Analytical Development

Major activities includes:

• Testing of API and Excipients as per Pharmacopeia and by In House Method

• Analytical Method Development for Assay, Dissolution and Related Substances

• Method Validation - for Assay, Dissolution and Related Substances

• Stability Studies as per ICH Guidelines

• Process Validation and Packing Validation

• Comparative Study with Innovator for various parameters as per Pharmacopeia and by In House Method

• Dissolution Testing

• Documentation for audit