Dissolution testing is a requirement for solid oral dosage forms throughout the development life-cycle and commercial manufacturing. Our services for dissolution testing help understand the process in which a substance forms a solution and measures the extent and rate of solution formation from a dosage form, such as tablet, capsule, ointment, etc.
The dissolution studies help to identify the significant changes (change of dosage form, qualitative formulation changes) likely to require bioequivalence studies and demonstrate the similarity between batches. Also, to determine the changes in the manufacturing process/excipient change (minor).
Our scientific team have experienced to analyze and report the results as per current regulatory requirements.
A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate the performance of the product. General chapter <711> Dissolution includes four standardized devices: basket, paddle, reciprocating cylinder, and flow-through cell. devices: basket, paddle, reciprocating cylinder, and flow-through cell.
The release of the drug can be analyzed by UV or HPLC instruments.
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