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Acceptance Criteria
Q6A Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances — Step ...
Accelerated Testing
Studies designed to increase the rate of chemical degradation and physical change of an active pharmaceutical ingredient or finished pharmaceutical ...
Hausner Ratio
Hausner ratio is a simplest method to measure powder flow properties. It is a ratio of a powder’s tapped bulk ...
Carr’s Index or Compressibility Index
Carr’s index is an indicator of the compressibility of powders. It can be determined by measuring both the bulk volume ...
Rheology
Rheology is the study of flow, addresses the viscosity characteristics of powders, fluids, and semisolids. Materials are divided into two ...
Angle of Repose
The angle of repose is a relatively simple technique for estimating the flow properties of a powder. It can easily ...
Micromeritics
Micromeritics is the science of small particles; a particle is any unit of matter having defined physical dimensions. It is ...
Buffer Capacity
pH, buffers, and buffer capacity are especially important in drug product formulation, since they affect the drug’s solubility, activity, absorption, ...
pKa or Dissociation Constants
Among the physicochemical characteristics of interest is the extent of dissociation or ionization of drug substances. This is important because ...
Partition Coefficient
A partition coefficient is the ratio of concentrations of a compound in a mixture of two immiscible solvents at equilibrium. ...