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The Value of Near Infrared Spectroscopy in a Small Hospital Compounding Unit to Control the Risks Associated with Raw Materials

Author(s):  Storme-Paris Isabelle, Storme Thomas, Thauvin Maxime, Brion Francoise, Chaminade Pierre, Rieutord Andre

Issue:  Jan/Feb 2009 - Compounding for Pediatrics
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Abstract:  Pharmaceutical products, including capsules, oral suspensions, and solutions, are prepared by hospital pharmacists if no commercial product is available. Identification of the raw materials is a regulatory requirement before manufacturing (compounding). Because of the standard methods used, however, this is often time-consuming and laborious in a hospital setting. This article describes the use of near infrared spectroscopy in combination with chemometric methods for discrimination of raw materials. Sixty-three pulverized powder samples were discriminated by using reference samples (identity guaranteed by supplier and confirmed by mid infrared analyses) and NIRCal cluster analyses. A routine expert application involving optimized calibrations (n = 6) was developed, which allowed a rapid and nondestructive release procedure for every powder-based raw material received. This technique is superior to established identification analyses because of reduced quarantine times and cost savings.

Related Keywords: Isabelle Storme-Paris, DPharm, PhD, Thomas Storme, DPharm, PhD, Maxime Thauvin, DPharm, Francoise Brion, DPharm, PhD, Pierre Chaminade, DPharm, PhD, Andre Rieutord, DPharm, PhD, raw materials, quality standards, near infrared spectroscopy, analytical testing, hospital pharmacy

Related Categories: EXCIPIENTS, LEGAL, PEER-REVIEWED, TECHNOLOGY, QUALITY CONTROL, HOSPITAL PHARMACY

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