High-performance liquid chromatography in the quality control of immunoglobulin preparations during production and storage.
High-performance liquid chromatography (HPLC) has been used in the routine quality control of immunoglobulin preparations to measure the contents of aggregates, dimers, monomers and degradation products. The correlation coefficients between TSK 3000 SW, Ultrogel AcA 34 and Sephacryl S-300 chromatography were calculated and a reasonable correlation was found. The decrease in the potency of anti-tetanus immunoglobulin at room temperature was accompanied by an increase in degradation products. The speed and high sensitivity of HPLC make it suitable for the detection of aggregates in intravenous immunoglobulin preparations.
D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D004356:Drug Storage; D006801:Humans; D007074:Immunoglobulin G / Q000032:analysis / Q000592:standards*; D008970:Molecular Weight; D011786:Quality Control; D013745:Tetanus Toxoid / Q000032:analysis / Q000592:standards
D007074:Immunoglobulin G; D013745:Tetanus Toxoid