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IRON CARBOXYMALTOSE - Coggle Diagram
IRON CARBOXYMALTOSE
API DMF SPECIFICATIONS
Identification IR XRD - Nikel DMF
pH
Molecular Weight ( GPC )
Organic Volatile Impurities - Residual Solvent ;(Methanol ) GC
Water Content ( Coulometric Titration )
Sodium Chloride Content
Elemental Impurities ( ICP-MS) Arsenic Mercury Cadmium Lead Cobalt Nickel Vanadium Chromium
Inorganic Impurities Fe(II) Limit - Polography (Fe(II)-Fe(III) ratio
Organic Impurities Method1 ( Glucose -Maltose ) Method 2- UV - Total Impurities
Dextrin Content
Assay of Iron
Particle Size Distribution
DMF VALIDATION ANALYTICAL PROCEDURE
Acetaldehyde content by UPLC
ASSAY OF IRON
Benzene content by GC
Dextrin content by HPLC
Elemental Impurities by ICP-MS
Identification by XRD
Formaldehyde content by GC
DMF CHARACTERIZATION