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Reconstitution is the process of adding a liquid diluent, or solvent, to a powdered medication, or solute, and then dissolving the medication to form a solution. The purpose of this study is to demonstrate that the reconstituted and diluted drug product does not promote the microbial growth, when reconstituted and stored under different conditions, for different time points as required. To evaluate the stability, the reconstituted drug is challenged with microbial ingression, in comparison with test control.
Quantifying the total number of microorganisms present in pharmaceutical products, including raw materials, intermediates, and finished products.
Analyze pharmaceutical products for specified or objectionable microorganisms and characterizing specific microbial contaminants to ensure accurate risk assessment and quality control.
Utilizing validated techniques such as membrane filtration, plate count, and most probable number (MPN) methods, in compliance with USP and other relevant guidelines.
Ensuring adherence to international standards and regulatory requirements, including those set by the USP, EP, and JP, for microbial limits in pharmaceutical products.
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