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Others

Chemical Analysis has vast experience in a large variety of sample analyses, ranging from routine pharmacopeial analysis to in depth problem solving. We offer a complete service of analytical testing, from method development to validation through to routine analysis. Whether a raw material, finished product or anything in between, Chemical Analysis has the solution to your analysis needs.

  • Pharmacopeial analysis (BP, Ph Eur, USP) via AAS or ICP-OES
  • USP <232> and  <233>
  • Extractable metals
  • Non-compendial analysis of raw materials and finished products
  • Product registration testing
  • Manufacturing process validation testing
  • Extensive experience in large variety of sample matrices
  • Raw materials
  • Finished products (pharmaceutical drugs and complementary medicines, veterinary medicines)
  • Industrial samples
  • Highly sensitive (ppb detection)
  • Various digestion techniques via microwave, leaching or acid digestion
  • Method transfer
  • Method verification as per USP <1226>
  • Full method validation to ICH guidelines
  • In-process and stability samples
  • Low level analysis for arsenic contamination (VGA)
  • Investigations
  • Identification of unknown contamination in manufacturing processes
  • Batch to batch variations
  • Reverse engineering of market leaders
  • Comparison of compositions to existing patents
  • Chemical, physical, stability comparisons against market leaders
  • Comprehensive comparison of APIs or excipients from different suppliers
  • Production stage reactor and product contamination
  • Post-production product contamination or degradation
  • New product process issues
  • Effect on product of planned and unplanned component and process changes
  • Leachables and extractables to and from packaging
  • Product recall investigations
  • Identification of degradants in stability samples
  • Stability indicating method development and validation
  • Method transfer, development, improvement, validation
  • GMP certified, FDA inspected
  • TGA/APVMA licensed
  • ICH and PIC/S compliant