THIMEROSAL USP/BP/EP
Thimerosal is manufactured by GIHON Químicos Laboratories SRL, meeting all the Pharmacopoeias and specifications required for such a complex chemical compound (USP, BP, EP, JP, FP). Its use is well established as an anti-infective, antimicrobial and antifungal agent, at quite low doses and with a wide spectrum. It is employed as a bacteriostatic agent and preservative in several different pharmaceutical formulations, like ophthalmic liquid preparations and topical antifungal formulations and in a vast range of veterinary products.
However, its more critical application is as a bacteriostatic agent in vaccines since the 1940s. Thimerosal is the preservative most widely used in vaccines due to its efficiency, effectiveness and low cost: for instance, Hepatitis B vaccine and many others, mainly in the case of multidose formulations. It was approved decades ago by the FDA and similar regulatory agencies in other countries and the FDA estimates that it is used in more than 30 licensed vaccines and biologics. Data regarding the content of Thimerosal in end-products varies a lot depending on the type of vaccine, if it is produced in mono-dose or multi-dose. A typical vaccine formulation containing Thimerosal includes only the specific antigen and Thimerosal (and in some cases, some kind of adjuvant, like alum). The power of Thimerosal in those applications allows for concentrations as low as 50 ppm. For instance, the Hep B vaccine contains approximately 0.01 p/v % in the 0.5 ml dose.
Its antibacterial activity is due to its slow hydrolysis, producing ethyl-mercury hydroxide. The latter is highly toxic to bacteria even at very low concentrations, whereas it is much less toxic to higher animals. Thimerosal is an important preservative that protects vaccine against bacterial contamination. Disease outbreaks have occurred following contamination of multi-dose vaccine vials in the United States and from other countries. For example, in April, 1995, three infants died in India from toxic shock
syndrome after administration of contaminated measles vaccine at one health centre. Therefore, the WHO advocates for a continued use of vaccines with the standard content of Thimerosal, which are less costly and more effective.
Product Specifications:
THIMEROSAL USP/ BP / EP
Formula: C9H9HgNaO2S
CAS Nr.: [54-64-8]
Molecular Weight: 404.81
m.p. 232ºC - 233ºC (dec)
Solubility: 1 gr in 1 ml water / 1 gr in 8 ml ethanol, practically insoluble in ethyl ether and benzene
Available:
- Statement of Free BSE / TSE
- Statement of Free Residual Solvent Content
- Statement of Not GMO (Genetically Modified Organism)
- Statement of ECO (Exclusively from Chemical Origin)
- DMF (Drug Master File – Open Part)
