ASSESSMENT OF STABILITY OF BIOLOGICAL PREPARATION IN PRE-FILLED SYRINGES Russian patent published in 2021 - IPC G01N33/68 G01N30/06 G01N30/72 C07K7/06 

FIELD: chemistry; pharmaceutics.

SUBSTANCE: invention relates to the field of chemistry and pharmaceutics, namely, to a method for determining the percentage of decomposition of a compound of the formula (I) as a result of contact to a part of a container for medical use. The method includes obtaining an aqueous solution containing a certain amount of a compound of the formula (I): , where each of X, R₁, R₂, R₃, R₄, R₅ is certain substituents, n and m independently are an integer from 0 to 10; adding a part of a container for medical use to the solution for a period of time from 1 hour to 2 months, at a temperature of 5-80°C; analyzing the resulting solution by liquid chromatography; determining the percentage of decomposition.

EFFECT: invention provides a method for simulating and assessing the chemical decomposition of a biological preparation in contact to a part of a container for medical use when using a compound of formula (I) as a model compound.

10 cl, 4 dwg, 3 ex