ACTIVE PHARMACEUTICAL INGREDIENT

API PRESENTATTION
Some Definitions-
Active Pharmaceutical Ingredient (API): A substance or compound that is intended to be used in the manufacture of a pharmaceutical product as a therapeutically active compound (ingredient)

Enantiomers: cpds with same molecular formula as substance but differ in spatial arrangement of atoms and are non-superimpossable mirror images

Polymorphism:
Occurrence of different crystalline forms of the same substance

Degradation product :
Molecule resulting from chemical change in substance due to e.g. light, temperature, pH, water, reaction with excipient, immediate container/closure

Impurity:
Any component of the medicinal product which is not the chemical entity defined as the active substance or an excipient of the product

Identified Impurity:
An impurity for which structural characterisation has been achieved

Unidentified degradation product:
An impurity defined only by qualitative properties e.g. Rt
Abbrevations:
BP British Pharmacopoeia
CEP EU certificate of suitability
EOI Expression of interest
FDC Fixed dose combination
FPP Finished pharmaceutical product
GMP Good manufacturing practices
ICH International Conference of Harmonization
Int.Ph. International Pharmacopoeia
Ph.Eur. European Pharmacopoeia
USP United States Pharmacopeia Information on API:
Applicants should collect and analyse available information of the API in a systematic approach. This approach
 Leads to a sound scientific understanding of the API, with respect to properties, stability, specifications, etc.
 Assists in API manufacture and DMF compilation
 Leads to the appropriate choice of API manufacturer (source)
 Assists in dossier compilation
 Is important for FPP pharmaceutical development
 Leads to reduction of time / cost Literature Information on API;
Standard works / series / books – such as: