The compatibility of the drug substance with the excipients listed in 3.2.P.1 should be discussed. Additionally, key physicochemical characteristics (eg, water content, solubility, particle size distribution, polymorphic or solid state form) of the drug substance that can influence the performance of the drug product should be discussed.

For combination products, the compatibility of drug substances with each other should be discussed.

The choice of excipients listed in 3.2.P.1, their concentration, and the characteristics that can influence the drug product manufacturability and performance should be discussed relative to their respective functions.

• Drug product description including difference or similarity between the drug product and reference product, if applicable
• Propose route of administration (include any dilution or reconstitution necessary)
• Choice of manufacturing process, explain choice if alternative process could have been applicable (e.g. aseptic processing instead of terminal sterilization, direct compression instead of granulation). If different processes were used for different formulation highlight and explain differences, refer at 3.2.P.2.3. If no change in the process occurred refer to 3.3.P.3.3 and avoid duplication data.

Table 1 - Formulation history for Stelbatolol

Summary of the formulation developmental studies conducted are provided in Table 2

Table 2 - Formulation Development Studies

Summary of the risk assessment for product...

Text for the risk assessment of elemental impurities in the product