Objective: To establish the first batch of national reference material and the control material for hemocoagulase bothrops atrox. Methods: The physicochemical analysis, titer determination and stability testing of the reference material for hemocoagulase bothrops atrox were carried out. The structural identification, purity testing, physicochemical analysis and stability testing of the control for hemocoagulase bothrops atrox were carried out. Results: The titer of the hemocoagulase bothrops atrox used for titer determination was 101 units per ampoule. The control material with accurate structure and high purity was established for identification and testing. Conclusion: The establishment of the first batch of the reference material and the control material for hemocoagulase bothrops atrox can be applied to the quality control of drugs and lay a basis for the quality research on enzyme biochemical drugs.
Key words
hemocoagulase bothrops atrox;reference material;control material;first batch;quality analysis
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Footnotes
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