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2012, Number 3

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VacciMonitor 2012; 21 (3)

Validation of the LAL method for the determination of bacterial endotoxins in injectable sodium heparin

Burguet N, Brito LC

Language: Spanish
References: 21
Page: 32-36
PDF size: 164.99 Kb.


ABSTRACT

The United States Pharmacopoeia, in the quality control of pharmaceutical products, establishes the quantification of bacterial endotoxins by the Limulus amebocyte lysate method as pyrogen monitor for more than 90% of the parenteral Solutions it regulates. This method was specifically applied to bacterial and viral vaccines, antineoplastic agents, radiopharmaceutical and parenteral drugs produced in the pharmaceutical medical industry. This paper shows the methodology followed to perform the validation of the technique for the determination of bacterial endotoxins by the method of gelation. For that reason, the sensitivity of the reagent used (0.03125 EU / mL) and the validity of the analysts to obtain reliable results were confirmed. Preliminary tests for the assay product sodium Heparin 5000 IU/mL showed that this product does not enhance or inhibit the reaction of the reagent. A working dilution (1/128) was chosen to validate the method. Thus, the conditions for the validation of test Limulus amebocyte lysate gelation were standardized in this parenteral product. Therefore, the method is extended to the determination of bacterial endotoxins in vaccines and other medicines which administration route is intravenous.


REFERENCES

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