Objective: To establish a bacterial endotoxin detection method for vidarabine monophosphate for injection and conduct methodological validation for harmanizing the quality control standard of this product.
Methods: According to the Chinese Pharmacopoeia 2020 volume Ⅳ general chapter 1143“Bacterial endotoxin test”, the limit of bacterial endotoxin was determined,interference test and endotoxin testing were performed.
Results: The bacterial endotoxin test were performed on 25 batches of test samples provided by 15 manufacturers according to the experienced experimented limitation which is the amount of endotoxin in 1 mg of adenosine monophosphate should be less than 0.06 EU. All results were found to be in compliance with the specified standards.
Conclusion: The established bacterial endotoxin method can be used for quality control of vidarabine monophosphate for injection.

The characteristics of virus-like particle (VLP) of JC virus (JCV) as a vector for targeting gene delivery was determined. The exogenous DNA (PUC19) packaged in VLP-Z was resistant to DNase I. VLP-Z was able to deliver a reporter plasmid pEGFP-N1 into HeLa cells and the green fluorescent reporter protein was expressed in these cells. VLP-Z was also able to bind IgG by interaction with the Z fragment of VLP-Z and IgG. These results suggested that VLP-Z might be used as a vector to deliver therapeutic genes to target cells with incorporating IgG antibodies.
Gene Targeting ; methods ; Gene Transfer Techniques ; Genetic Therapy ; methods ; Genetic Vectors ; genetics ; HeLa Cells ; Humans ; Immunoglobulin G ; metabolism ; JC Virus ; genetics ; metabolism ; Virion ; genetics ; metabolism