I
ICH

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

Identification Threshold

A limit above (>) which an impurity should be identified. [15]

Identified Impurity

An impurity for which a structural characterization has been achieved. [12, 15]

Identity

The uniqueness of an excipient demonstrated by its physio-chemical properties. [7]

IID

Inactive Ingredient Database

Immediate Container

The receptacle used solely for the transportation of the inert ingredient commodity in bulk or in quantity to manufacturers, packers, processors or distributors. [7]

Immediate Release

Allows the drug to dissolve in the gastrointestinal contents, with no intention of delaying or prolonging the dissolution or absorption of the drug. [12]

Impermeable Containers

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. [13]

Importation

The act of bringing or causing any goods to be brought into a customs territory (national territory, excluding any free zone). [17]

Impurity

An undesirable material found in an excipientas a consequence of the raw materials, excipient manufacturing process, or excipient degradation.

Impurity Profile

A description of the impurities present in the excipient.

In-process Control / Testing

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]

In-process Tests

Tests performed during the manufacture of an excipient, drug substance or drug product, rather than the tests that are conducted for finished product release.

In-vitro Equivalence Test

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. [24]

In-vitro Quality Control Dissolution Test

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. [24]

Inactive Ingredient Database (IID)

An FDA database containing information on excipients present in FDA approved drug products. [4]

INCI

International Nomenclature of Cosmetic Ingredients and Handbook. [6]

INCI Name

International Nomenclature of Cosmetic Ingredients as defined in the Cosmetic, Toiletry and Fragrance Association?s (CTFA) publication, the Cosmetic Ingredient Dictionary and Handbook. [6]

Indicator

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. [24]

Innovation

The introduction of new technologies or methodologies. [11]

Innovator Pharmaceutical Product

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

Installation Qualification (IQ)

Confirmation the item is installed to the supplier or user requirements or expectations.

Intended Range

The range set based on the desired target.

Interchangeability

Functional equivalent in all respects to the original source material. [4]

Intermediate

Material that must undergo further manufacturing steps before it becomes an excipient. [1, 3]

Intermediate Precision

Intermediate precision expresses within-laboratories variations: different days, different analysts, different equipment, etc. [14]

Intermediate Product

Partly processed product that must undergo further manufacturing steps before it becomes a bulk product. [17, 20]

Intermediate Testing

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. [13]

International Chemical Reference Substance

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. [21]

International Nonproprietary Name

The shortened scientific name based on the active ingredient. WHO is responsible for assigning INNs to pharmaceutical substances. [25]

Intramuscular (i.m.)

A route of administration where the drug product is injected into a muscle. [7]

Intraperitoneal (i.p.)

A route of administration where the drug product is injected into the abdominal cavity. [7]

Intravenous (i.v.)

A route of administration where the drug product is injected into a vein. [7]

IPEA

International Pharmaceutical Excipients Auditing, Inc. [6]

IPEC

International Pharmaceutical Excipients Council

IPEC PQG

International Pharmaceutical Excipients Council and the Pharmaceutical Quality Group

IQ

Installation Qualification

ISO

International Organization for Standardization. [6]

ISO 14000

The International Organization for Standardization?s family of standards on environmental management Site and Supply Chain Security Overview ? Section 4 [6]