Analytical Pharmacy
Certificate of Analysis (COA)
A Certificate of Analysis (COA) is a document that certifies the quality and purity of a product or material. In ...
Specification
A list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria ...
Out of Expectation (OOE)
OOE refers to a result that is unexpected or deviates from typical patterns based on process, method, or equipment performance ...
Out of Specification (OOS)
OOS refers to a test result that falls outside the established acceptance criteria or specifications set by regulatory bodies or ...
Out of Trend (OOT)
OOT represents a result that, while within the specification limits, shows an unexpected trend or deviation compared to historical data ...
Buffer Capacity
pH, buffers, and buffer capacity are especially important in drug product formulation, since they affect the drug’s solubility, activity, absorption, ...