International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
A limit above (>) which an impurity should be identified. 
An impurity for which a structural characterization has been achieved. [12, 15]
The uniqueness of an excipient demonstrated by its physio-chemical properties. 
Inactive Ingredient Database
The receptacle used solely for the transportation of the inert ingredient commodity in bulk or in quantity to manufacturers, packers, processors or distributors. 
Allows the drug to dissolve in the gastrointestinal contents, with no intention of delaying or prolonging the dissolution or absorption of the drug. 
Containers that provide a permanent barrier to the passage of gases or solvents, e.g., sealed aluminum tubes for semi-solids, sealed glass ampoules for solutions. 
The act of bringing or causing any goods to be brought into a customs territory (national territory, excluding any free zone). 
An undesirable material found in an excipientas a consequence of the raw materials, excipient manufacturing process, or excipient degradation.
A description of the impurities present in the excipient.
Checks performed during production to monitor and, if appropriate, to adjust the process to ensure that the intermediate or excipient conforms to its specification. [1, 3]
Tests performed during the manufacture of an excipient, drug substance or drug product, rather than the tests that are conducted for finished product release.
An in vitro equivalence test is a dissolution test that includes comparison of the dissolution profile between the multisource product and the comparator product in three media: pH 1.2, pH 4.5 and pH 6.8. 
A dissolution test procedure identified in the pharmacopoeia, generally a one time point dissolution test for immediate-release products and a three or more time points dissolution test for modified release products. 
An FDA database containing information on excipients present in FDA approved drug products. 
International Nomenclature of Cosmetic Ingredients and Handbook. 
International Nomenclature of Cosmetic Ingredients as defined in the Cosmetic, Toiletry and Fragrance Association?s (CTFA) publication, the Cosmetic Ingredient Dictionary and Handbook. 
Generally the pharmaceutical product which was first authorized for marketing (normally as a patented product) on the basis of documentation of efficacy, safety and quality according to requirements at the time of the authorization. When a substance has been available for many years, it may not be possible to identify an innovator pharmaceutical product. 
The introduction of new technologies or methodologies. 
Generally the pharmaceutical product which was first authorized for marketing (normally as a patented product) on the basis of documentation of efficacy, safety and quality according to requirements at the time of the authorization. When a substance has b
Confirmation the item is installed to the supplier or user requirements or expectations.
The range set based on the desired target.
Functional equivalent in all respects to the original source material. 
Material that must undergo further manufacturing steps before it becomes an excipient. [1, 3]
Intermediate precision expresses within-laboratories variations: different days, different analysts, different equipment, etc. 
Partly processed product that must undergo further manufacturing steps before it becomes a bulk product. [17, 20]
Studies conducted at 30°C/65% RH and designed to moderately increase the rate of chemical degradation or physical changes for a drug substance or drug product intended to be stored long term at 25°C. 
International Chemical Reference Substances (ICRS) are primary chemical reference substances established on the advice of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. They are supplied primarily for use in physical and chemical tests and assays described in the specifications for quality control of drugs published in The International Pharmacopoeia or proposed in draft monographs. The ICRS may be used to calibrate secondary standards. 
The shortened scientific name based on the active ingredient. WHO is responsible for assigning INNs to pharmaceutical substances. 
A route of administration where the drug product is injected into a muscle. 
A route of administration where the drug product is injected into the abdominal cavity. 
A route of administration where the drug product is injected into a vein. 
International Pharmaceutical Excipients Auditing, Inc. 
International Pharmaceutical Excipients Council
International Pharmaceutical Excipients Council and the Pharmaceutical Quality Group
International Organization for Standardization. 
The International Organization for Standardization?s family of standards on environmental management Site and Supply Chain Security Overview ? Section 4