Objective: To establish a recombinant C-factor method to detect the content of bacterial endotoxin in recombinant type Ⅲ humanized collagen solution for injection. Methods: Three batches of injectable recombinant type Ⅲ humanised collagen solutions were determinedand method validation by using the BIOMERIEUX recombinant C-factor kit and the lonza recombinant C-factor kit,respectively. Results: The results showed that about the two kits the concentration points of the standard curve were ≥ 3, and the linear correlation coefficient was r > 0.980, the ΔRFU value of the negative control was smaller than that of the lowest point of the standard curve; the bacterial endotoxin contents were all < 6 EU · mL-1. The reproducibility was good, the recoveries of bacterial endotoxin were in the range of 50%-200%, which was in accordance with the standard requirements of the ChP. Conclusion: The bacterial endotoxin content in the solution of recombinant type Ⅲ humanized collagen solution for injection is determined by the two kits. The results were < 0.05 EU · mL-1 and < 0.005 EU · mL-1, which are in accordance with the standard requirements for bacterial endotoxin in the product, respectively. The method can be used for the determination of bacterial endotoxin content in the solution of recombinant type Ⅲ humanized collagen solution for injection. This study provides a reference for the research related to the determination of endotoxin in recombinant protein products using recombinant C-factor method.
LI Ling
,
CHENG Xiao
,
WANG Jian
,
LIAN Kai-na
,
ZHANG Hong
,
FAN Yu-hui
,
SUN Dan-dan
,
YU Yu-feng
. Determination for the bacterial endotoxin of recombinant typeⅢhumanized collagen solution for injection by the recombinant C-factor method[J]. Chinese Journal of Pharmaceutical Analysis, 2025
, 45(3)
: 530
-536
.
DOI: 10.16155/j.0254-1793.2024-0498
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