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: 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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