Commission Directive 2008/84/EC (repealed)Show full title

E 235 NATAMYCIN U.K.

Synonyms	Pimaricin
Definition	Natamycin is a fungicide of the polyene macrolide group, and is produced by natural strains of Streptomyces natalensis or of Streptococcus lactis
Einecs	231-683-5
Chemical formula	C33H47O13N
Molecular weight	665,74
Assay	Content not less than 95 % on the anhydrous basis
Description	White 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 drying	Not more than 8 % (over P2O5, in vacuum at 60 oC to constant weight)
Sulphated ash	Not more than 0,5 %
Arsenic	Not more than 3 mg/kg
Lead	Not more than 5 mg/kg
Mercury	Not more than 1 mg/kg
Heavy metals (as Pb)	Not more than 10 mg/kg
Microbiological criteria: total viable count	Not more than 100/g