Description

• General description: Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.Capecitabine is an orally administered drug belonging to the class of fluoropyrimidine carbamates. It converts into 5-fluorouracil (5-FU) at the tumor tissues by exploiting the high intratumoral concentrations of thymidine phosphorylase.[1]
• Application: Capecitabine may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography[2] and spectrophotometric[3] techniques.
• Biochem/physiol Actions: Capecitabine is an anti-cancer drug, a prodrug of doxifluridine, metabolized to 5-fluorouracil at the tumor site. The activation of capecitabine follows a pathway with three enzymatic steps and two intermediary metabolites, 5′-Deoxy-5-fluorocytidine (5′-DFCR) and 5′-Deoxy-5-fluorouridine (5′-DFUR), to form 5-fluorouracil.
• Analysis Note: These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.
• Other Notes: This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.
• Footnote: To see an example of a Certificate of Analysis for this material enter LRAA2199 in the slot below. This is an example certificate only and may not be the lot that you receive.