A QUANTITATIVE ASSAY FOR 4-PYRROLIDINOPYRIDINE (4-PPY) IN POLYSACCHARIDE-PROTEIN CONJUGATE VACCINES

The present invention relates to a rapid and reproducible Reversed Phase High Performance Liquid Chromatographic (RP-HPLC) based method for quantifying residual 4-pyrrolidinopyridine(4-PPY) in polysaccharide- protein conjugate vaccines prepared by cyanylation conjugation chemistry using 1-Cyano-4-py...

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Bibliographic Details
Main Authors ASHTAGI, SIDDHARAM CHANDRAKANT, PATIL, KUNDAN DHARMA, AVALSKAR, NIKHIL DATTATRAY, GAIROLA, SUNIL JAGDISHPRASAD
Format Patent
LanguageEnglish
French
German
Published 14.09.2016
Subjects
HUMAN NECESSITIES
HYGIENE
INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES
MEASURING
MEDICAL OR VETERINARY SCIENCE
PHYSICS
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
TESTING
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Summary:The present invention relates to a rapid and reproducible Reversed Phase High Performance Liquid Chromatographic (RP-HPLC) based method for quantifying residual 4-pyrrolidinopyridine(4-PPY) in polysaccharide- protein conjugate vaccines prepared by cyanylation conjugation chemistry using 1-Cyano-4-pyrrolidinopyridinium tetrafluorborate (CPPT).Said assay comprises of heating sample containing polysaccharide protein conjugate at a temperature between 60°C and 90°C for a duration between 2hrs and 3hrs followed by RP-HPLC.Further present method does not require any tedious sample preparation and none of the sample matrix interferes with the 4-PPY peak.Said method is applicable for quantification of 4-PPY in any polysaccharide-protein conjugate bulk or vaccine samples.
Bibliography:Application Number: EP20150159467