With the rapid development of the biopharmaceutical industry in China, while paying attention to the key quality attributes of biological macromolecules themselves, we have also seen the impact of excipients and process residues in biological drug preparations on the quality of biological drugs. A large part of the excipients and residual compounds in the production process in biological preparations have not been absorbed by ultraviolet, and the chemical structure is not a single structural compound, so the difficulty of analysis will be much greater.
For this kind of non-single compound analysis micro-source detection laboratory has carried out a series of work, from a number of different perspectives to develop a variety of unique analytical methods, targeted for biopharmaceutical excipients and process residues to propose solutions, today to share a method on the detection of defoamer residues in biological fermentation broth.
Verify some of the content:
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Acceptable standards
Exclusivity
Solvent interference
The blank solution is undisturbed at the target peak retention time
System suitability
For the target peak response value of the illuminated solution for consecutive 6≤10%, the correlation coefficient of the calibration curve ≥0.99
Detection and quantification limits
Detection limit solution signal-to-noise ratio ≥3
The signal-to-noise ratio of the quantitative limit solution ≥10
Quantitative limit solution continuous 6-pin response value RSD≤10%
Linear and range
The correlation coefficient R≥0.99 for the standard curve linear regression equation
accuracy
The recovery rate of 50%, 100%, and 150% of the standard-added solution is in the range of 80% to 120%.
Recovery rate of 9 parts of the standard-added solution RSD≤10%
precision
repeatability
The recovery rate of 100% standard-labeled solution is in the range of 80%-120%, and the recovery rate of 6 parts of 100% standard-labeled solution is RSD≤10%
Intermediate precision
The recovery rate of 100% standardized solution is in the range of 80% to 120%.
6 parts 100% standard-labeled solution recovery RSD≤10%
Total RSD recovery of 12 parts of 100% standard-added solution in two experiments≤15%
Solution stability
The response value of the 100% standard-labeled solution at each time point and 0 h | RD|≤15%
Figure 1: Blank image
Figure 2: Comparison diagram
In this method, at the level of defoamer concentration, the detector and defoamer concentrations are exponentially related, that is, (A is the peak area, C is the concentration, a and b are the coefficients obtained by fitting), and the change in the relationship is obtained, and lgA and lgC can be obtained as a linear relationship (b is the slope, lga is the intercept), which is used as the basis for quantitative calculation. At the same time, another relation can be obtained, whether the concentration is stable is determined by the peak area (1 / slope) power, and the peak area (1 / slope) power (hereinafter referred to as the response value) is used to investigate the applicability and stability of the system.
Micro-source detection official website - drug quality research, impurity research, structural confirmation, biological drug analysis, methodological development and verification