Laboratory Test Request Details

Pharmaceuticals Test Request

Request: 18-01853

Status: Lab Needed

Closes: 02/12/2019

Title:

API Colloid Particle Characterization Analyses

Description:

Pharmaceutical Laboratory needed for the following Active Pharmaceutical Ingredient API analyses 1. Colloid particles characterization
- Z-average particle size. Expected particle size - 5-35 nm, perhaps more - up to 100 nm. Method - dynamic light scattering(DLS), preferably multi-angle dynamic light scattering with non-invasive back-scatter(MADLS with NIBS).
- Polydispersity Index(PDI).
- Zeta Potential. Method - electrophoretic light scattering(ELS).

2. Crystal structure characterization
- Powder X-ray diffraction.

3. Fe(II) contents determination
- Polarographic method in accordance with instructions from DMF.
1. These tests can be run on ZetaSizer range by Malvern Panalytical. Quartz cuvettes should be used for size characterization to avoid interference of plastic cuvettes with the intensity of the light scattered from the iron sucrose particles.

2. Diffractograms pinned to DMF will be available for comparison. We are interested in similarity assessment.

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