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Pharmaceutical and Veterinary

Chemical Analysis provides expert analysis in all areas of pharmaceutical and veterinary testing and analysis of raw materials, finished products, stability testing, active assays, related substances and impurities. We are TGA and APVMA licensed providing a plethora of chemical, physical and microbiological analytical services to the pharmaceutical (ranging from drugs, OTC and complementary medicines including chemical testing of medical devices) and veterinary industries.

  • Current BP, EP, USP, FCC, AOAC
  • Identification by FTIR-ATR, wet Chemistry based methods, NMR
  • Water Content (titrator, coulometric and coulometric oven analysis)
  • Residual Solvents (BP/EP/USP)
  • Finished Product Testing (APVMA, TGA, FDA)
  • Particle Size Analysis
  • Dissolution
  • Disintegration
  • Physical testing, Hardness, Thickness, Friability
  • Product Registration Testing
  • Manufacturing Process Validation Testing
  • Comparative Batch Analysis
  • Cleaning Validation Testing
  • Method Transfer, Verification and Validation
  • Sterility Testing by current BP/EP/USP/ISO
  • Microbiology  –  Non-sterile testing
  • Microbiology – Bacterial Endotoxin (LAL) Testing

Equipped with BioQuell VHP Generator and the latest sterility isolator model from Extract Technology, our sterility isolator is designed to perform sterility testing in an aseptic environment providing assurance of process integrity. Unlike traditional clean rooms where samples are introduced into the rooms directly with simple surface sterilization, samples introduced into our sterility isolator are decontaminated by a controlled Vapourised Hydrogen Peroxide (VHP) cycle. This ensures that the samples introduced are free of surface contamination. All of our sterility methods are validated initially and at the end of the sterility testing to ensure no false positive or negative results are given.

Chemical Analysis offers a comprehensive range of non-sterile pharmaceutical (including cosmetics, sunscreens, OTC and complementary medicines) testing and method validation (compliant to current BP, EP, USP, ICH and FDA requirements) which include the following analyses:

  • Total Aerobic Microbial Count (TAMC)
  • Total Yeast and Mould Count (TYMC)
  • Staphylococcus aureus
  • Bile Tolerant Gram-negative Bacteria (Enterobacteriaceae)
  • Pseudomonads and Pseudomonas aeruginosa
  • Coliforms and E.coli
  • Salmonella
  • Candida albicans
  • Clostridia
  • Bioburden
  • Biological Indicators (spore strips)
  • Preservative Efficacy Testing (PET, Efficacy of Antimicrobial Preservation)
  • Disinfectant Efficacy Testing
  • Pharmaceutical Water Testing
  • Microbiological Quality of Finished Products for Stability Studies
  • Environmental Monitoring (Air Sampling, Settle Plates, Contact Plates and Swabs)
  • Endotoxins are potentially toxic compounds released from the cell wall of Gram-negative bacteria that can be a potential health risk to humans. In large doses, Endotoxins can cause shock and death in humans.
  • Chemical Analysis can provide both quantitative and qualitative Bacterial Endotoxins Testing (BET, LAL) using turbidimetric and chromogenic methods. Our bacterial endotoxins testing methods and 21 CFR Part 11 compliant software comply with the current BP, EP, USP, and FDA requirements.