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Greater certainty in monitoring 3 therapeutic medications is facilitated by new CRMs
Date:11/18/2009

Rockville, Md., November 18, 2009 To help bring greater certainty to the measurement of medication levels in a patient's bloodstream for three drugs with narrow therapeutic ranges, the U.S. Pharmacopeial Convention (USP) is releasing new certified reference materials (CRMs).

The three new CRMs are for carbamazepine, an anticonvulsant and mood stabilizing drug used primarily in the treatment of epilepsy and bipolar disorder; phenytoin, commonly used as an antiepileptic; and theophylline, used in the treatment of respiratory diseases. These three drugs are among a group of medicines that are often monitored in the bloodstream of patients that have been prescribed the drugs. Such medicines may need to be carefully monitored for a number of reasons, including a narrow therapeutic range or risk of toxicity. Therapeutic drug monitoring may also be necessary for drugs that are intended to maintain the absence (as opposed to the presence) of a medical condition, such as seizures.

CRMs represent an important step forward for USP reference standards, which are the physical materials used to demonstrate compliance to written USP standards designating a medicine and its ingredients' identity, quality, purity, strength and consistency. CRMs are reference standards accompanied by a certificate of analysis. A CRM is rigorously tested for one or more chemical or physical properties (such as purity). A property value with associated uncertainties certified to be true based on these tests is assigned to the CRM after a thorough statistical treatment of the data. The path of metrological traceability, which provides information on how the measurement was made and which standards were used to support the measurement, is included in the Certificate of Analysis, as well as the estimated level of uncertainty associated with the assigned value. This added information regarding uncertainties and traceability is provided for users of the reference materials. Procedur
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Contact: Francine Pierson
fp@usp.org
301-816-8588
US Pharmacopeia
Source:Eurekalert

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