National Association of Chemical Distributors
The pure excipient, containing no other materials. 
The ability of a substance to cause adverse effects on the nervous system. 
A pharmaceutical product type, for example, tablet, capsule, solution, cream, etc., which has not previously been registered in a region or Member State, and which contains a drug ingredient generally, but not necessarily, in association with excipients.
The designated therapeutic moiety, which has not previously been registered in a region or Member State (also referred to as a new molecular entity or new chemical entity). It may be a complex, simple ester, or salt of a previously approved drug substance. [12, 15]
An excipient used for the first time in a drug product or a new route of administration.  Equivalent to "Novel Excipient".
An active pharmaceutical substance not previously contained in any drug product registered with the national or regional authority concerned. A new salt, ester, or non-covalent-bond derivative of an approved drug substance is considered a new molecular entity for the purpose of stability testing under this guidance. 
The highest dose of a substance that, in a given toxicity test, causes no biologically significant effects in the exposed test animals. 
The highest dose of substance at which there are no biologically significant increases in frequency or severity of any effects in the exposed humans or animals. 
refers to the component by which a particular excipient is named.
Material that does not meet the manufacturer?s specifications or has not been manufactured according to applicable GMPs. 
An analytical technique not found in compendia or other listings of official analytical methods. 
A non-fulfillment of a requirement defined within a quality management system.
The variability expected to be obtained for the excipient during typical processing and evaluation when the process operates in a state of control with no special causes of variation.
The declaration of specific nutritional components such as total calories, calories from fat , total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, iron.