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Commission Directive 2008/84/EC (repealed)Show full title

Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance) (Codified version) (repealed)

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Changes over time for: E 235 NATAMYCIN

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E 235 NATAMYCINU.K.

SynonymsPimaricin
DefinitionNatamycin is a fungicide of the polyene macrolide group, and is produced by natural strains of Streptomyces natalensis or of Streptococcus lactis
Einecs231-683-5
Chemical formulaC33H47O13N
Molecular weight665,74
AssayContent not less than 95 % on the anhydrous basis
DescriptionWhite to creamy-white crystalline powder
Identification
A.Colour reactions

On adding a few crystals of natamycin on a spot plate, to a drop of:

  • concentrated hydrochloric acid, a blue colour develops,

  • concentrated phosphoric acid, a green colour develops,

which changes into pale red after a few minutes

B.Spectrometry
A 0,0005 % w/v solution in 1 % methanolic acetic acid solution has absorption maxima at about 290 nm, 303 nm and 318 nm, a shoulder at about 280 nm and exhibits minima at about 250 nm, 295,5 nm and 311 nm
C.pH
5,5 to 7,5 (1 % w/v solution in previously neutralised mixture of 20 parts dimethylformamide and 80 parts of water)
D.Specific rotation
[α]D 20 = + 250o to + 295o (a 1 % w/v solution in glacial acetic acid, at 20 oC and calculated with reference to the dried material)
Purity
Loss on dryingNot more than 8 % (over P2O5, in vacuum at 60 oC to constant weight)
Sulphated ashNot more than 0,5 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 10 mg/kg
Microbiological criteria: total viable countNot more than 100/g

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