Validation and application of a SEC-HPLC method for the determination of total protein in therapeutic immunoglobulins as an alternative to the European Pharmacopoeia methods.

Esposito, V; Carocci, A; Luciani, F; Battistone, A; Gaggioli, A; Esposito, F

Esposito, V; Carocci, A; Luciani, F; Battistone, A; Gaggioli, A; Esposito, F.

Affiliation

Esposito V; National Centre for the Control and Evaluation of Medicines, Istituto Superiore di Sanità, viale Regina Elena, 00161, Rome, Italy.
Carocci A; National Centre for the Control and Evaluation of Medicines, Istituto Superiore di Sanità, viale Regina Elena, 00161, Rome, Italy.
Luciani F; National Centre for the Control and Evaluation of Medicines, Istituto Superiore di Sanità, viale Regina Elena, 00161, Rome, Italy.
Battistone A; National Centre for the Control and Evaluation of Medicines, Istituto Superiore di Sanità, viale Regina Elena, 00161, Rome, Italy.
Gaggioli A; National Centre for the Control and Evaluation of Medicines, Istituto Superiore di Sanità, viale Regina Elena, 00161, Rome, Italy.
Esposito F; National Centre for the Control and Evaluation of Medicines, Istituto Superiore di Sanità, viale Regina Elena, 00161, Rome, Italy.

Pharmeur Bio Sci Notes ; 2023: 69-81, 2023.

Article de En | MEDLINE | ID: mdl-37961820

Sujet(s)
Mots clés

European Pharmacopoeia; HPLC; method validation; plasma-derived medicinal products; protein content

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Collection: 01-internacional Base de données: MEDLINE Sujet principal: Immunoglobulines Limites: Humans Langue: En Journal: Pharmeur Bio Sci Notes Sujet du journal: FARMACOLOGIA Année: 2023 Type de document: Article Pays d'affiliation: Italie Pays de publication: France

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