U.S.P. Tests for Excipients

LYF Research manages the applicable USP tests for Excipients from among the following list:

DESCRIPTION

  • Labeling of Inactive Ingredients

IDENTIFICATION

  • Identification-Organic Nitrogenous Bases
  • Identification Tests- General
  • Spectrophotometric Identification Tests
  • Thin-Layer Chromatographic Identification Tests
  • Fats and Fixed Oils
  • Chromatography
  • Capillary Electrophoresis
  • Loss on Drying
  • Mass Spectrometry
  • Optical Rotation
  • Spectrophotometry and Light-Scattering
  • X-Ray Diffraction
  • Near-Infrared Spectrometry

ASSAY

  • Alginates Assay
  • Assay for Citric Acid/Citrate and Phosphate
  • Iodometric Assay- Antibiotics
  • Methoxy Determination
  • Sulfonamides
  • Titrimetry
  • Chromatography
  • Capillary Electrophoresis
  • Polarography
  • Spectrophotometry and Light-Scattering

 

IMPURITIES

Organic Impurities

  • 4-Epianhydrotetracyclines
  • Nitrogen Determination
  • Ordinary Impurities
  • Chromatography
  • Capillary Electrophoresis
  • Optical Rotation
  • Polarography
  • Spectrometry and Light-Scattering
  • Impurities in Official Articles

Inorganic Impurities    

  • Aluminum
  • Arsenic
  • Chloride and Sulfate
  • Heavy Metals
  • Iron
  • Lead
  • Mercury
  • Residue on Ignition
  • Selenium
  • Oxygen Flask Combustion
  • Plasma Spectrochemistry
  • Loss on Ignition

Residual Solvents    

  • Organic Volatile Impurities
  • Chromatography
  • Loss on Drying

 

SPECIFIC TESTS
 

Physicochemical Characterization    

  • Bulk Density and Tapped Density
  • Color Achromicity
  • Completeness of Solution
  • Congealing Temperature
  • Crystallinity
  • Density of Solids
  • Distilling Range
  • Loss on Drying
  • Melting Range or Temperature
  • Nuclear Magnetic Resonance
  • Optical Microscopy
  • Optical Rotation
  • Osmolality and Osmolarity
  • Particle Size Distribution Estimation by Analytical Sieving
  • pH
  • Powder Fineness
  • Radioactivity
  • Refractive Index
  • Specific Gravity
  • Specific Surface Area
  • Tensile Strength
  • Viscosity
  • X-Ray Diffraction
  • Biotechnology-Derived Articles
  • Near-Infrared Spectrophotometry
  • Phase-Solubility Analysis

Pharmaceutical Water

  • Titrimetry
  • Total Organic Carbon
  • Water Conductivity
  • pH

Functionality/ Safety/ GMPs

  • Acid-Neutralizing Capacity
  • Gel Strength of Gelatin
  • Powder Flow