Reference Materials
This article was originally published in SRA
Executive Summary
Argentina establishes material for evaluation of gramicidin
Argentina establishes material for evaluation of gramicidin
The Argentinian National Administration of Medicines, Foods and Medical Technology, Anmat, has issued a regulation establishing the primary reference substance for microbiological evaluations of gramicidin1. Gramicidin is an antimicrobial cyclic polypeptide produced by the growth of bacillus brevis dubos that acts against a wide range of bacteria. It is used alone or in combination with other topical antibiotics or antiseptics in ointments, solutions or sprays for the treatment of infected burns, ulcers and wounds.
The reference material is packed in vials containing approximately 200mg of gramicidin with a given potency of 1118 IU/mg, expressed in dried substance, as determined in comparison with gramicidin CRS, Lot 1, established by the European Pharmacopoeia Commission. The standards will be stored at the National Institute of Medicines (INAME) and will be supplied to applicants subject to payment of the corresponding fee. The vials will be supplied with a summary of the complementary technical information.
MIGUEL JC NAPOLITANO
References
1. Anmat Disposici�n 6975/2006, 23 November 2006, Boletín Oficial de la República Argentina, No 31.072, 12 January 2007