AssureNMR™ HeparinFully Automated Material Screening

Impurities and adulterants are a potential liability and are a source of production delays when present in the manufacturing of pharmaceutical APIs, drug products, dietary supplements and chemical prod-ucts. Increased reliance on a global supply chain amplifies the need for QC screening of materials prior to use in manufacturing processes and at the final product. Effec-tive screening where unknown adulter-ants may occur requires both compound specificity and non-targeted methods. AssureNMR is a material validation system that provides a fully automated solution for screening against adulterants, degradants and impurities in your raw materials. It also determines if unknown materials are pres-ent during the screening process.Designed for use in GxP environments,

AssureNMR provides a traceable record of sample analysis and results. Applications include pharmaceutical, dietary supplements, chemical production, and analytical reference standards.

Corporate Benefits�� Reduce QC Material Validation time for production�� Identifies unknown material in the analysis�� Reduce production costs and delays due to material waste from bad batches�� Enhance product safety and limit liability exposure�� Available as a low cost renewable annual license or 15 year license

Method Benefits:�� Validate materials with one measurement�� Fully customizable�� Designed for production by lab technicians�� Automated calibration maintenance �� Results and reports available in minutes

NMR ScreeningInnovation with Integrity

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AssureNMR Heparin software provides fully automated screening of Heparin Sodium, the highly successful blood anticoagulant. Based on the revised USP Heparin Sodium monograph (USP32: Pharmacopeial Forum 35(5)), the fully automated test identifies heparin and analyzes for oversulfated chondroitin sulfate (OSCS), as well as other con-taminants to provide a comprehensive analysis and report of the material in just 15 minutes.

Based on NMR technology, AssureNMR Heparin includes a NMR spectral database and acquisition and analysis algorithms for the evaluation of Heparin Sodium. AssureNMR Heparin is an analy-sis module for AssureNMR software for material validation.

Automated AnalysisAll components within the USP search regions described in the Monograph are quantified and totaled. Successful samp-les have less than the designated integral (4% or 200%) in these regions.

�� Automated Heparin Sodium screening�� Identities potential contaminants such as OSCS and residual solvents�� Spectral database at 500MHz�� Automated report showing test results�� GLP/GMP compatible�� Available as a renewable annual license or 15 year license