Investigations on pharmacopoeial safety, microbial sterility and pyrogens of Pr-β-HCG-TT

Gupta, L. ; Dubey, S. K. ; Talwar, G. P. (1976) Investigations on pharmacopoeial safety, microbial sterility and pyrogens of Pr-β-HCG-TT Contraception, 13 (2). pp. 183-187. ISSN 0010-7824

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Official URL: http://www.sciencedirect.com/science/article/pii/0...

Related URL: http://dx.doi.org/10.1016/0010-7824(76)90030-5

Abstract

Each batch of the vaccine Pr-β-HCG-TT was tested for pyrogens, microbial sterility and pharmacopoeial safety. 0.1 ml of the vaccine (diluted to 10.0 ml/kg body weight of the rabbit with pyrogen-free saline) when injected intravenously, did not cause rise in rectal temperature of the rabbits beyond 0.6°C individually or 1.4°C collectively in the three rabbits. The preparation inoculated in thioglycolate medium or meat broth and plated after 6 days in blood agar did not show any contamination in either of the media. The vaccine injected at five times full human dose level to guinea pigs did not cause any symptoms of tetanus nor any mortality in the animals.

Item Type:Article
Source:Copyright of this article belongs to Elsevier Science.
ID Code:50667
Deposited On:26 Jul 2011 07:59
Last Modified:26 Jul 2011 07:59

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