Verification of the test procedure for a Haemophilus type b conjugate vaccine by determination of capsular polysaccharide

Introduction. Many developed countries in the world have included vaccine against infection caused by Haemophilus influenzae type b in their national immunization programs. One of the main quality indicators of vaccine is its specific activity determined by the content of the capsular polysaccharide polyribosylribitol phosphate (PRP). Objective: to verify the spectrophotometric determination of phosphorus for the control of hemophilustype b capsular polysaccharide conjugate vaccine in accordance with the requirements of the 14th Edition of the State Pharmacopoeia of the Russian Federation (RF SP-14). Material and methods. The investigation object was a hemophilus type b conjugate vaccine, lyophilisate for solution for intramuscular injection. The procedure given in GPA 1.7.2.0017.15 «Spectrophotometric Determination of Phosphorus in Biological Agents» was verified in accordance with the requirements of the RF SP-14. Results. While verifying the procedure, the investigators estimated the following parameters: correctness, reproductibility, and intralaboratory precision. The results were found to be dissimilar. The optimal conditions for the procedure were selected for the subject and standard (calibration) samples; it was recommended to use a single control sample. Samples should be prepared under similar conditions. Conclusion. The procedure for spectrophotometric determination of phosphorus has been optimized, which makes it possible to obtain reliable results by the quantitative indicator capsular polysaccharide for the hemophilic type b conjugate vaccine, lyophilisate for solution for intramuscular injection.

capsular polysaccharide, polyribosylribitol phosphate, Haemophilus influenzae type b, spectrophotometry, verification