Important Terminologies Used During Impurities Studies as Per ICH Guideline

 

Important Terminologies Used During Impurities Studies as Per ICH Guideline

—  Chemical Development Studies:

—  Studies carried out during the development, optimization, up gradation and validation of a new chemical entity or drug.

—  Impurity:

—  A drug product, or any entity that is not a component of formulation ingredient.

—  Impurity profile:

—  Detailed presentation of identified and unidentified impurities associated with a new drug substance.

—  New drug substance:

—  A therapeutic substance developed for the 1^st time and that is not registered previously as a therapeutic entity. It may b a complex, ester form or salt form of already registered drugs. It is also called as new molecular entity or new chemical enetity.

—  Starting material:

—  A material used in the synthesis of new drug substance is called starting material. They are commercially available and of known physical and chemical properties.

—  Intermediate:

—  Any entity formed or produced during the step by step manufacturing of newly developed drug is termed as intermediate. Before it develops to new drug entity it has undergoes some chemical transformation.

—  Ligand:

—  Any substance that posses strong affinity towards a metal ion.

—  Identified impurities:

—  Any impurity that has known structural characterization is termed as identified impurity.

—  Unidentified impurities:

—  Any impurity the structural characterization of which is unknown and is defined by qualitative analytical techniques like HPLC retention time is termed as unidentified impurity.

—  Specified impurities:

—  Any identified or unidentified individual impurity which has proper limits of acceptance criteria and is listed in the specifications given to a newly developed drug is termed as specified impurity.

—  Unspecified impurities:

—  Any impurity that is included in the general acceptance criteria limitations but have no individual acceptance limits in the specifications allotted to a newly developed drug.

Maximum Daily Dose	Reporting Threshold	Identification Threshold	Qualification threshold
≤ 2g/day	0.05%	0.10% or 1mg/day	0.15% or 1mg/day
˃ 2g/day	0.03%	0.05%	0.05%