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