Complete Monograph

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Compendial (pharmacopeial) testing on materials used in the manufacturing of pharmaceuticals is a basic requirement for most regulatory submissions around the world. Established pharmacopeial monographs such as those from the US Pharmacopeia-National Formulary (USP/NF), the European Pharmacopoeia (EP), and the Japanese Pharmacopoiea (JP) provided standardized methods and specifications for pharmaceutical raw materials and finished products.

Infinity Laboratories has comprehensive analytical laboratory that offers USP/NF, EP and JP monograph testing for all raw materials and provides complete Qualification testing of Active Pharmaceutical Ingredients (API) and Excipients.
We also provide Residual Solvent Testing per current USP <467> and Client Specific validated methods for Raw Material and Finished Product Release as required by USP.

  • HPLC System with Autosampler for Potency Assays and Impurities
  • GC System with Autosampler and Headspace unit for Potency Assays, Residual Solvents and Impurities
  • Fourier Transmittance Infra Red (FTIR) Spectrophotometer for Identifications on Raw Materials
  • Ultra Violet and Visible (UV-VIS) Spectrophotometer for Identifications and Quantitative Assays
  • Dissolution Apparatus for Solid Dosage Drug Release
  • Refractometer for Refractive Index on Raw Materials
  • Total Organic Carbon (TOC) Analyzer for Total Organic Carbon Analysis
  • Conductivity Meter for Conductivity Measurements
  • pH Meter for pH Measurements
  • Melting Point Apparatus for Melting Range Measurements
  • Polarimeter for Specific Rotation and Optical Rotation Measurements
  • Brookefield and Kinematic Viscometers for Viscosity Measurements
  • Karl Fischer Titrators for Water by Karl Fischer Measurements

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