data sets originated from different countries and manufacturers. For both compounds a clear distinction of groups of samples could be obtained. These groups could be explained based on the origin of the samples, both geographically as well as based on the manufacturer. Hypotheses were formulated concerning the synthetic pathways of the molecules and they were linked to the groups obtained with the chemometric tools. ?? 2008.
Tags: C , H , ph , cr , EA