Drug Product Release Testing

Batch Release Testing and Analysis of Drug Products

STERIS Laboratories offers quality-controlled services for drug product testing while providing accurate analyses for time-sensitive drug products that are to be released and distributed to the commercial marketplace.

We are experienced in drug product analysis of all types of pharmaceutical products, including solid dosage forms (tablets, capsules, etc.), liquids and semi-solid products.

We understand the unique pressures and demands of the industry and deliver the exact drug product analysis support you need, quickly and cost efficiently.

We manage that all reference standards, reagents, equipment and methodologies for drug product analysis are in place to allow finished drug formulations to be manufactured and delivered to markets on time.

Drug product analysis includes:

  • Physical and chemical analysis
  • Apparent volume
  • Conductivity testing
  • Density
  • Disintegration testing pharmaceutical product resistance to crushing of tablets
  • Friability dissolution testing (apparatus I and II)
  • Neutralizing capacity
  • Optical rotation of drugs
  • Particle size (sieve and microscopy)
  • Particulate contamination, visible and sub-visible (light obscuration particle count test)
  • pH
  • Refractive index
  • Uniformity of dosage units (mass and content)
  • Uniformity of mass
  • Viscosity
  • Water content of compounds

Assays

  • Spectroscopy: UV-VIS, atomic absorption- and atomic emission spectrometry, graphite furnace, hydride system
  • Gas chromatography: (FID) liquid and headspace injection
  • High performance liquid chromatography (UV-VIS, PDA, RI)
  • Titration (amperometric, complexometric and potentiometric)
  • Ultra-performance liquid chromatography

Identification

  • Atomic absorption spectrometry / atomic emission spectrometry
  • Fluorimetry
  • FTIR
  • Liquid chromatography (high performance liquid chromatography, ultra-performance liquid chromatography) with UV-VIS, PDA, RI
  • TLC (HP) TLC
  • UV-VIS spectrometry

Impurities

  • Ethylene oxide residual solvents
  • Gas chromatography (FID)
  • High performance liquid chromatography (UV-VIS, PDA, RI)
  • Residual solvents
  • Thin layer chromatography (HP)TLC
  • Ultra-performance liquid chromatography (UV-VIS)

Microbiological analysis

  • Absence of specific micro-organisms
  • Bioburden, TAMC and TYMC
  • Disinfection tests
  • Endotoxin testing (gel clot method, kinetic turbidimetric method)
  • Microbiological assay of antibiotics
  • Preservative efficacy testing
  • Sterility testing
Available services vary between laboratories. Contact us to learn more about the services offered at each of our locations

Contact our team of experts to find out more about Drug Product Release Testing