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Guideline on setting specifications for related impurities ...

7 Westferry Circus Canary Wharf London E14 4HB United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail Wbsite European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged. 30 June 2012 EMA/CHMP/CVMP/QWP/199250/2009 corr Committee for Medicinal Products for Human Use (CHMP)/ Committee for Medicinal Products for Veterinary Use (CVMP) Guideline on setting specifications for related impurities in antibiotics Final Draft Agreed by Quality Working Party May 2010 Adoption by CHMP for release for consultation 24 June 2010 Adoption by CVMP for release for consultation 15 July 2010 End of consultation (deadline for comments) 31 Jan 2011 Agreed by Quality Working Party May 2012 Adoption by CHMP 14 May 2012 Adoption by CVMP 14 June 2012 Date for coming into effect 30 June 2013 Keywords Antibiotics, specifications , related impurities Guideline on setting specifications for related impurities in antibiotics EMA/CHMP/CVMP/QWP/199250/2009 corr 2/15 Guideline on setting specifications for related impurities in antibio

for their impurities. ... related impurities in antibiotics (i.e. antibacterial substances) that are fermentation products or semi- ... The applicant should provide a discussion on potential impurities, how they are removed and which impurities appear in the active substance.

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  Antibacterial, Their, Potential

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