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VITAMIN B2 RIBOFLAVIN 5 PHOSPHATE POWDER - DFI-024008

Published: 16/04/2019

Description

Shelf life24 Months
DescriptionYellow to Orange crystalline hygroscopic powder with slight odour
Aroma(Primary Aromatic Amine) Max:70mg/kg

Specification

SolubilitySoluble in water, very slightly soluble in alcohol, practically insoluble in ether.
Identification A(Light absorption)By U.V & Visible absorption spectrophotometry. Spectral range: 230-350 nm. Absorption maximum: at 266nm. The absorbance at 266 nm is 0.58 to 0.64.
Identification B(By HPLC test)The retention of the major peak of the solution chromatogram obtained in related substances corresponds to that of the solution major peak.
pH(1% solution)5 to 6.5
Specific Optical Rotation38 to 42+°
LumiflavinShake 35 mg with 10 ml of dichloromethane for 5 minutes and filter. The filtrate is not more intensely coloured than reference solution BY
Related Substances(Free Riboflavin (HPLC)) Max:6%
Related Substances(Free Riboflavin Diphosphate HPLC)) Max:6%
Loss on drying Max:7.5%
Assay(of Riboflavin on dry basis)73 to 79%
Residue on ignition Max:25%
Phosphate(Inorganic) Max:1%
Organic Volatile Impurities(as Methanol) Max:3000ppm
Acetonitrile Max:410ppm
Benzene Max:2ppm
Content(Pyridine) Max:200ppm
Identification C(Fluorescence Test)The lower phase mixture present yellow fluorescence.
Identification D(Reaction of sodium salt & phosphate)The filtrated respond to sodium ions reaction & phosphate ions reaction.
Spectrometry(in aqueous solution. As per E 101)The ratio A375/A257 is between 0.30 and 0.34. The ratio A444/A267 is between 0.35 and 0.40
Arsenic Max:3mg/kg
Lead Max:2mg/kg
Mercury Max:1mg/kg
Cadmium Max:1mg/kg
Endotoxin Max:7.1IU/mg

Microbiological

Bacterial Count Max:1000cfu/g
Total Fungal Count Max:100cfu/g
Escherichia ColiAbsent /1g
SalmonellaAbsent in 1g
Staphylococcus aureusAbsent in 1g
Pseudomonas aeruginosaAbsent in 1g

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