CRED Getting the CMC Dossier Right 2024

Test Parameter Characterisation Appearance

Requirements

Method

Powder

Colour

White to cream

Identification IR spectrum Melting Point

Must Comply 114 to 117

TP489123 TP489187

Appearance of Solution Opalescence

Clear

TP489764 TP489832 Ph.Eur.2.2.7 Ph.Eur.2.4.14 Ph.Eur.2.4.8

Colour

Colourless Max 0.5% Max 0.1% Max 10ppm

Loss on Drying Sulphated Ash Heavy Metals

Related Substances Ph Eur Imp A B C D E Max 0.5% Any other unidentified impurity Max 0.2% Total Impurities Max 1.0% Residual Solvents

TP489788

TP489882

Benzene

Max 2ppm Max 500ppm Max 100ppm

Petroleum fraction

n-Hexane Content

TP489920