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PhenylalanineEP8征求意见稿.docx

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PhenylalanineEP8征求意见稿.docx

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PhenylalanineEP8 征求意见稿
Reference: PA/PH/Exp. 10D/T (12) 6 ANP1
NOTE ON THE MONOGRAPH!
Ninhydrin-positive substances: TLC replaced by chromatography using an amino acids analyser which also allows quantification of
Assay: end-point determination by colour indicator replaced by potentiometric end-point
XXXX:07825
PHENYLALANINE6
Phenylalaninum7
H NH2
82H8
C9HnNO,9
Mr [63-91-2]ll
DEFINITIONS
(2S)-2-Aniino-3-phenylpropanoic
Fermentation product. 14
Content: per cent to per cent (dried substance). 15
CHARACTERS16
Appearance: white or almost white, crystalline powder, or shiny, white flakes. 17
Solubility: sparingly soluble in water, very slightly soluble in ethanol (96 per cent). It dissolves in dilute mineral acids and in dilute solutions of alkali hydroxides. 18
IDENTIFICATION^
First identification: A, A 20
Second identification: A9 C9
A. Specific optical rotation (see Tests).22
B. Infrared absorption spectrophotometry (・24).23
PrgpaMt沁r; diK3・24
Comparisons phenylalanine CRS. 25
C. Thin-layer chromatography ().26
Test solution. Dissolve 10 mg of the substance to be examined in a mixture of equal volumes of glacial acetic acid R and water R and dilute to 50 niL with the same mixture of Reference solution