We know that every API and drug product presents its own issues. Whether you need a chromatographic method for API purity or drug product potency, a solid-state method for API or formulation process control, a stability indicating method for long term studies, a straight forward method for solvent content, or more challenging assays specific to your product, we have the expertise to provide the methods that you need. Our method development are specific to each technique and product. All methods are documented in detail for ready inclusion in regulatory documents or trouble free method transfers.
Typical methods development include:
• Stability Indicating Assay
• Content Uniformity
• QC/Biorelevant Dissolution
• Solid Form Determination