TEST FOR HEMOLYTIC POTENTIAL OF PHARMACEUTICAL PRODUCTS AND FORMULATIONS FOR RISK MINIMIZATION

A non-hemolytic acidic composition comprising an immunoglobulin selected from immunoglobulin A, immunoglobulin G or immunoglobulin M at a pH value in the range of 4.65 to 5.7 comprising one or more excipients selected from amino acids, sugars and sugar alcohols in a concentration range of 100-350 mm...

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Bibliographische Detailangaben
Hauptverfasser:	SVAE TOR-EINAR, ROEMISCH JUERGEN, HEGER ANDREA, ZOECHLING ALFRED
Format:	Patent
Sprache:	eng
Schlagworte:	CHEMISTRY HUMAN NECESSITIES HYGIENE INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES MEASURING MEDICAL OR VETERINARY SCIENCE METALLURGY ORGANIC CHEMISTRY PEPTIDES PHYSICS PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES TESTING
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Beschreibung
Zusammenfassung:	A non-hemolytic acidic composition comprising an immunoglobulin selected from immunoglobulin A, immunoglobulin G or immunoglobulin M at a pH value in the range of 4.65 to 5.7 comprising one or more excipients selected from amino acids, sugars and sugar alcohols in a concentration range of 100-350 mmol/l, in particular 200-350 mmol/l, characterized in that it displays an optical density (OD) in the range of 0.14 to −0.1 when the OD is determined in a spectrophotometer at 414 nm at a film thickness of 0.825 mm; and its use in an assay for determination of the hemolytic potential of intravenously applied pharmaceuticals and compositions and preparations displaying a reduced potential of hemolysis when being applied intravenously.