cGMP/API manufacturing Analytical Support
Source: Ash Stevens
Ash Stevens has a dedicated and experienced analytical staff providing comprehensive analytical support spanning early stage development through commercial API manufacturing. We understand the importance of timely and quality analytical support to the success of your project. For this reason, we maintain a high ratio of analytical support to chemists and engineers on a project.
Ash Stevens analytical capabilities for the support of cGMP/API manufacturing processes include:
- Methods development
- Methods validation
- Specification development/material testing
- Structural analysis
- Impurity isolation and identification
- Product characterization and purity assessment (HPLC, GC, GCMS, LCMS, Heavy Metals, Karl Fischer)
- ICH stability studies (storage and testing)
- Reference standard qualification
- API solids characterization
- Cleaning method development and validation
- Test and release of starting materials, intermediates and final products
- Impurity profiling
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