Determination of hydrazine in a meningococcal C conjugate vaccine intermediary product

• Published in: Vaccine 2010-08, Vol.28 (34), p.5648-5651
• Main Authors: Bastos, Renata Chagas, de Carvalho, Juliana Machado, da Silveira, Ivna Alana Freitas Brasileiro, do Couto Jacob, Silvana, Leandro, Katia Christina
• Format: Article
• Language: English
• Subjects: Acids; Allergy and Immunology; Applied microbiology; Bacteriology; Biological and medical sciences; Disease; Electrodes; Fundamental and applied biological sciences. Psychology; Hydrazine; Hydrazines - analysis; Meningitis; Meningococcal vaccine; Meningococcal Vaccines - chemical synthesis; Methods; Microbiology; Miscellaneous; Molecular weight; Neisseria meningitidis; Pharmaceutical industry; Polarography; Polarography - methods; Process control; Process controls; Proteins; Studies; Sulfuric acid; Tetanus; Tetanus Toxoid - immunology; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Voltammetry
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2010.05.079

Abstract In Brazil, polysaccharide–protein conjugate vaccine against Neisseria meningitidis group C (MenCPS-TT) using hydrazine-activated-tetanus toxoid (TT) as a carrier protein has been developed. Because of the toxicity of hydrazine in humans, it is necessary to monitor this substance's process control step during the vaccine production. The electroanalytical methodology was developed and validated for the determination of hydrazine during the process control of MenCPS-TT vaccine production by differential pulse polarography. The reduction potential was −0.95 V in acetone and sulphuric acid solution. The method presented linear range between 30 and 150 μg L−1 and recovery of 93.5 ± 0.8%.