ADL Pellets

Define Objectives and Requirements: Clearly outline the purpose of the analytical methods. Determine what parameters need to be measured, such as assay potency, impurities, and dissolution profile. Understand regulatory requirements and industry standards.

Literature Review: Conduct a thorough literature review to understand existing methods and technologies relevant to pellet formulation analysis. Identify any gaps or areas for improvement.

Method Development:

• Select appropriate analytical techniques based on the properties of the pellet formulation. Common techniques include HPLC (High-Performance Liquid Chromatography), GC (Gas Chromatography), UV-Vis spectroscopy, etc.
  
• Optimize conditions such as mobile phase composition, column type, temperature, etc., for each method.
  
• Develop methods for impurity detection and quantification, ensuring sensitivity and selectivity.
  
• Establish dissolution methods to assess the release profile of active ingredients from the pellets.
  

Method Validation:

• Conduct method validation according to regulatory guidelines (e.g., ICH, FDA).
  
• Validate parameters such as specificity, accuracy, precision, linearity, robustness, and limit of detection/quantitation for each method.
  
• Perform forced degradation studies to assess method robustness.
  
• Ensure validation protocols are well-documented and reproducible.
  

Documentation and Reporting:

• Document all method development and validation activities in detail, including protocols, results, and any deviations encountered.
  
• Prepare comprehensive validation reports summarizing the methodology, results, and conclusions.
  
• Ensure documentation complies with regulatory standards and internal quality procedures.