Raw Material Analysis for APIs and Excipients

STERIS Laboratories provides active pharmaceutical ingredients and excipients testing for the pharmaceutical industry.

No pharmaceutical product can be manufactured without first using raw material analysis to establish the identity, purity and quality of the raw materials to ensure the product is suitable for its intended use. When this critical step in the pharmaceutical manufacturing process is performed successfully, costly production problems and delays can be avoided.

STERIS Laboratories has years of experience performing all types of raw material analysis for active pharmaceutical ingredients. We offer compendial testing and raw materials analysis, and we can also test to Customer-supplied or vendor supplied methodology.

Physical and chemical raw material analysis

  • Boiling point
  • Clarity and degree of opalescence of liquids
  • Conductivity
  • Degree of coloration of liquids
  • Density of solids
  • Distillation range
  • Drop point
  • Elemental analysis (atomic absorption, atomic emission, graphite furnace, hydride system)
  • Freezing point
  • Identification testing
  • Infra red spectrometry
  • Limit tests
  • Melting point
  • Optical rotation
  • Osmolality
  • pH
  • Potentiometric determination of pH
  • Refractive index
  • Relative density
  • Residual testing (sulphated ash and total ash)
  • Titration (amperometric, complexometric and potentiometric)
  • UV-VIS spectrometry
  • Viscosity (capillary and rotating)
  • Water determination (loss on drying and Karl Fisher)

Chromatography

  • Gas chromatography with FID
  • High performance liquid chromatography (HPLC) with UV, PDA, RI detection
  • Size exclusion chromatography
  • Thin layer chromatography
  • Ultra-performance liquid chromatography with UV detection

Assays

  • Acid value
  • Ester value
  • Hydroxyl value
  • Iodine value
  • Peroxide value
  • Saponification value
  • Gas chromatography
  • High performance liquid chromatography
  • Titrations
  • Ultra-performance liquid chromatography

Impurities

  • Ethylene oxide and dioxan
  • Gas chromatography
  • High performance liquid chromatography
  • Particulate matter
  • Residual solvents
  • Ultra-performance liquid chromatography
  • Atomic absorption, atomic emission, graphite furnace, hydride system

Microbiological analysis

  • Absence of specific micro-organisms
  • Bioburden, TAMC and TYMC
  • Endotoxin testing (gel clot method, kinetic turbidimetric method)
  • Microbiological assay of antibiotics
  • Sterility testing

Raw material analysis is used for:

  • Pharmaceuticals
  • Medical device
  • Cosmetic industries.

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 Raw Material Analysis