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- Active Ingredient / Impurity Analysis
- Active Ingredient Profiling
- Five Batch Analysis
- Method Development and Validation
- Physical and Chemical Analysis
- Product Formulation
- Residue Analysis and Field Studies
- Storage Stability Studies
Method Development and Validation
Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for sample release data, testing of stability samples, testing of active ingredients and to provide data to support specifications.
For the assay of the active ingredient we would normally validate the method used in-house, such validation being designed to meet the requirements of SANCO/3030/99 rev.4. Alternatively, and only if applicable, we would try to find a published method such as CIPAC and AOAC, which is generally acceptable with only a limited validation.