Contrast Media — Manufacturer & Supplier

Iodinated and gadolinium-based imaging agents — large-volume aseptic fill in vials and bottles, with viscosity, osmolality and particulate control.

Contrast media is the formulation family most contract sites quietly decline. Fill volumes run to 100 ml and beyond, the solutions are viscous, osmolality and endotoxin limits are tight, and particulate control has to hold across a long fill with no terminal recovery step for parenteral grades. Our capability is built for exactly that: aseptic and terminally sterilised filling with in-line filtration, nitrogen overlay where the molecule requires it, automated 100% visual and particulate inspection, and release testing that includes osmolality, pH, assay by HPLC, free iodide or free gadolinium where applicable, bacterial endotoxin and sterility. Listed formulations describe manufacturing capability and qualified facility scope. They are not an offer of approved or marketed products, and any supply is subject to the customer holding the applicable marketing authorisation for the destination market.

Manufactured under the Stancor Pharma brand by Stancor Pharma.

Specifications

Iodinated formulations (capability)
Iohexol, iopamidol, iodixanol, ioversol, iopromide — 300, 350 and 370 mg I/ml strengths
Gadolinium formulations (capability)
Gadoterate meglumine, gadobutrol, gadodiamide — 0.5 mmol/ml class presentations
Presentations
10, 20, 50, 100 ml vials and 100-500 ml infusion bottles; pre-filled syringe on request
Batch envelope
50 L to 2,000 L per batch, campaign scheduling available
Sterilisation route
Terminal moist heat where the monograph permits, otherwise aseptic with 0.22 µm in-line filtration
Release testing
Assay (HPLC), osmolality, pH, free ligand, particulate matter, BET, sterility, container closure integrity

Contrast Media Applications

Applicable Standards & Specifications

Available Grades