QC Release Testing (Chemistry & Microbiology)
Determine preliminary solubility, stability, and other characteristics of API by performing pH/solubility, pH/stability, hydrophobicity, forced degradation, etc. studies in various solvents. These studies indicate the API’s general physical and chemical characteristics and if it can be formulated as a parenteral solution, emulsion, or suspension, and what excipients provide beneficial attributes to a formulation.
Singota’s Microbiology department supports testing (bioburden, bacterial endotoxin, and sterility) for the release of the product, microbiological testing on raw materials, and supporting phase appropriate microbial challenge studies (e.g. reconstituted lyophilized or multi-dose products).